17 results
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41ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SG Lanset I, SG Lancets, Soft Lancets
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Zavation
FDA UDI
Zavation LLC·00197157002800·CIF 14x18, 7 deg, -12
Plateau-V Spacer System
FDA UDI
Life Spine, Inc.·00190837029074·PLATEAU-V Interbody, Straight, Bulleted, 12mm x...
DELTA XTEND
FDA UDI
DEPUY (IRELAND)·10603295115649·DELTA Xtend MONOBLOC HUM TRIAL EPI 2 DIA 12 LONG
DELTA XTEND
FDA UDI
DEPUY (IRELAND)·10603295115618·DELTA Xtend MONOBLOC HUM TRIAL EPI 1 DIA 12 STD
DELTA XTEND
FDA UDI
DEPUY (IRELAND)·10603295115601·DELTA Xtend MODULAR HUMERAL STEM TRIAL DIA 12 MM
DELTA XTEND
FDA UDI
DEPUY (IRELAND)·10603295115625·DELTA Xtend MONOBLOC HUM TRIAL EPI 1 DIA 12 LONG
DELTA XTEND
FDA UDI
DEPUY (IRELAND)·10603295115632·DELTA Xtend MONOBLOC HUM TRIAL EPI 2 DIA 12 STD
AMSURE URETHRAL CATHETERIZATION TRAY
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Rumble Tuff Electric Breast Pump
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
OPTIFLUX 160NRE DIALYZER FINISHED ASSY
FDA Adverse Event
Malfunction
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FJI·October 22, 2014
V.A.C. THERAPY SYSTEM
FDA Adverse Event
Injury
·KCI USA, INC.·Product code OMP·August 17, 2011
5.5MM TI MATRIX POLYAXIAL SCREW 45MM THREAD LENGTH
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code NKB·July 17, 2013
MEDLINE
FDA Adverse Event
Malfunction
·SHANGHAI KINDLY ENTERPRISEDEVELOPMENTGROUP CO.,LTD·Product code FMI·June 7, 2024
Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.
FDA Enforcement
Class I
·Terminated·Animas Corporation·April 10, 2013
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Part Number/Part Description: 30-0033-S 30mm Acutrak¿ Fusion Device 6mm Nose AM-0025-S 25.0mm Acutrak¿ 4/5 Bone Screw AM-0030-S 30.0mm Acutrak¿ 4/5 Bone Screw AM-0035-S 35.0mm Acutrak¿ 4/5 Bone Screw AM-0040-S 40.0mm Acutrak¿ 4/5 Bone Screw AM-0045-S 45.0mm Acutrak¿ 4/5 Bone Screw AM-0050-S 50.0mm Acutrak¿ 4/5 Bone Screw AP-67100-S 100mm Acutrak¿ 6/7 Fixation Screw AP-67105-S 105mm Acutrak¿ 6/7 Fixation Screw AP-67110-S 110mm Acutrak¿ 6/7 Fixation Screw AP-67115-S 115mm Acutrak¿ 6/7 Fixation Screw AP-67120-S 120mm Acutrak¿ 6/7 Fixation Screw AP-6740-S 40mm Acutrak¿ 6/7 Fixation Screw AP-6745-S 45mm Acutrak¿ 6/7 Fixation Screw AP-6750-S 50mm Acutrak¿ 6/7 Fixation Screw AP-6755-S 55mm Acutrak¿ 6/7 Fixation Screw AP-6760-S 60mm Acutrak¿ 6/7 Fixation Screw AP-6765-S 65mm Acutrak¿ 6/7 Fixation Screw AP-6770-S 70mm Acutrak¿ 6/7 Fixation Screw AP-6775-S 75mm Acutrak¿ 6/7 Fixation Screw AP-6780-S 80mm Acutrak¿ 6/7 Fixation Screw AP-6785-S 85mm Acutrak¿ 6/7 Fixation Screw AP-6790-S 90mm Acutrak¿ 6/7 Fixation Screw AP-6795-S 95mm Acutrak¿ 6/7 Fixation Screw ATF-140-S 14.0mm Acutrak¿ Fusion Device ATF-160-S 16.0mm Acutrak¿ Fusion Device ATF-180-S 18.0mm Acutrak¿ Fusion Device ATF-200-S 20.0mm Acutrak¿ Fusion Device ATF-220-S 22.0mm Acutrak¿ Fusion Device ATF-240-S 24.0mm Acutrak¿ Fusion Device ATF-270-S 27.0mm Acutrak¿ Fusion Device ATF-320-S 32.0mm Acutrak¿ Fusion Device ATF-370-S 37.0mm Acutrak¿ Fusion Device ATM-100-S 10.0mm Mini Acutrak¿ Fixation Screw ATM-120-S 12.0mm Mini Acutrak¿ Fixation Screw ATM-140-S 14.0mm Mini Acutrak¿ Fixation Screw ATM-160-S 16.0mm Mini Acutrak¿ Fixation Screw ATM-180-S 18.0mm Mini Acutrak¿ Fixation Screw ATM-200-S 20.0mm Mini Acutrak¿ Fixation Screw ATM-220-S 22.0mm Mini Acutrak¿ Fixation Screw ATM-240-S 24.0mm Mini Acutrak¿ Fixation Screw ATM-260-S 26.0mm Mini Acutrak¿ Fixation Screw
FDA Enforcement
Class II
·Ongoing·Acumed LLC·January 4, 2023