20 results
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16ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Maquet Orchide OR Light Systems, Model Numbers and Catalog Numbers OHDII FHD QL VP01 - ARD568803935, OHDII FHD QL AIR03 U - ARD568803952, OHDII FHD QL AIR03 E - ARD568803967, OHDII FHD QL AIR04 E/U - ARD568803968, OHDII FHD QL+ VP01 - ARD569204944, OHDII AIR03 QL FHD E - ARD568803951
FDA Enforcement
Class II
·Ongoing·Getinge Usa Sales Inc·January 24, 2024
AEM Disposable Electrodes, Device, Electrosurgical, Cutting and Coagulation and Accessories. AEM Disposable Electrodes used as electrosurgical accessories intended for ablation, removal, resection and coagulation of soft tissue in open, endoscopic and laparoscopic surgical procedures channeling monopolar high-frequency electrical current from compatible electrosurgical generators. The device is model FC03XX series. AEM Disposable Electrodes used as electrosurgical accessories intended for ablation, removal, resection and coagulation of soft tissue in open, endoscopic and laparoscopic surgical procedures channeling monopolar high-frequency electrical current from compatible electrosurgical generators.
FDA Enforcement
Class II
·Terminated·Encision, Inc.·July 18, 2012
Covidien ROTICULATOR 55-3.5 Single Use Stapler REF# 017612 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis
FDA Enforcement
Class II
·Terminated·Covidien LP·June 27, 2012
Covidien ROTICULATOR 55-4.8 Single Use Stapler REF# 017614 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis
FDA Enforcement
Class II
·Terminated·Covidien LP·June 27, 2012
Covidien ROTICULATOR 30-3.5 Single Use Stapler REF# 017615 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis
FDA Enforcement
Class II
·Terminated·Covidien LP·June 27, 2012
Covidien ROTICULATOR 30-4.8 Single Use Stapler REF# 017617 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis
FDA Enforcement
Class II
·Terminated·Covidien LP·June 27, 2012
Covidien ROTICULATOR 30-V3 Single Use Stapler REF# 017619 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis
FDA Enforcement
Class II
·Terminated·Covidien LP·June 27, 2012
VOLISTA StandOP (model 600) surgical lights shipped from October 2012 until June 2017 equipped with keypads with Ref. ARD568801560; Part numbers: 568811901, VLT600SF AIM STP; 568811911, VLT600SF AIM STP; 568811961, VLT600DF AIM STP; 568821910, VLT600SF STP QL; 568821911, VLT600SF AIM STP QL; 568821960, VLT600DF STP QL; 568821961, VLT600DF AIM STP QL VOLISTA surgical lights are intended to be used to provide visible illumination of the surgical area or patient during surgical operations, diagnostics and treatment.
FDA Enforcement
Class II
·Terminated·Maquet SAS·June 6, 2018
PERSONA The Personalized Knee System Constrained Tibial Articular Surface Provisional BOTTOM with the following: L CD +0MM; L CD +6MM; L EF +0MM;L EF +6MM; L GH +0MM; L GH +6MM; L J +0MM; L J +6MM; R CD +0MM; R CD +6MM; R EF +0MM; R EF +6MM; R GH +0MM; R GH +6MM; R J +0MM; R J +6MM; and
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·September 10, 2014
VOLISTA StandOP Surgical Light, ARD568811961 VLT600DF AIM STP; ARD568821961 VLT600DF AIM STP QL; ARD568811911 VLT600SF AIM STP; ARD568821911 VLT600SF AIM STP QL; ARD568821910 VLT600SF STP QL; ARD568811901 VLT600SF AIM STP Product Usage: The Maquet VOLISTA surgical lights are designed to illuminate the body of a patient during surgical operations, diagnostics and treatment. StandOP VOLISTA is a system of ceiling-mounted surgical lights suited for installation in surgical suites, examining rooms, doctors surgeries and out-patient consultations.
FDA Enforcement
Class II
·Terminated·Maquet SAS·July 25, 2018
Persona (TM) The Personalized Knee System Tibial Articular Surface Provisional Bottom Nonsterile PSN A/S PROV L CD BOTTOM +0MM PSN A/S PROV L CD BOTTOM +6MM PSN A/S PROV L EF BOTTOM +0MM PSN A/S PROV L EF BOTTOM +6MM PSN A/S PROV L GH BOTTOM +0MM PSN A/S PROV L GH BOTTOM +6MM PSN A/S PROV L J BOTTOM +0MM PSN A/S PROV L J BOTTOM +6MM PSN A/S PROV R CD BOTTOM +0MM PSN A/S PROV R CD BOTTOM +6MM PSN A/S PROV R EF BOTTOM +0MM PSN A/S PROV R EF BOTTOM +6MM PSN A/S PROV R GH BOTTOM +0MM PSN A/S PROV R GH BOTTOM +6MM PSN A/S PROV R J BOTTOM +0MM PSN A/S PROV R J BOTTOM +6MM
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·August 27, 2014
Persona (TM) The Personalized Knee System Tibial Articular Surface Provisional Bottom Nonsterile TASP L CD BOTTOM, +0MM TASP L CD BOTTOM, +6MM TASP L EF BOTTOM, +0MM TASP L EF BOTTOM, +6MM TASP L GH BOTTOM, +0MM TASP L GH BOTTOM, +6MM TASP L J BOTTOM, +0MM TASP L J BOTTOM, +6MM TASP R CD BOTTOM, +0MM TASP R CD BOTTOM, +6MM TASP R EF BOTTOM, +0MM TASP R EF BOTTOM, +6MM TASP R GH BOTTOM, +0MM TASP R GH BOTTOM, +6MM TASP R J BOTTOM, +0MM TASP R J BOTTOM, +6MM
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·August 27, 2014
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINOPLASTY CDS d. ACH PLASTICS BREAST-LF e. NE BREAST RECON CDS f. PLASTIC SURGERY CDS g. MINOR PLASTIC CDS h. GROTH BREAST CDS i. BREAST ABD j. MINOR/U-BAR CDS-LF k. PLASTIC BREAST CDS-LF l. BREAST-HERNIA-PORT CDS-LF m. DAY SURG PLASTIC CDS n. PLASTIC SURGERY PACK o. PLASTIC PACK-LF p. PLASTIC-GENERAL SURGERY PACK q. PLASTIC PACK-LF r. ABDOMINOPLASTY/BREAST s. PLASTIC PACK t. BREAST PACK u. PLASTIC SURGERY TRAY v. BREAST AUGMENTATION PACK w. FACE PACK x. LIPOSUCTION PACK y. UNIVERSAL PLASTIC PACK z. PLASTIC PACK aa. LIPOSUCTION PACK bb. MINOR BREAST PACK cc. PLASTICS PACK-LF dd. UPPER PLASTIC PACK-LF ee. BREAST MAJOR PACK-LF ff. CAM PARTIAL MASTECTOMY PACK gg. PLASTIC PACK hh. BREAST PACK ii. BREAST RECONS COMBO PK XM-LF jj. PLASTICS PACK kk. BREAST REDUCTION PACK ll. BREAST HERNIA PK mm. T PLASTY PACK nn. ASC PLASTICS PACK oo. PLASTICS PACK-LF pp. OCULOPLASTIC PICK PACK qq. PLASTIC SURGERY LF PACK rr. PLASTIC PACK ss. OCULAR PLASTIC PACK tt. CHEST BREAST PACK uu. BREAST PACK vv. MAJOR PLASTIC PACK ww. FACIAL PLASTICS PACK xx. PLASTIC PACK yy. BREAST PACK zz. CHEST/BREAST PACK aaa. BREAST PACK bbb. BREAST PACK LJ-LF ccc. SCRIPPS SW PLASTIC PACK ddd. BREAST PACK eee. BREAST PACK fff. PLASTIC SURGERY U-BAR PACK ggg. PHOENIXVILLE BREAST PACK hhh. LAB PLASTIC PACK #DF2 iii. PLASTIC PACK jjj. GENERAL PLASTIC PACK kkk. CHEST/BREAST lll. MAJOR PLASTIC PACK mmm. MAJOR BREAST PACK nnn. BREAST ABDOMINOPLASTY PACK ooo. DR HOLCOMB FACIAL PACK ppp. MAJOR PLASTIC BREAST PACK qqq. DIAZ PACK rrr. BREAST PACK sss. BREAST PACK ttt. CHEST PACK uuu. PLASTIC FACIAL PACK vvv. FACIAL PLASTICS PACK www. BLEPHAROPLASTY PACK xxx. BREAST PACK - MOISES yyy. PLASTIC PACK zzz. PLASTIC PACK aaaa. BREAST AUGMENTATION PACK bbbb. CHEST/BREAST cccc. BREAST PACK dddd. PLASTIC PACK eeee. PLASTICS PACK ffff. PLASTIC PACK gggg. CHEST BREAST PACK hhhh. PLASTIC PACK iiii. CAROLINA FACIAL PLASTIC PACK jjjj. BREAST PACK kkkk. CHEST BREAST PACK llll. BREAST DBL PROCED SUPPLEMENT mmmm. BREAST PACK nnnn. PLASTIC PACK oooo. PLASTICS PACK pppp. ESC PLASTICS PACK qqqq. FACE LIFT PACK rrrr. CHEST BREAST ssss. BREAST PACK tttt. MINOR PLASTIC PACK uuuu. #2 FACIAL PLASTY PACK vvvv. BBL PACK wwww. BASIC PACK xxxx. BREAST PACK yyyy. BREAST AUGMENTATION PACK zzzz. BREAST PACK aaaaa. MAJOR BREAST OR UNIVERSAL bbbbb. CHEST/BREAST-LF ccccc. CUSTOM PLASTIC PACK ddddd. CHEST/BREAST PACK eeeee. PLASTIC GENERAL PACK fffff. SPECIALTY FACIAL PLASTICS PACK ggggg. OCCULOPLASTICS PACK hhhhh. BREAST PACK iiiii. LIPOSUCTION PACK jjjjj. BREAST PACK kkkkk. PLASTICS PACK lllll. BREAST PACK mmmmm. BREAST REDUCTION PACK nnnnn. BREAST AUGMENTATION PACK ooooo. FACE/RHINOPLASTY PACK ppppp. BREAST PACK qqqqq. TUMMY TUCK PACK rrrrr. BREAST PACK sssss. PLASTICS PACK ttttt. BREAST/ABDOMINAL PACK uuuuu. PLASTIC PACK vvvvv. BREAST PACK wwwww. RECONSTRUCTION PACK xxxxx. PLASTIC PACK yyyyy. PLASTICS PACK zzzzz. PLASTICS PACK aaaaaa. GENERAL PLASTIC-LF bbbbbb. PLASTIC UNIVERSAL cccccc. BREAST HA-LF dddddd. BREAST eeeeee. PLASTIC ffffff. BREAST gggggg. MAJOR BREAST hhhhhh. CHEST/BREAST-MRMCASU iiiiii. BREAST RECONSTRUCTION PACK jjjjjj. CHEST/BREAST kkkkkk. BREAST PACK llllll. BREAST BIOPSY/MASTECTOMY mmmmmm. CHEST/BREAST-LF
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·February 15, 2023
Medline procedure kits labeled as: 1) AV FISTULA PACK, Pack Number DYNJ80088; 2) AV FISTULA PACK-LF, Pack Number DYNJ0131782J; 3) CABG, Pack Number DYNJ906462B; 4) CABG ACCESSORY PACK-LF, Pack Number DYNJ0261346U; 5) CARDIAC CATH PACEMAKER-LF, Pack Number DYNJ42997C; 6) CARDIAC CATH PACK, Pack Number DYNJ61256A; 7) CARDIAC CATH PACK-LF, Pack Number DYNJ61527; 8) CARDIAC CATH PACK-LF, Pack Number DYNJ53642C; 9) CARDIOVASCULAR PACK LJ-LF, Pack Number DYNJ49635F; 10) CAROTID PACK, Pack Number DYNJ0810062AI; 11) CASTRO CABG-COMPONENT PACK, Pack Number DYNJ44857T; 12) CATH PACK, Pack Number DYNJ59830A; 13) CHOG CARDIAC CATH PACK, Pack Number SYNJ10304B; 14) CICC, Pack Number DYNJ53854A; 15) CMHP PACEMAKER PACK, Pack Number DYNJ30217G; 16) DR NACKMAN VEIN PACK, Pack Number DYNJ56235; 17) ENDOVASCULAR AAA PACK-LF, Pack Number DYNJ55482F; 18) EP DEVICE, Pack Number DYNJ65916B; 19) EP STUDY PACK-LF, Pack Number DYNJ38059A; 20) FHZ PACEMAKER PACK, Pack Number DYNJ36931D; 21) GV OPEN HEART PACK, Pack Number DYNJ60618C; 22) HEART CABG CDS, Pack Number CDS983376Q; 23) HEART DRAPE & SUPPLY PACK, Pack Number DYNJ65226; 24) HH ARTERIOGRAM PACK, Pack Number DYNJ59466A; 25) LEX OPEN HEART, Pack Number DYNJ900968I; 26) MAJOR VASCULAR PACK SAFETY, Pack Number DYNJ54738C; 27) NIR PACK, Pack Number DYNJ63892A; 28) OPEN HEART, Pack Number DYNJ904261B; 29) OPEN HEART, Pack Number DYNJ904261B; 30) OPEN HEART, Pack Number DYNJ905021J; 31) OPEN HEART A PACK, Pack Number DYNJ04478R; 32) OPEN HEART ACC, Pack Number DYNJ23533D; 33) OPEN HEART CDS, Pack Number CDS840171AB; 34) OPEN HEART DRAPE PACK-LF, Pack Number DYNJ0382048N; 35) OPEN HEART PACK, Pack Number DYNJ45122C; 36) OPEN HEART PACK, Pack Number DYNJ55648; 37) OPEN HEART PACK, Pack Number DYNJ04381J; 38) OPEN HEART PACK & BASIN SET-LF, Pack Number DYNJ24300M; 39) OPEN HEART PACK-LF, Pack Number DYNJ0369758N; 40) OPEN HEART PART B PACK, Pack Number DYNJ43038N; 41) OPEN HEART SUPPLY, Pack Number DYNJ65641; 42) OPEN PACK, Pack Number DYNJ67442B; 43) PACEMAKER, Pack Number DYNJ59399I; 44) PACEMAKER IMPLANT PACK-LF, Pack Number DYNJ0373237M; 45) PACEMAKER PACK, Pack Number DYNJ66165; 46) PACEMAKER PACK, Pack Number DYNJ41134B; 47) PACEMAKER PACK, Pack Number DYNJ61260A; 48) PACEMAKER PACK, Pack Number DYNJ60635; 49) PACEMAKER PACK, Pack Number DYNJ42602C; 50) PACEMAKER PACK 0121271-LF, Pack Number DYNJ32897J; 51) PACEMAKER PACK CV-LF, Pack Number DYNJ39912B; 52) PACEMAKER PACK-LF, Pack Number DYNJ53112B; 53) PACEMAKER PACK-LF, Pack Number DYNJ51844B; 54) PACEMAKER PACK-LF, Pack Number DYNJ0854874R; 55) PEDI EP PACK, Pack Number DYNJ54750G; 56) PERMANENT PACING PACK-LF, Pack Number DYNJ22036F; 57) PK, OPEN HEART, Pack Number DYNJ44015B; 58) PK, OPEN HEART-CABG, Pack Number DYNJ45048C; 59) RR-ADULT PUMP PACK-LF, Pack Number DYNJ0394805N; 60) RRMC CAROTID PACK-2, Pack Number DYNJ33544L; 61) RR-PEDIATRIC PUMP PACK-LF, Pack Number DYNJ0394730P; 62) TAVR PACK, Pack Number DYNJ58386A; 63) THORACIC PACK, Pack Number DYNJ80309; 64) VASCULAR, Pack Number DYNJ45376G; 65) VASCULAR PACK, Pack Number DYNJ48288C; 66) VASCULAR PACK, Pack Number DYNJ54979; 67) VASCULAR PACK, Pack Number DYNJ64883C; 68) VASCULAR PACK, Pack Number DYNJ43945I; 69) VASCULAR PACK, Pack Number DYNJ43945I; 70) VASCULAR PACK, Pack Number DYNJ67426A; 71) VASCULAR PACK WRO-LF, Pack Number DYNJ41863C; 72) VASCULAR SUB, Pack Number DYNJ60681A; 73) VASCULAR SUB, Pack Number DYNJ60681A
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·April 2, 2025
Sterile Procedural Trays, labeled as the following: a. EP LAB PACEMAKER PACK b. OPEN HEART CDS c. OPEN HEART CDS d. AAA CDS e. OPEN HEART CDS f. PACEMAKER CDS g. HEART CDS h. VALVE PACK i. OPEN HEART CDS-3 j. OPEN HEART PACK k. OPEN HEART PACK l. OPEN HEART ADULT m. OPEN HEART CDS PART A n. GLENNON OPEN HEART CDS o. OPEN HEART CDS p. MEMORIAL MED CTR BYPASS q. OPEN HEART PEDS r. OPEN HEART CDS-4 s. OPEN HEART t. CAB CDS u. VASCULAR CDS v. VALVE CDS w. OPEN HEART PACK-LF x. VASCULAR CDS-LF y. OPEN HEART B CDS-LF z. CRANIOTOMY CDS aa. OPEN UROLOGY CDS-LF bb. TOTAL KNEE CDS cc. LOWER EXTREMITY CDS-LF dd. LAMINECTOMY CDS ee. ENDOVASCULAR CDS ff. VASCULAR gg. VASCULAR CDS-3 hh. VASCULAR ACCESS CDS ii. ZALE PUMP CDS jj. CUH ENDOVASCULAR CDS kk. CUH MINOR VASCULAR CDS ll. FHT CVOR CABG mm. OPEN HEART CDS nn. OPEN HEART CDS oo. CAROTID ENDARTERECTOMY CDS-LF pp. PACER CDS qq. PERIPHERAL VASCULAR CDS rr. ACH OPEN HEART ss. ACH OPEN HEART tt. OPEN HEART CDS uu. VASCULAR CDS vv. CV CDS ww. OPEN HEART CABG PACK-LF xx. MAJOR VASCULAR PACK-LF yy. CARDIOVASCULAR PACK-LF zz. VASCULAR HARPER PACK-LF aaa. CABG 1 OR 2 HARPER PACK bbb. TAVR 1 PACK-LF ccc. ENDO VASCULAR PACK-LF ddd. OPEN HEART A & B PACK eee. PACEMAKER IMPLANT PACK-LF fff. PERIPHERAL VASCULAR PACK-LF ggg. PACEMAKER PACK-LF hhh. RR-NEURO VASCULAR PACK-LF iii. CARDIAC CHEST PACK 80701 jjj. OPEN HEART PACK-LF kkk. PACEMAKER PACK-LF lll. CARDIOVASCULAR PACK-LF mmm. OPEN HEART PACK A & B nnn. MINOR VASCULAR PACK ooo. OPEN HEART PACK-LF ppp. SMALL VASCULAR PACK-LF qqq. MAJOR VASCULAR PACK-LF rrr. PEDIATRIC CARDIAC PACK-LF sss. OH VALVE PACK-LF ttt. HEART OVERHEAD TABLE PACK uuu. OPEN HEART PACK vvv. PACEMAKER PACK-LF www. VASCULAR PACK-LF xxx. OPEN HEART PACK yyy. VASCULAR PACK zzz. CV BASIC SET UP PACK aaaa. UNIVERSAL OPEN HEART PACK bbbb. VASCULAR BYPASS PACK-LF cccc. BMC CABG PACK A dddd. CUSTOM CAROTID eeee. A-V FISTULA PACK-LF ffff. PERIPHERAL VASCULAR PACK-LF gggg. ECMO PACK hhhh. HEART PACK iiii. CABG PACK A&B jjjj. OPEN HEART PACK kkkk. CV A & B llll. PEDIATRIC OPEN HEART-NS-LF mmmm. PACEMAKER NORTH nnnn. OPEN HEART PACK oooo. SVMMC CORE OPEN HEART PACK-LF pppp. PACEMAKER TRAY-LF qqqq. PACEMAKER PACK rrrr. MAJOR VASCULAR-RF-LF ssss. AV FISTULA-LF tttt. PACEMAKER PACK uuuu. VASCULAR PACK vvvv. PACEMAKER wwww. MAJOR VASCULAR PACK xxxx. MAJOR VASCULAR PACK yyyy. VASCULAR PACK zzzz. PACEMAKER PACK-LF aaaaa. RRMC CABG AUXILIARY TRAY bbbbb. RRMC OPEN HEART PACK ccccc. MAJOR VASCULAR PACK ddddd. PACEMAKER PACK eeeee. PACEMAKER TRAY fffff. PACEMAKER PACK ggggg. PACEMAKER PACK hhhhh. AV FISTULA PK-LF iiiii. FHT PACER PACK jjjjj. PACEMAKER SET UP PACK kkkkk. MAJOR VASCULAR PACK lllll. PACEMAKER PACK-LF mmmmm. CAROTID PACK nnnnn. MAJOR VASCULAR PACK ooooo. VASCULAR PACK GH-LF ppppp. A-V FISTULA PACK GH-LF qqqqq. VASCULAR PACK MH-LF rrrrr. PACEMAKER PACK L J sssss. OPEN HEART ttttt. OPEN HEART SUPPLY TRAY uuuuu. PACEMAKER PACK vvvvv. PACEMAKER PACK wwwww. VASCULAR PACK xxxxx. BASIC OPEN HEART PACK A B yyyyy. VASCULAR PACK zzzzz. OPEN HEART TRAY A-LF aaaaaa. VASCULAR PACK bbbbbb. PACEMAKER PACK cccccc. OPEN HEART PACK dddddd. ENDOVASCULAR PACK-LF eeeeee. VASCULAR PACK-LF ffffff. BASIC OPEN HEART PACK-LF gggggg. OPEN VASCULAR PACK-LF hhhhhh. PK, EP LAB PACEMAKER iiiiii. PK, OPEN HEART-CABG jjjjjj. OPEN HEART PACK kkkkkk. PK, OPEN HEART- A&B llllll. SVMMC VASCULAR MAJOR PACK mmmmmm. CV PACK nnnnnn. OPEN HEART PACK A AND B oooooo. SVMMC CAROTID PACK pppppp. PK, OPEN HEART-CABG A&B qqqqqq. PK, OPEN HEART-A&B rrrrrr. VASCULAR PACK ssssss. PK, OPEN HEART tttttt. PK, OPEN HEART uuuuuu. OPEN HEART PACK vvvvvv. PK, OPEN HEART-A&B wwwwww. OPEN HEART PACK xxxxxx. PK, OPEN HEART-CABG yyyyyy. PK, OPEN HEART zzzzzz. CASTRO CABG-COMPONENT PACK aaaaaaa. RE-ENTRY PACK bbbbbbb. HEART PACK ccccccc. OPEN HEART SUPPLY PACK ddddddd. PK, OPEN HEART-CABG eeeeeee. CABG PROCEDURE PACK fffffff. CABG PACK ggggggg. PK, OPEN HEART hhhhhhh. VASCULAR GRAFT PACK iiiiiii. PK, OPEN HEART jjjjjjj. VASCULAR PACK kkkkkkk. PK,
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·February 15, 2023
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ELECTROPHYSIOLOGY PACK-LF, Model Number: DYNJ0842825D; b. EMANUEL EP TRAY, Model Number: DYNJ49933I, DYNJ49933J; c. ENDO LASER ABLATION PK-LF, Model Number: DYNJ44808G; d. ENDO VASCULAR, Model Number: DYNJ51304B, DYNJ51304C; e. ENDO VASCULAR PACK, Model Numbers: DYNJ0678934D, DYNJ0678934F, DYNJ82567; f. ENDO VASCULAR PACK-LF, Model Number: DYNJ0676055N; g. ENDOVASCULAR, Model Numbers: DYNJ63343A, DYNJ63343B, DYNJ63343D, DYNJ63343F, DYNJ908880; h. ENDOVASCULAR CDS, Model Number: CDS983394I, CDS983394J, CDS983394K; i. ENDOVASCULAR IMF 88370-LF, Model Number: DYNJVB91067; j. ENDOVASCULAR KIT, Model Number: DYNJ906354D, DYNJ906354F; k. ENDOVASCULAR PACK, Model Number: DYNJ0678934I, DYNJ44934F, DYNJ905726C, DYNJ905726D; l. ENDOVASCULAR PACK-LF, Model Number: DYNJ42831F; m. ENDOVASCULAR -TEMPLE, Model Number: DYNJ67750, DYNJ67750A, DYNJ67750B, DYNJ67750C; n. ENDOVENOUS ABLATION PACK, Model Number: DYNJ80489; o. ENDOVENOUS BASIC PACK, Model Number: DYNJ48456C, DYNJ69108A; p. ENDOVENOUS PACK, Model Number: DYNJ83606; q. ENT FREE FLAP, Model Number: SYNJ910018B; r. EP ANGIO PACK, Model Number: DYNJ25749S; s. EP DRAPE PACK-LF, Model Number: DYNJ47645C; t. EP LAB, Model Number: DYNJ59392D, DYNJ59392F; u. EP PACER PACK, Model Number: DYNJ67770; v. EP PACK, Model Number: DYNJ23456K, DYNJ68019, DYNJ81716, DYNJ81716A, DYNJ81716B; w. EP PROCEDURE PACK, Model Number: DYNJ67771; x. EP TRAY, Model Number: DYNJ31928D; y. FEM POP BYPASS PACK-LF, Model Number: DYNJ53480F; z. FEM POP PACK, Model Number: DYNJ67487C; aa. FISTULA PACK, Model Number: DYNJ82711; bb. FISTULA SAVANNAH PACK, Model Number: DYNJ69943A; cc. GENERAL HEART, Model Number: DYNJ907915; dd. GROTH LASER VEIN CDS, Model Number: CDS984193O; ee. GV PERIPHERAL VASCULAR PACK, Model Number: DYNJ46590I, DYNJ46590J, DYNJ46590K; ff. GWINNETT ENDOVASCULAR WSTE MGT, Model Number: DYNJ68198; gg. HCP OPEN HEART ACCESSORY PACK, Model Number: DYNJ51925F; hh. HEART A PACK, Model Number: DYNJ0541930N; ii. HEART FAILURE PACK, Model Number: DYNJ64877B; jj. HEART FAILURE PK, Model Number: DYNJ55528A, DYNJ55528B, DYNJ55528C; kk. HEART PACK, Model Number: DYNJ48424A; ll. HEART VALVE PACK, Model Number: DYNJ58365C, DYNJ58365F, DYNJ58365G, DYNJ58365J; mm. HEART VEIN NYC-ARTERIAL PACK, Model Number: DYNJ62851B; nn. HEART VEIN NYC LASER ABLATION, Model Number: DYNJ62850A; oo. HMT TAVR, Model Number: DYNJ905495D, DYNJ905495F; pp. HMT VEIN PACK, Model Number: DYNJ38756B; qq. HP MINOR VASCULAR, Model Number: DYNJ907571A, DYNJ907571B; rr. INTERVENTIONAL RAD L J-LF, Model Number: DYNJ40215C; ss. INTERVENTIONAL RADIOLOGY, Model Number: DYNJ52756A; tt. INTERVENTIONAL RADIOLOGY PACK, Model Number: DYNJ47138B; uu. IR ANGIOGRAM LIGHT PK, Model Number: DYNJ82858A; vv. IR ANGIOGRAM PACK, Model Number: DYNJ82859A; ww. JVL-PACK VNUS CLOSURE, Model Number: DYNJ66076; xx. KIT CARDIAC ROBOTIC MID CAB, Model Number: DYKMBNDL22C; yy. KIT LB OPEN HEART, Model Number: CDS840487G; zz. KIT MAJOR VASCULAR, Model Number: DYNJ907262, DYNJ907262B; aaa. KIT NEURO CAROTID SETUP, Model Number: DYKMBNDL148A; bbb. KIT OPEN HEART, Model Number: DYNJ906113; ccc. KIT OR AORTOGRM ANGIOPLAST PHT, Model Number: DYNJ906086B; ddd. KIT VASCULAR AAA REPAIR, Model Number: DYKMBNDL23; eee. KIT VASCULAR ACCESS PHT, Model Number: DYNJ906098, DYNJ906098A; fff. KIT VASCULAR CAROTID, Model Number: DYKMBNDL118A; ggg. KIT VASCULAR RF, Model Number: DYNJ906960A; hhh. KT TAVR PACK, Model Number: DYNJ56283C, DYNJ56283D, DYNJ56283F; iii. LASER ABLATION, Model Number: DYNJ48962B; jjj. LASER AND VEIN PACK, Model Number: DYNJ38995C, DYNJ67725; kkk. LASER PACK, Model Number: DYNJ65294; lll. LB OPEN HEART BOX, Model Number: DYNJ905859B; mmm. LEE VEIN PACK, Model Number: DYNJ54906B; nnn. LEG VASCULAR SUPPLY -LF, Model Number: D
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·August 9, 2023
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY DRAPE PACK, Model Number 00-400305R; b) ANGIO HOLLAND PACK-LF, Model Number DYNJ0037936C; c) ANGIO HOLLAND PACK-LF, Model Number DYNJ0037936D; d) ANGIOGRAM, Model Number DYNJ0149444N; e) DIALYSIS CATH INSERTION PK-LF, Model Number DYNJ0198765G; f) PICC LINE PACK-LF, Model Number DYNJ0275614F; g) ANGIOGRAPHY PACK-LF, Model Number DYNJ0290716M; h) ANGIO CATH LAB PACK-LF, Model Number DYNJ0313233V; i) ANGIO CATH LAB PACK-LF, Model Number DYNJ0313233W; j) ANGIO CATH LAB PACK-LF, Model Number DYNJ0313233X; k) ANGIO PACK-LF, Model Number DYNJ0407399P; l) SPECIAL PROCEDURE PACK-LF, Model Number DYNJ0416535AA; m) VISCERAL ANGIOGRAM PACK-LF, Model Number DYNJ0429121K; n) CARDIAC EP PACK-LF, Model Number DYNJ0429185L; o) SPECIAL PROCEDURE PACK-LF, Model Number DYNJ0458661C; p) LT HEART/ANGIOGRAPHY PACK-LF, Model Number DYNJ0537652AG; q) CATH LAB ANGIO PACK-LF, Model Number DYNJ0545064AA; r) SPECIAL PROCEDURE PK-LF, Model Number DYNJ0604508R; s) CARDIAC CATH PACK-LF, Model Number DYNJ0842644F; t) PEDIATRIC CATH PACK-LF, Model Number DYNJ0843244K; u) ANGIOGRAPHY PACK-LF, Model Number DYNJ0854485V; v) CARDIAC CATH PACK-LF, Model Number DYNJ0855138P; w) CARDIAC CATH PACK-LF, Model Number DYNJ0855138Q; x) IR PICC PACK-LF, Model Number DYNJ0950839C; y) SPECIAL PROCEDURES, Model Number DYNJ23288C; z) ANGIO TRAY, Model Number DYNJ23438M; aa) ADULT CARDIAC CATH PACK, Model Number DYNJ23455K; bb) ADULT CARDIAC CATH PACK, Model Number DYNJ23455L; cc) ADULT CARDIAC CATH PACK, Model Number DYNJ23455M; dd) ADULT CARDIAC CATH PACK, Model Number DYNJ23455N; ee) STENT PACK-LF, Model Number DYNJ27613K; ff) CATH I W/ ANGIO DRAPE, Model Number DYNJ33709F; gg) JUGULAR PACK, Model Number DYNJ35164C; hh) ANGIO DRAPE PACK RADIOLOGY-LF, Model Number DYNJ35993F; ii) ANGIO DRAPE II-LF, Model Number DYNJ35994C; jj) ANGIO/PICC PACK, Model Number DYNJ36049A; kk) ISSAQUA CATH/IR PACK, Model Number DYNJ36738G; ll) IR PACK, Model Number DYNJ36752B; mm) ARTERIOGRAM TRAY-LF, Model Number DYNJ36807C; nn) SPECIAL PROCEDURE PACK, Model Number DYNJ38314G; oo) MINOR SPECIAL PROCEDURE PACK, Model Number DYNJ38326G; pp) CARDIAC CATH PACK, Model Number DYNJ38866F; qq) INTERVENTIONAL RAD L J-LF, Model Number DYNJ40215B; rr) ABLATION PACK, Model Number DYNJ40629C; ss) CATH LAB PACK, Model Number DYNJ40926A; tt) RADIOLOGY PACK, Model Number DYNJ41190; uu) TV IR PACK-LF, Model Number DYNJ41562F; vv) CUSTOM ANGIO TRAY, Model Number DYNJ41649G; ww) CARDIAC CATH DRAPE PACK, Model Number DYNJ41700A; xx) IR PACK, Model Number DYNJ41989G; yy) INTERVENTIONAL RADIOLOGY PACK, Model Number DYNJ42231C; zz) ANGIO PACK, Model Number DYNJ42903C; aaa) ANGIO PACK, Model Number DYNJ42903D; bbb) CARDIAC CATH PACK-LF, Model Number DYNJ42996C; ccc) DIALYSIS TRAY, Model Number DYNJ43060B; ddd) ANGIOPLASTY PACK-LF, Model Number DYNJ43203G; eee) ARTERIOGRAM PACK, Model Number DYNJ43261J; fff) CATH LAB RIGHT HEART PACK, Model Number DYNJ43315L; ggg) ANGIO CATH COMBINED PACK, Model Number DYNJ43609P; hhh) ANGIO CATH COMBINED PACK, Model Number DYNJ43609R; iii) ANGIO CATH COMBINED PACK, Model Number DYNJ43609S; jjj) ANGIO PACK, Model Number DYNJ43661C; kkk) ABLATION EP PACK, Model Number DYNJ43851B; lll) PK, RADIOLOGY, Model Number DYNJ43894B; mmm) PK, RADIOLOGY, Model Number DYNJ44087A; nnn) ANGIOGRAPHY PACK, Model Number DYNJ44293F; ooo) ANGIO DRAPE PACK, Model Number DYNJ44320G; ppp) ANGIO DRAPE PACK, Model Number DYNJ44320I; qqq) ANGIO DRAPE PACK, Model Number DYNJ44320J; rrr) FEMORAL ANGIO PACK, Model Number DYNJ44334M; sss) FEMORAL ANGIO PACK, Model Number DYNJ44334N; ttt) RADIOLOGY PACK, Model Number DYNJ44524F; uuu) ANGIO PACK, Model Number DYNJ44642B; vvv) ANGIOPLASTY PACK, Model Number DYNJ44700J; www) ANGIO PACK, Model Number DYNJ44993J; xxx) ANGIOGRAPHY PACK, Model Number DYNJ45059B; yyy) PERCUTANEOUS PACK, Model Number D
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·July 26, 2023
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a. NORTON CHILDRENS CATH LAB-LF, Model Number 00-401185Q; b. PERCUTANEOUS VASCULAR CDS, Model Number CDS840487I; c. BAPTIST SOUTH OPEN HEART CV PK, Model Number CDS983147I; d. ENDOVASCULAR CDS, Model Number CDS983394I; e. ENDOVASCULAR CDS, Model Number CDS983394J; f. ENDOVASCULAR CDS, Model Number CDS983394K; g. OPEN HEART CDS, Model Number CDS983513F; h. OPEN HEART ANESTHESIA PACK, Model Number CDS983849D; i. OPEN HEART ANESTHESIA PACK, Model Number CDS983849F; j. VNUS, Model Number CDS984292I; k. OPEN HEART CDS, Model Number CDS984355G; l. BEDSIDE PICC CDS, Model Number CDS984642; m. VASCULAR, Model Number CDS984764G; n. OPEN HEART A, Model Number CDS985105O; o. VASCULAR, Model Number CDS985355D; p. VASCULAR, Model Number CDS985355F; q. ECMO KIT, Model Number CVI4955; r. KIT CARDIAC CSICU ADULT ECMO, Model Number DYKMBNDL21; s. VASCULAR ACCESS PROCEDURE KIT, Model Number DYNDA2526; t. ARTERIAL/VENOUS ACCESS TRAY, Model Number DYNDC3038; u. DIAGNOSTIC RADIO HOLLAN PK-LF, Model Number DYNJ0037939B; v. OPEN HEART CABG PACK-LF, Model Number DYNJ0149567C; w. VASCULAR ANGIO PACK-LF, Model Number DYNJ0201109AJ; x. OPEN HEART PACK-LF, Model Number DYNJ0371669N; y. CABG PACK, Model Number DYNJ0408782AA; z. CARDIAC EP PACK-LF, Model Number DYNJ0429185K; aa. CARDIAC EP PACK-LF, Model Number DYNJ0429185M; bb. OPEN HEART A & B PACK, Model Number DYNJ0450131AI; cc. VASCULAR PACK-LF, Model Number DYNJ0493141J; dd. RIGHT HEART PACK-LF, Model Number DYNJ0565558U; ee. ENDO VASCULAR PACK-LF, Model Number DYNJ0676055N; ff. LOWER ENDO VASCULAR PACK, Model Number DYNJ0678934G; gg. ENDOVASCULAR PACK, Model Number DYNJ0678934I; hh. RR-NEURO DBS HEAD PACK-LF, Model Number DYNJ0785736J; ii. ELECTROPHYSIOLOGY PACK-LF, Model Number DYNJ0842825D; jj. VASCULAR PACK-LF, Model Number DYNJ0871182AC; kk. ELECTROPHYSIOLOGY TRAY-LF, Model Number DYNJ09878D; ll. EP PACK, Model Number DYNJ16618J; mm. EP PACK, Model Number DYNJ16618K; nn. ST MARY'S STL OPEN HRT SUPPLY, Model Number DYNJ20031C; oo. VEIN PACK, Model Number DYNJ21949J; pp. VASCULAR PACK, Model Number DYNJ22350L; qq. EP PACK, Model Number DYNJ23456K; rr. ANGIO-VASCULAR, Model Number DYNJ24272C; ss. EP ANGIO PACK, Model Number DYNJ25749S; tt. C.V. MINOR PACK, Model Number DYNJ28849B; uu. EP TRAY, Model Number DYNJ31928D; vv. PACER PACK, Model Number DYNJ34844C; ww. ADULT CARDIO TRAY, Model Number DYNJ35495G; xx. PEDIATRIC CARDIO CATH PACK, Model Number DYNJ35578G; yy. CARDIO B PACK, Model Number DYNJ36052O; zz. VASCULAR ENDO LASER PK, Model Number DYNJ37445I; aaa. VEIN PROCEDURE PACK, Model Number DYNJ38264D; bbb. HMT VEIN PACK, Model Number DYNJ38756B; ccc. LASER AND VEIN PACK, Model Number DYNJ38995C; ddd. VEIN CLOSURE PACK, Model Number DYNJ39408F; eee. CAROTID PACK, Model Number DYNJ39488G; fff. VEIN PACK, Model Number DYNJ39889; ggg. CVL CUSTOM PACK, Model Number DYNJ40067G; hhh. AV GRAFT-LF, Model Number DYNJ40077F; iii. VASCULAR-LF, Model Number DYNJ40108I; jjj. INTERVENTIONAL RAD L J-LF, Model Number DYNJ40215C; kkk. RIGHT HEART TRAY, Model Number DYNJ40379D; lll. LINE PACK, Model Number DYNJ41100C; mmm. CARDIAC CATH PACK, Model Number DYNJ41195D; nnn. VEIN PK, Model Number DYNJ42976; ooo. VEIN CLOSURE PACK, Model Number DYNJ43085A; ppp. PROCEDURE PACK, Model Number DYNJ43922; qqq. PK, RADIOLOGY-PORTSMOUTH, Model Number DYNJ44087B; rrr. PACEMAKER PACK, Model Number DYNJ44345F; sss. PACEMAKER PACK, Model Number DYNJ44345G; ttt. VENOUS ACCESS PACK, Model Number DYNJ44421D; uuu. VEIN CLOSURE TRAY, Model Number DYNJ44737B; vvv. ENDO LASER ABLATION PK-LF, Model Number DYNJ44808G; www. PK, OPEN HEART, Model Number DYNJ45074C; xxx. VASCULAR PACK, Model Number DYNJ46246A; yyy. CVP PACK, Model Number DYNJ46359D; zzz. INTERVENTIONAL RADIOLOGY PACK, Model Number DYNJ47138B; aaaa. EP DRAPE PACK-LF, Model Number DYNJ47645C; bbbb. RF OPEN HEAR
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·July 26, 2023
Medline procedural kits labeled as: 1) ALL DOC EYE PACK, Pack Number DYNJ51654A ; 2) ASC CATARACT PACK , Pack Number DYNJ0855117O ; 3) BAI , Pack Number DYNJ53847D ; 4) BASIC EYE PACK, Pack Number DYNJ83699A ; 5) BASIC EYE PACK, Pack Number DYNJ81805; 6) BASIC EYE PACK, Pack Number DYNJ83699A ; 7) BYERS CATARACT, Pack Number DYNJ67344; 8) BYERS CATARACT, Pack Number DYNJ67344H ; 9) CATARACT, Pack Number DYNJ44544B ; 10) CATARACT, Pack Number DYNJ54713C ; 11) CATARACT CDS , Pack Number CDS983804F ; 12) CATARACT CDS, Pack Number CDS983804F ; 13) CATARACT DR MALONE PACK , Pack Number DYNJ51590A ; 14) CATARACT DR MULROONEY PACK, Pack Number DYNJ51595A ; 15) CATARACT DR STEVENS PACK, Pack Number DYNJ51593C ; 16) CATARACT L J, Pack Number DYNJ40056A ; 17) CATARACT PACK, Pack Number CMPJ03235C ; 18) CATARACT PACK, Pack Number DYNJ80316A ; 19) CATARACT PACK, Pack Number VAL011CTASF; 20) CATARACT PACK , Pack Number CMPJ03235C ; 21) CATARACT PACK , Pack Number DYNJ31020K ; 22) CATARACT PACK , Pack Number DYNJ31020L ; 23) CATARACT PACK , Pack Number DYNJ54790D ; 24) CATARACT PACK , Pack Number DYNJ64962; 25) CATARACT PACK , Pack Number DYNJ80316; 26) CATARACT PACK , Pack Number DYNJ80316A ; 27) CATARACT PACK , Pack Number DYNJ80487A ; 28) CATARACT PACK , Pack Number DYNJ80487B ; 29) CATARACT PACK , Pack Number DYNJ80487C ; 30) CATARACT PACK , Pack Number DYNJ80487F ; 31) CATARACT PACK , Pack Number DYNJ84265A ; 32) CATARACT PACK , Pack Number DYNJ85332; 33) CATARACT PACK , Pack Number LYN042CPFEG; 34) CATARACT PACK , Pack Number VAL011CTASF; 35) CATARACT PACK , Pack Number DYNJ43048K ; 36) CATARACT PACK , Pack Number DYNJ52649D ; 37) CATARACT PACK , Pack Number DYNJ52649F ; 38) CATARACT PACK , Pack Number DYNJ55682D ; 39) CATARACT PACK , Pack Number DYNJ63284A ; 40) CATARACT PACK , Pack Number DYNJ63284B ; 41) CATARACT PACK , Pack Number DYNJ66410B ; 42) CATARACT PACK , Pack Number DYNJ85042; 43) CATARACT PACK , Pack Number DYNJ68836B ; 44) CATARACT PACK - GB, Pack Number DYNJ54790F ; 45) CATARACT PACK LUTHER HOSPITAL , Pack Number DYNJ61699D ; 46) CATARACT PACK WITH NO TUB , Pack Number DYNJ80232; 47) CATARACT PACK WITH NO TUB , Pack Number DYNJ80232H ; 48) CATARACT PACK-LF, Pack Number DYNJ42830D ; 49) CATARACT PACK-LF, Pack Number DYNJ0200004B ; 50) CATARACT PACK-LF, Pack Number DYNJ36100C ; 51) CATARACT TRAY , Pack Number DYNJ44356I ; 52) CATARACT TRAY , Pack Number DYNJ44356J ; 53) CATARACT TRAY , Pack Number DYNJ62410A ; 54) COVENANT RETINAL TRAY , Pack Number EYT102K; 55) CUSTOM EYE TRAY #1, Pack Number DYNJ66003D ; 56) CUSTOM EYE TRAY #1, Pack Number DYNJ66003C ; 57) CUSTOM EYE TRAY #1, Pack Number DYNJ66003D ; 58) CUSTOM EYE TRAY #2 , Pack Number DYNJ66004B ; 59) CUSTOM EYE TRAY #2, Pack Number DYNJ66004A ; 60) CUSTOM EYE TRAY #2, Pack Number DYNJ66004B ; 61) DDD VITRECTOMY PACK-LF, Pack Number DYNJ19973S ; 62) DR FLOOD EYE PACK , Pack Number DYNJ57258G ; 63) DR. OSTER GROSSER EYE PACK, Pack Number DYNJ44671C ; 64) DR. OSTER GROSSER EYE PACK, Pack Number DYNJ44671D ; 65) EYE , Pack Number DYNJ0559863K ; 66) EYE BCS PACK, Pack Number DYNJ37682J ; 67) EYE BCS PACK, Pack Number DYNJ37682K ; 68) EYE CATARACT (BASIC EYE), Pack Number DYNJ63272B ; 69) EYE INJECTION KIT , Pack Number MNS13080 ; 70) EYE MUSCLE PACK , Pack Number DYNJ66022A ; 71) EYE MUSCLE TRAY FFX , Pack Number DYNJ63638A ; 72) EYE PACK, Pack Number DYNJ40135C ; 73) EYE PACK, Pack Number DYNJ55484A ; 74) EYE PACK, Pack Number DYNJ60960A ; 75) EYE PACK, Pack Number DYNJ67973B ; 76) EYE PACK, Pack Number DYNJ83799C ; 77) EYE PACK, Pack Number VAL013EPWEC; 78) EYE PACK, Pack Number VAL038BSCLC; 79) EYE PACK, Pack Number DYNJ56293D ; 80) EYE PACK, Pack Number DYNJ64051C ; 81) EYE PACK, Pack Number CMPJ06528F ; 82) EYE PACK, Pack Number DYNJ38400I ; 83) EYE PACK, Pack Number DYNJ38400J ; 84) EYE PACK, Pack Number DYNJ64284C ; 85) EYE PACK, Pack Number DYNJ64284D ; 86) EYE PACK, Pack Numbe
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 4, 2024
Sterile Procedural Trays, labeled as the following: a. LAPAROTOMY CDS-LF b. LAPAROSCOPY CDS-LF c. BASIC LAPAROSCOPY CDS d. LAPAROSCOPY CDS-LF e. GENERAL LAPAROSCOPY PROCEDURE f. LAP CHOLE CDS g. COLO-RECTAL CDS-LF h. MAJOR PROCEDURE-LF i. HYPOSPADIUS CDS j. LAPAROSCOPY-GENERAL k. LAP CHOLE CDS l. GENERAL LAPAROSCOPY CDS m. MINOR PROCEDURE CDS n. MAJOR CDS o. HERNIA CDS p. MINOR CDS q. MAJOR PROCEDURE CDS r. LAP GASTRIC BYPASS CDS UCC s. GENERAL LAPAROSCOPY CDS t. LAP CHOLE CDS u. CUH MAJOR PROCEDURE CDS v. LAPAROSCOPIC CDS-LF w. GENERAL LAPAROSCOPY CDS-LF x. MAJOR ABDOMINAL CDS y. LAP CHOLE CDS z. GENERAL SURGERY CDS aa. MAJOR ABDOMINAL/GENERAL-LF bb. LAP CHOLE/LAPAROSCOPIC ABD-LF cc. GENERAL LAPAROSCOPY CDS dd. LAPAROSCOPY CDS ee. GENERAL LAPAROSCOPY CDS ff. LAP CHOLE CDS UCC-LF gg. GENERAL LAPAROSCOPY CDS hh. LAPAROSCOPY CDS ii. BARIATRIC PROCEDURE jj. MINOR SURGERY CDS kk. LAP CHOLE CDS ll. ACH MINOR PROCEDURE mm. ACH MINOR PROCEDURE nn. ACH MAJOR ABDOMINAL oo. GENERAL LAPAROSCOPY pp. LAP COLECTOMY PACK-LF qq. MINOR PROCEDURE PACK-LF rr. OPERATIVE LAPAROSCOPY PACK-LF ss. LAP CHOLE PACK-LF tt. MAJOR PROCEDURE PACK-LF uu. GYN MAJOR ABDOMINAL PACK-LF vv. MAJOR ABDOMINAL HARPER PACK-LF ww. LAPAROTOMY PACK-LF xx. LAPAROTOMY PACK-LF yy. MINOR PACK-LF zz. MINOR PROCEDURE PACK-LF aaa. LAP CHOLE PACK bbb. LAP APPY PACK ccc. LAP APPY PACK ddd. OPEN HERNIA APPY PACK eee. LAP CHOLE PACK-LF fff. LAP CHOLE PACK-LF ggg. LAPAROSCOPY PACK-LF hhh. MINOR PACK-LF iii. LAPAROTOMY BASIC PACK-LF jjj. LAP CHOLE PACK-LF kkk. MINOR PACK-LF lll. LAPAROSCOPIC - UNIV mmm. KIDNEY - UNIV nnn. LAP CHOLE PACK-LF ooo. LASER LAP PACK ppp. LAP CHOLE PACK-LF qqq. MAJOR LAPAROTOMY PACK-LF rrr. LAP CHOLE PACK-LF sss. MINOR PACK-LF ttt. MAJOR ABDOMINAL PACK-LF uuu. DAVINCI PACK-LF vvv. LAP CHOLE PACK www. LAPAROSCOPY PACK-GYN xxx. LAP CHOLE PACK yyy. MINOR PACK zzz. LAP CHOLE PACK-LF aaaa. MAJOR PACK bbbb. LAP CHOLE PACK-LF cccc. LAPAROSCOPY PACK-LF dddd. LAPAROSCOPY PACK-LF eeee. MINOR PACK-LF ffff. LAP CHOLE III-LF gggg. ROBOTICS PACK-LF hhhh. MINOR PACK iiii. PELVIC LAPAROSCOPY PACK-LF jjjj. LAP CHOLE PACK-LF kkkk. UNIVERSAL LAPAROSCOPY PACK-LF llll. LAPAROSCOPY PACK mmmm. LAPAROTOMY PACK-LF nnnn. LAPCHOLE II PACK-LF oooo. LAP CHOLE PACK-LF pppp. MINOR PACK-LF qqqq. MAJOR LAP PACK-LF rrrr. MINOR PROCEDURE CUSTOM PACK-LF ssss. MINOR PACK-LF tttt. LAPAROSCOPY PACK-LF uuuu. MONTEFIORE MVH LAPAROTOMY PACK vvvv. MINOR PACK-LF wwww. LAPAROSCOPY PK/ALTAMONTE xxxx. LAPAROSCOPY PK yyyy. LAP CHOLE PACK-LF zzzz. PPM-ICD PACK-LF aaaaa. STANDARD PACK-LF bbbbb. LAP CHOLE PACK ccccc. LAP TRAY-LF ddddd. MINOR PACK eeeee. BARIATRIC PACK #117-RF fffff. GENERAL LAPAROSCOPY PACK ggggg. TORNETTA ACETABULUM/PE PK hhhhh. MLD PACK iiiii. LAP CHOLE TRAY-LF jjjjj. SET UP PACK-LF kkkkk. LAPAROSCOPY PACK-LF lllll. MAJOR LAPAROTOMY PACK mmmmm. MVFF/FIBU #54-RF nnnnn. MAJOR GENERAL PACK ooooo. LAPAROSCOPY PACK ppppp. MINOR PACK-LF qqqqq. LAP CHOLE TRAY rrrrr. MINOR OPEN-RF-LF sssss. LAPAROSCOPY-RF-LF ttttt. MAJOR OPEN-RF-LF uuuuu. MONTEFIORE MVH MINOR PACK vvvvv. GLENNON GENERAL MAJOR PACK-LF wwwww. LAP CHOLE PACK xxxxx. MINOR PACK-LF yyyyy. MAJOR SET UP PACK-LF zzzzz. SCC RECTAL PACK aaaaaa. MINI LAPAROTOMY #16-RF bbbbbb. LAP CHOLE PACK cccccc. LAPAROSCOPY TRAY SC-LF dddddd. MINOR PACK eeeeee. LAP CHOLE PACK ffffff. SET UP PACK gggggg. LAPAROSCOPY PACK-LF hhhhhh. GENERAL LAPAROSCOPY PACK iiiiii. MAJOR ABDOMINAL PACK jjjjjj. OSC MINOR PACK-LF kkkkkk. MINOR SURGERY PACK llllll. BASIC LAPAROTOMY mmmmmm. GENERAL RECTAL PACK-LF nnnnnn. LAP CHOLE PACK-LF oooooo. LAP CHOLE PACK pppppp. LAPAROTOMY PK qqqqqq. LAPAROSCOPIC GALLBLADDER PACK rrrrrr. LAP CHOLE ssssss. LAPAROSCOPY tttttt. LAPAROTOMY uuuuuu. MINOR PACK vvvvvv. MINOR PACK wwwwww. MAJOR PACK xxxxxx. MINOR PACK yyyyyy. PEDIATRIC LAP PACK zzzzzz. MINOR PROCEDURE PACK-LF aaaaaaa. LAPAROSCOPY PACK bbbbbbb. LAPAROSCOPY PACK-LF ccccccc. PEDIATRIC LAP PACK-LF ddddddd. MINOR PACK-LF eeeeeee. MINOR ABDOMINAL PROCEDURPK-LF fffffff. GENERAL LAPAROS
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·February 15, 2023