23 results
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13ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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Sterile Procedural Trays, labeled as the following: a. ENDOSCOPY-LF b. SEPTO/ENDO
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·February 15, 2023
Sterile Procedural Trays, labeled as the following: a. MINOR/BREAST BIOPSY-LF b. BREAST BIOPSY-LF
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·February 15, 2023
Sterile Procedural Tray, labeled as the following: a. PAIN SERVICE PACK-LF; b. LOCAL BASIC
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·February 15, 2023
Sterile Procedural Trays, labeled as the following: a. MAJOR CDS-LF b. BURN PACK-LF c. BURN PACK d. SMALL BURN
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·February 15, 2023
Sterile Procedural Trays, labeled as the following: a. ORAL SURGERY PACK-LF b. EXTRACTION PACK c. ORAL SURGERY PACK d. DENTAL MINOR PACK e. ORAL
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·February 15, 2023
Sterile Procedural Trays, labeled as the following: a. GYN LAPAROTOMY HARPER PACK-LF b. OB GYN LAP PACK-LF c. VAGINAL HYSTERECTOMY PACK d. DELTA PACK e. MAJOR VAGINAL-LF f. GYN LAPAROSCOPY II
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·February 15, 2023
Sterile Procedural Trays, labeled as the following: a. BREAST BIOPSY PACK-LF b. BREAST BIOPSY PACK c. LAPAROTOMY PACK d. BREAST PACK e. SOFT TISSUE PACK f. HEMORRHOID PACK g. RECTAL h. BREAST i. BREAST
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·February 15, 2023
Sterile Procedural Trays, labeled as the following: a. CARDIAC CATH PACK-LF; b. ANGIOGRAPHY-NS-LF; c. EP BASIC SET UP PACK; d. IMPLANT PACK-LF; e. PORT PACEMAKER INSERTION PACK; f. OPEN HEART PACK; g. LAP BASIN TRAY; h. ANGIO ACCESS; i. ANGIO
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·February 15, 2023
Sterile Procedural Trays, labeled as the following: a. BASIC EYE PACK-LF b. VITRECTOMY PACK-LF c. EYE PACK-EAST-LF d. OSC OCULAR PLASTIC PACK-LF e. EYE PACK f. OCULOPLASTIC PACK g. EYE PLASTIC PACK h. PLASTIC EYE PACK i. DR H BLEPH PACK j. BLEPH PACK k. OPHTHALMOLOGY PACK l. OCULOPLASTIC PACK m. BLEPH PACK n. EYE PACK o. OCULAR PLASTIC PACK p. OCULOPLASTIC PACK
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·February 15, 2023
Sterile Procedural Trays, labeled as the following: a. KNEE ARTHROSCOPY CDS-LF b. ARTHROSCOPY CDS c. ARTHROSCOPY LV - EDOC PACK-LF d. ARTHROSCOPY PACK-LF e. ARTHROSCOPY PACK f. ARTHRO PACK-LF g. ARTHROSCOPY PACK-LF h. ARTHROSCOPY PACK-LF i. ARTHROSCOPY KNEE TRAY-LF j. ARTHROSCOPY PACK-LF k. ARTHROSCOPY BASIN PACK-LF l. ARTHROTOMY PACK-LF m. ARTHROSCOPY PACK-LF n. ARTHROSCOPY PACK o. ARTHROSCOPY PACK p. ARTHROSCOPY PACK q. ARTHROSCOPY PACK - LF r. SC ARTHROSCOPY PACK s. ARTHROSCOPY PACK-LF t. ARTHROSCOPY PACK u. ARTHROSCOPY PACK v. ARTHROSCOPY PACK w. OSC ARTHROSCOPY PK-LF x. ARTHROSCOPY PACK y. ARTHROSCOPY PACK z. ARTHROSCOPY PACK aa. ARTHROSCOPY PACK bb. ARTHROSCOPY PACK cc. KNEE ARTHROSCOPY PACK dd. KNEE ARTHROSCOPY PACK ee. SHOULDER ARTHROSCOPY PACK ff. SHOULDER ARTHROSCOPY gg. ARTHROSCOPY PACK hh. ARTHROSCOPY PACK ii. ARTHROSCOPY PACK jj. ARTHROSCOPY PACK kk. ARTHROSCOPY PACK ll. ARTHROSCOPY PACK-LF mm. ARTHROSCOPY KNEE nn. ARTHROSCOPY PACK oo. HIP ARTHROSCOPY PACK pp. ARTHROSCOPY PACK qq. MG NS KNEE ARTHROSCOPY PACK rr. KNEE ARTHROSCOPY PACK ss. ARTHROSCOPY PACK tt. ARTHROSCOPY-LF uu. ARTHROSCOPY KIT vv. SHOULDER ARTHROSCOPY ww. KNEE ARTHROSCOPY xx. ARTHROSCOPY PACK
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·February 15, 2023
Sterile Procedural Trays, labeled as the following: a. GYN-URO LAPSCP CDS-LF b. ROBOTIC CDS c. GYN LAPAROSCOPY CDS-LF d. GYN LAPAROSCOPY e. GYN LAPAROSCOPY CDS f. UNIVERSAL ROBOTIC ORLANDO g. GYN ROBOTIC CDS h. GYN LAPAROSCOPY CDS-1 i. CUH GYN LAPAROSCOPY CDS j. CUH GEN/GYN ROBOTIC CDS k. LAVH CDS-LF l. GYN LAPAROSCOPY CDS-LF m. GYN LAPAROSCOPY CDS UCC-LF n. DAY SURG GYN LAP CDS o. GYN LAPAROSCOPY CDS p. DAVINCI HYSTERECTOMY CDS q. GYN LAP/ROBOTIC r. DAVINCI PACK-LF s. DAVINCI PACK-LF t. GYN LAPAROSCOPY PACK-LF u. ROBOTIC PACK v. GYN LAP - UNIV w. BASIC LAVH PACK x. GYN/LAPAROSCOPY PACK-LF y. LAPAROSCOPIC GYN PACK-LF z. DAVINCI PACK-LF aa. SCC GYN LAPAROSCOPY PACK bb. URO GYN PACK-LF cc. GYN LAPAROSCOPY PACK dd. TUBAL PACK ee. GYN LAP PACK-LF ff. LAVH PACK gg. GYN LAPAROSCOPY-LF hh. LAVH PACK ii. PK-GYN-LAPAROSCOPY jj. MAJOR LAP PACK 2-LF kk. TUBAL PACK ll. GYN LAPAROSCOPY PACK-LF mm. PK, ROBOTICS-GYN nn. SVMMC GEN ROBOTIC PACK oo. SVMMC GYN ROBOTIC PACK pp. PACK, GYN-D&C qq. DA VINCI PROSTATE/COLPOPEXY rr. ROBOT PACK ss. PK, GYN-LAPAROSCOPY tt. LAPAROSCOPIC GYN PACK uu. DAVINCI PACK-RFD vv. GYN ROBOTIC PACK ww. LAVH PACK xx. ST. ANNE'S MULTI PORT PACK yy. LAVH PACK zz. SOUTH SC RFT GYN LAP PACK aaa. GYN LAPAROSCOPY PACK bbb. LITHOTOMY PENILE PACK ccc. DAVINCI GENERAL PACK ddd. DAVINCI GYN PACK eee. DAVINCI GYN PACK fff. ROBOTIC PROSTATE PACK ggg. GYN ROBOTIC PACK-LF hhh. SCRIPPS SW ROBOTIC PACK iii. GYN LITHOTOMY PACK jjj. GYN LAPAROSCOPY PACK kkk. DEACONESS PELVIC LAP PACK lll. WOMENS ROBOT PACK mmm. GYN LAPAROSCOPY PACK-LF nnn. MAJOR GYN PACK ooo. GYN LAPAROSCOPY PACK ppp. TUBAL PACK-LF qqq. PK, GYN-LAPAROSCOPY rrr. LAVH PACK sss. LAPAROTOMY PACK ttt. URO/GEN ROBOTIC PACK uuu. BASIC ROBOTIC PACK vvv. LAPAROSCOPIC GYN PACK www. PK, ROBOTICS-GYN xxx. PQ CHG CTRY GYN LAP PK yyy. GYN DAVINCI PACK zzz. ROBOT GYN SHARED aaaa. PK, ROBOTICS-GEN bbbb. DAVINCI PACK cccc. ROBOTIC GYN PACK dddd. ROBOTICS PACK eeee. PK- ROBOTICS ffff. GYN LAPAROSCOPY gggg. GU ROBOTIC PACK hhhh. GYN PACK iiii. BASIC GYN PACK jjjj. BWH GYN ROBOTICS PACK kkkk. BWH GU ROBOTICS PACK llll. URO GYN PACK mmmm. GYN LAP PACK nnnn. GYN LAPAROSCOPY oooo. ROBOTIC pppp. GYN ROBOTIC qqqq. CV ROBOTIC SET UP rrrr. GYN LAPAROSCOPY ssss. ROBOTIC LAVH tttt. ROBOTIC LAP CHOLE uuuu. GYN LAPAROSCOPY vvvv. GYN LAPAROSCOPY wwww. GYN ROBOTIC xxxx. GYN ENDOSCOPY-LF yyyy. GYN LAPAROSCOPY zzzz. LAP ROBOTIC aaaaa. TUBAL LIGATION CDS bbbbb. GYN LAPAROSCOPY ccccc. ROBOTIC GYN & GU ddddd. ROBOTIC eeeee. GYN LAPAROSCOPY fffff. ROBOT GYN ggggg. GYN LAPAROSCOPY hhhhh. FHWC ROBOTIC iiiii. GYN LAPAROSCOPY jjjjj. GYN LAPAROSCOPY kkkkk. ROBOTIC lllll. PELVISCOPY mmmmm. GENERAL ROBOT-TCN nnnnn. ROBOTICS ooooo. CVOR ROBOT ppppp. GU-GEN ROBOTIC qqqqq. FLOYD LAP GYN rrrrr. GYN ROBOTIC sssss. GYN LAPAROSCOPY CDS ttttt. LAP TUBAL uuuuu. DAVINCI GENERAL vvvvv. DAVINCI LOW ANTERIOR RESECTION wwwww. GYN xxxxx. PELVISCOPY PACK yyyyy. GYN LAPAROSCOPY STD PACK-LF zzzzz. LAP GYN PACK-LF
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·February 15, 2023
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
Sterile Procedural Trays, labeled as the following: a. EAR CDS-LF b. SINUS CDS-1 c. ZALE FESS CDS d. ZALE OTOLOGY CDS e. ZALE HEAD & NECK CDS f. CUH PARA/THYROIDECTOMY CDS g. CAM ENDOSCOPIC SINUS/SEPTO CDS h. HEAD AND NECK CDS i. HEAD AND NECK CDS-LF j. NASAL k. ENT SET UP CDS l. MINOR ENT SINUS PACK-LF m. MAJOR EAR PACK-LF n. THORACOTOMY HARPER PACK-LF o. FESS NSR PACK-LF p. ENT BASIC PACK-LF q. HEAD & NECK-LF r. ENT PACK-LF s. SINOSCOPY-LF t. MAJOR HEAD/NECK PACK-LF u. NECK PACK v. HEAD & NECK PACK w. HEAD & NECK TRAY x. ENT LAW PACK-LF y. ENT PACK z. NECK PACK aa. NASAL PACK bb. ENT PACK cc. FREE FLAP PACK-LF dd. TYMPANO MASTOID ee. MINOR HEAD & NECK #40-RF ff. EAR PACK gg. E.N.T. TRAY hh. EAR PACK-LF ii. BASIC ENT PACK-LF jj. PLASTIC HEAD & NECK PACK kk. EAR TRAY #10-RF ll. HEAD & NECK ENT PACK-RF-LF mm. ENT PACK nn. ENT PACK-LF oo. NASAL/SEPTO PACK pp. OSC FACE LIFT PK qq. RRMC NASAL PACK rr. ENT PACK ss. HENRYS ENT PACK tt. ENT uu. FACE AND NASAL PACK vv. NASAL PACK ww. ENT PACK xx. SINUS ENDOSCOPY-LF yy. OSC NASAL-NOSE PACK-LF zz. ENT PACK aaa. FES PACK - LF bbb. HEAD AND NECK PACK ccc. SCRIPPS SW ENT PACK ddd. SCRIPPS SW EAR PACK-LF eee. HL ENT PACK fff. CAROTID ENDARTECTOMY PK ggg. EAR PACK hhh. ENT FREE FLAP iii. HEAD AND NECK PACK jjj. TRACH PACK kkk. HL EAR PACK lll. NASAL SINUS ENDO PK mmm. ENT PACK nnn. HEAD AND NECK PACK ooo. ENT PACK ppp. HEAD AND NECK PACK qqq. ASC HEAD & NECK PACK rrr. ENT PACK sss. DEACONESS HEAD AND NECK PACK ttt. ENT PACK uuu. BEC MOHS PACK vvv. PK,ENT-EAR www. SVMMC HEAD AND NECK PACK xxx. PK, ENT yyy. HEAD AND NECK PACK zzz. FESS PACK aaaa. PK,ENT-SINUS bbbb. NASAL/HEAD & NECK PACK cccc. ENT PACK dddd. ENT PACK eeee. MAJOR ENT PACK ffff. ENT NECK MMC PACK gggg. HEAD AND NECK PACK hhhh. HEAD AND NECK PACK iiii. HEAD AND NECK PACK jjjj. ORAL PACK kkkk. HMT THORACOSCOPY PACK llll. GU PACK mmmm. HEAD NECKPACK (HNSJC)227-LF nnnn. HEAD AND NECK PLUS I PACK oooo. NASAL PACK pppp. HEAD & NECK PACK-RFD-LF qqqq. ENT PACK rrrr. ENT/H&N PACK ssss. C-SECTION PACK tttt. ENT PACK uuuu. ENT PACK vvvv. ENT PACK wwww. NASAL ENT PACK xxxx. SINUS PACK yyyy. HEAD/NECK PACK zzzz. ENT PACK aaaaa. NASAL PACK bbbbb. FESS PACK ccccc. NASAL SEPTOPLASTY PACK ddddd. ENT PACK eeeee. HEAD&NECK fffff. EAR PACK-LF ggggg. HEAD AND NECK PACK-LF hhhhh. EAR BASIC PACK iiiii. HEAD AND NECK PACK jjjjj. ENT/SEPTO PACK kkkkk. ENT PACK lllll. HEAD & NECK PACK mmmmm. HEAD AND NECK PACK nnnnn. ENT PACK ooooo. ENT PACK-LF ppppp. ENT PACK-LF qqqqq. HL DR PETERS ENT PACK rrrrr. RHINO/SEPTO/FESS PACK sssss. HEAD & NECK ttttt. THYROID/PARATHYROID PACK uuuuu. HEAD AND NECK MINOR PACK vvvvv. PK,ENT wwwww. ENT PACK xxxxx. ENT PACK yyyyy. ENT PACK zzzzz. ENT NECK PACK aaaaaa. ENT PACK bbbbbb. NECK PACK cccccc. EAR TRAY dddddd. HEAD & NECK PACK eeeeee. HEAD & NECK PACK ffffff. MHPB HEAD AND NECK PACK gggggg. NASAL PACK hhhhhh. ENT PACK iiiiii. JHOC EAR TRAY jjjjjj. JHOC HEAD TRAY kkkkkk. ENT I llllll. ENT SHARED mmmmmm. ENT PACK nnnnnn. EENT SPLIT PACK-NO GPAD oooooo. ENT PACK pppppp. HEAD & NECK PACK qqqqqq. NASAL PACK rrrrrr. ENT PACK ssssss. ENT PACK tttttt. ENT PACK uuuuuu. ENT PACK vvvvvv. ENT PACK-LF wwwwww. ENT I-LF xxxxxx. MAJOR HEAD AND NECK PACK yyyyyy. HEAD AND NECK PACK zzzzzz. FACE AND NECK aaaaaaa. ENT PACK bbbbbbb. ENT PACK ccccccc. ENT BASIC PACK-LF ddddddd. ENT PACK-LF eeeeeee. PK, ENT-H&N fffffff. ENT PACK ggggggg. SPRINGS HEAD AND NECK PACK hhhhhhh. ENDO SINUS PACK iiiiiii. HEAD/NECK PACK jjjjjjj. ENT/SINUS PACK-LF kkkkkkk. ENT PACK lllllll. NASAL PACK mmmmmmm. ENT PACK nnnnnnn. ORAL PLASTIC FACIAL PACK ooooooo. ENT HEAD NECK PACK ppppppp. THYROIDECTOMY PACK qqqqqqq. MINOR ORL PACK rrrrrrr. EAR CUSTOM PACK sssssss. MG NS ENT PACK ttttttt. HEAD AND NECK PACK uuuuuuu. ENT PACK vvvvvvv. MAJOR ENT PACK wwwwwww. ENT xxxxxxx. NASAL EAR yyyyyyy. NASAL-LF zzzzzzz. LARGE ENT aaaaaaaa. EAR bbbbbbbb. HEAD AND NECK cccccccc. PAD ENT HEAD & NECK dddddddd. FHT CVOR TAVR eeeeeeee. MODULE NASAL NATALIE ffffffff. ENT-LF gggggggg. HEA
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·February 15, 2023
Focalyx Fusion
FDA Enforcement
Class II
·Ongoing·Focalyx Technologies, LLC.·February 11, 2026
Battery Mobile X-ray Unit EASY MOVING Model with telescopic column 3.1, model numbers: a. SM-20HF-Batt; b. SM-32HF-Batt; c. SM-40HF-Batt; d. SM-50HF-Batt; e. SM-40-HF-B-D-VIR; f. SM-20HF-B-D-KM (AeroDR X30); g. SM-32-HF-B-D-KM (AeroDR X30); h. SM-40HF-B-D-KM (AeroDR X30); i. SM-50HF-B-D-KM (AeroDR X30); j. MobileDiagnost wDR.
FDA Enforcement
Class II
·Ongoing·SEDECAL SA·May 8, 2024
Temporary Titanium Abutments
FDA Enforcement
Class II
·Ongoing·DDS Lab·February 12, 2025
BD Kiestra" ReadA; Catalog No.: 446948.
FDA Enforcement
Class II
·Ongoing·BD KIESTRA LAB AUTOMATION·April 8, 2026
ELI, Burdick and McKesson brand 280 Resting Electrocardiographs (ELI 280, MLBUR280 and BUR280), Model Numbers: ELI280-DDB-ADAAX, ELI280-BDB-ACAAX, ELI280-CAA-AAFAD, ELI280-BDB-BDFAX, ELI280-BCB-AAAAX, ELI280-DDB-ACAAX, ELI280-DBA-BAFAX, ELI280-DCB-AAAAX, ELI280-DBA-AAFBD, ELI280-AAA-AAEBX, ELI280-BBA-ADFBD, ELI280-DDB-ACFAX, MLBUR280-81X, ELI280-CAA-ACEBX, ELI280-AAA-AAHBX, ELI280-DDB-BDFAX, ELI280-CAA-AAFBT, ELI280-DCD-ADFAD, ELI280-DDB-AACBX, ELI280-JXX-BDFAX, ELI280-CAA-ADCBX, ELI280-BCB-AACBD, ELI280-LDX-ADFBX, ELI280-LDX-ADCBX, ELI280-BDD-ADFAD, ELI280-BDB-AAFBD, ELI280-BDB-ACCAD, ELI280-BDB-ADFAD, ELI280-LDX-ADFBD, ELI280-DDB-AAFBD, ELI280-DCB-ACFAD, ELI280-AAA-BAFAF, MLBUR280-W1X, ELI280-DCB-AAABX, ELI280-AAA-ACAAX, ELI280-ADA-ABFBX, ELI280-BCB-AAFBD, ELI280-BCB-AAFBX, ELI280-CEA-ADFBX, ELI280-CDA-ADABX, ELI280-BDB-AAABX, ELI280-DDB-ACFBD, ELI280-DDB-BCFAX, ELI280-ADA-ADCAX, ELI280-BDB-AACBX, ELI280-BCB-ACAAX, BUR280-81X, ELI280-DCB-AAFBG, ELI280-BDB-AAFBT, ELI280-DCB-AAFAD, ELI280-CAA-ADFBX, ELI280-BDB-AAFBG, ELI280-BDB-AAFBX, ELI280-DCA-ACAAX, ELI280-CAB-ACFBX, ELI280-ADA-ACFAX, ELI280-CAA-AAFAT, ELI280-CAA-ACFBD, ELI280-CDA-ADCBX, ELI280-AAA-ADCBX, ELI280-CAA-AAFBD, ELI280-DCB-BAFBT, ELI280-BBA-AAAAX, ELI280-BBA-AAFAD, ELI280-DBA-AAFAD, ELI280-DCB-AAFBT, ELI280-DBA-ADFAX, ELI280-BBA-AAFBD, MLBUR280-C1X, ELI280-BBA-ADFAX, ELI280-DDD-ADFAD, ELI280-DBA-AAFAX, MLBUR280-W1D, ELI280-BCB-AACBX, ELI280-DCB-AACBD, ELI280-LDX-ADFBG, ELI280-DCB-AACBX, ELI280-DBA-ADFBD, ELI280-DDB-AAFBG, ELI280-DBA-AAABD, ELI280-DCB-AAFBX, ELI280-AAA-AAFBT, MLBUR280-C1D, ELI280-AAB-ADAAX, ELI280-DDB-AAFBT, ELI280-CAA-AACBX, ELI280-CEB-ACFBX, ELI280-CAA-ABFAX, ELI280-DDB-AAFBX, ELI280-DBA-AAAAX, ELI280-BCB-AAFBG, ELI280-BFA-ADCBX, ELI280-LDX-ADABX, MLBUR280-81D, ELI280-BBA-ADFAD, ELI280-CAA-ADHAX, ELI280-CEB-ACFBD, ELI280-AAB-ADCAD, ELI280-BDB-AACBD, ELI280-LDX-ADCBD, ELI280-AAB-ACCBX, ELI280-AAA-ABFBX, ELI280-DAB-ADCAD, ELI280-AFB-ABCBX, ELI280-DCB-AACAX, ELI280-DEB-ACFBD, ELI280-ADA-ACAAX, ELI280-AAB-ADFAD, ELI280-DCB-AAFBD, ELI280-CAA-AAAAX, ELI280-BDB-ACCAX, ELI280-CAA-AAFBX, ELI280-DDB-AAABX, ELI280-DCB-ACAAX, ELI280-CAA-ADFBD, ELI280-CBB-ACCBX, ELI280-DDB-AACBD, ELI280-DDB-ACCAX, ELI280-A, ELI280-DFA-ADCBX, ELI280-BCA-AAAAX, ELI280-DDB-AAAAX, ELI280-E, ELI280-C, ELI280-AAA-AAFBD, ELI280-DFC-ADFAD, BUR280-C1X, ELI280-D, ELI280-BAA-ACCBD, ELI280-AAA-AAAAX, BUR280-W1X, ELI280-B, ELI280-BCB-AAABX, ELI280-BCB-AACAX, BUR280-W1D, ELI280-F, ELI280-BCB-AAFAD, ELI280-BCB-BAFAX, BUR280-81D
FDA Enforcement
Class II
·Ongoing·Welch Allyn Inc Mortara·October 13, 2021
Nice-En-Smooth Berry Burst, 4 oz., Manufactured by Meta Labs LLC, UPC 80604-8 Product Usage: Flavored lubricant water based, condom friendly jelly used to enhance or replace a womans natural lubrication.
FDA Enforcement
Class II
·Ongoing·Altasource LLC dba Meta Labs LLC·April 30, 2014
Amo-O Herbal Stimulator, 2 fl. oz. Manufactured by Meta Labs, Alpharetta, GA 30076, UPC Code 80702-1 Product Usage: The product is a nonprescription, topical gel that is used to enhance libido and stimulate orgasmic pleasure.
FDA Enforcement
Class II
·Ongoing·Altasource LLC dba Meta Labs LLC·April 30, 2014