8 results
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10ms
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Sources: EU EUDAMED, US FDA
Inion GRT Tack, drill bit and tack appl., 4x, Sterile. Is indicated for the surgical treatment of periodontal defects to aid in the regeneration and integration of tissue components in guided tissue regeneration procedures, for pre-implant and peri-implant surgery and for covering bone defects and empty sockets.
FDA Enforcement
Class II
·Terminated·Inion Ltd.·March 22, 2017
TomoTherapy Treatment System - Product Usage: used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue.
FDA Enforcement
Class II
·Terminated·Accuray Incorporated·January 13, 2021
TomoTherapy Treatment Delivery System with iDMS - Product Usage: used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue.
FDA Enforcement
Class II
·Terminated·Accuray Incorporated·January 13, 2021
AbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks 5 mm- -intended for fixation of prosthetic material to soft tissue in minimally invasive and open surgical hernia repair procedures Model ABSTACK30
FDA Enforcement
Class II
·Ongoing·Covidien LP·February 14, 2024
Titanium Tack Starter Kit, REF 400-270, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.
FDA Enforcement
Class II
·Terminated·BioHorizons Implant Systems Inc·December 26, 2012
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. 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
Sterile Procedural Trays, labeled as the following: a. BASIN SET-UP PACK b. LAP CHOLE CDS c. MAJOR CDS d. UROLOGY MINOR CDS e. UROLOGY MAJOR CDS f. SINGLE BASIC CDS g. ORGAN RECOVERY CDS h. GENERAL ABD CDS i. BURN CDS j. MINOR k. MAJOR VASCULAR l. BASIC CORE CDS m. ROBOTIC PROCEDURE n. MAJOR VASCULAR CDS o. PEDI LITHOTOMY p. MAJOR CDS-1 q. MINOR CDS-1 r. VASCULAR CDS-4 s. SEPTOPLASTY CDS t. DENTAL CDS u. MINOR GENERAL CDS v. CUH UROLOGY LITHOTOMY CDS w. CUH UROLOGY OPEN CDS x. CUH LIVER TRANSPLANT CDS y. THORACOTOMY CDS z. XI THORACIC ROBOTIC CDS aa. GENERAL CDS bb. THORACIC CDS cc. MINOR PROCEDURE dd. EXTREMITY CDS ee. DOUBLE BASIN CDS ff. PEDIATRIC gg. P.V.STARTER TRAY hh. CV PACK ii. MINOR GENERAL-LF jj. VASCULAR PACK-LF kk. UROLOGY PACK ll. MINOR LINEN PACK-LF mm. ABDOMINAL PACK-LF nn. MINOR SURGICAL SETUP PACK-LF oo. MINOR GENERAL PACK-LF pp. MAJOR ABDOMINAL PACK-LF qq. MINOR VASCULAR PACK-LF rr. MAJOR BASIN PACK-LF ss. DAVINCI PACK-LF tt. MINOR ENT HARPER PACK-LF uu. CHOM START UP PACK-LF vv. MINOR HARPER PACK-LF ww. MAJOR ENT HARPER PACK-LF xx. THROMBECTOMY HARPER PACK-LF yy. PENILE PROSTHESIS HARPER PK-LF zz. RECONSTRUCTIVE PACK-LF aaa. CUSTOM COLIC PACK bbb. MAJOR PACK ccc. ROBOTIC PACK ddd. MINOR PACK eee. MINOR PACK-LF fff. CT THORACIC PACK ggg. KIDNEY TRANSPLANT PACK-LF hhh. DAVINCI ROBOTIC PACK iii. MAJOR UNIVERSAL PACK-LF jjj. BASIC SETUP PACK-LF kkk. BASIC ABDOMINAL PACK-LF lll. PENILE IMPLANT PACK-LF mmm. VALVE UNIV OF CINN PACK-LF nnn. CABG UNIVERSITY HOSP PACK-LF ooo. AAA - UNIV ppp. LIVER TRANSPLNT UNIV CI PK-LF qqq. AV FISTULA PACK-LF rrr. MAJOR PACK-LF sss. MINOR SNGL BASIN PACK-LF ttt. MAJOR BASIN PACK-LF uuu. MAJOR PACK L-F vvv. PEDIATRIC PACK www. BASIC PACK-LF xxx. BASIC PACK-LF yyy. MAJOR PACK-LF zzz. MAJOR PACK aaaa. MINOR PACK bbbb. UPPER EXTREMITY PACK-LF cccc. MAJOR PACK-LF dddd. DR PALEY ILIZAROV PACK-LF eeee. MAJOR PACK ffff. BASIC PACK-LF gggg. MAJOR PACK hhhh. MAJOR LITHOTOMY PACK iiii. MAJOR LITHOTOMY PACK-LF jjjj. MAJOR PACK kkkk. MAJOR PACK llll. MAJOR LITHOTOMY PACK mmmm. AMC MINOR PACK-LF nnnn. MINOR PACK-LF oooo. MAJOR LITHOTOMY PACK-LF pppp. MAJOR PACK qqqq. MAJOR PACK-LF rrrr. MINOR GENERAL PACK ssss. MINOR ACUTE PACK-LF tttt. BASIC PACK uuuu. GENERAL PACK-LF vvvv. MAJOR BASIN PACK-LF wwww. VASCULAR SSC PACK xxxx. DAVINCI PACK-LF yyyy. SINGLE BASIN PLUS 1-LF zzzz. CUSTOM LID PACK-LF aaaaa. BARIATRIC PACK-LF bbbbb. SINGLE BASIN PLUS 4-LF ccccc. MINOR OR SET-UP PACK-LF ddddd. MINOR LAP PACK eeeee. TRAUMA PACK-LF fffff. MAJOR LITHOTOMY PACK-LF ggggg. MINOR LITHOTOMY PACK-LF hhhhh. MAJOR PROCEDURE PACK-LF iiiii. MINOR PROCEDURE PACK-LF jjjjj. DEEP BRAIN STIMULATION PACK kkkkk. VOORHEES SUMMIT T AND A PK-LF lllll. BASIC PACK-LF mmmmm. ASCI BASIC PACK nnnnn. GASTRIC BY PASS PACK-LF ooooo. MINOR PACK-LF ppppp. MAJOR SET-LF qqqqq. BASIC PACK-LF rrrrr. TRMC- GENERAL SURGERY PACK sssss. TRMC- PERI GYN PACK ttttt. PEDIATRIC PACK uuuuu. PENILE PROSTHESIS PK W/AUX vvvvv. ACCOLA AVR/MVR COMPONENT PACK wwwww. ACCOLA BASIC PACK xxxxx. BASIC SET UP PACK-LF yyyyy. MAJOR ABDOMINAL PK zzzzz. THOROCOTOMY PACK-LF aaaaaa. MINOR BASIN PACK bbbbbb. MINOR PROCEDURE KIT-LF cccccc. BIRTHDAY KIT-DOUBLE BASIN-LF dddddd. VASCULAR MAJOR BASIN-LF eeeeee. SINGLE BASIN PACK ffffff. MAJOR BASIN PACK-LF gggggg. GENERAL BASIC PACK hhhhhh. BASIC PACK iiiiii. MINOR PACK jjjjjj. CV PACK A-LF kkkkkk. KIDNEY PACK-LF llllll. GENERAL SURGERY PACK-LF mmmmmm. MINOR BASIC PACK-LF nnnnnn. MAJOR LAP PK-LF oooooo. PEDI PK-LF pppppp. THORACOTOMY PK qqqqqq. PLASTIC SOFT TISSUE #51-RF rrrrrr. ADULT LIVER TRANSPLANT PK ssssss. THORACIC-RF-LF tttttt. BASIC SET UP PACK uuuuuu. MINOR BASIC TRAY SC-LF vvvvvv. BASIC MAJOR PACK-LF wwwwww. ACDF PACK xxxxxx. MAJOR PACK yyyyyy. MINOR PACK-LF zzzzzz. VASCULAR PACK-LF aaaaaaa. BASIC PACK-LF bbbbbbb. CUSTOM THORACOTOMY ccccccc. PEDIATRIC BASIC MINOR PACK-LF ddddddd. MINOR HERNIA-LF eeeeeee. MAJOR PACK-LF fffffff. MINOR SET UP PACK-LF ggggggg. CORE PACK hhhhhhh. PEDIATRIC PACK-LF iiiiiii. GENERAL PA
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·February 15, 2023