14 results · 22ms · Sources: EU EUDAMED, US FDA

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GMK Hinge, GMK Revision

FDA 510(k)
FDA Class 2 ·Orthopedic

GMK-HINGE FEMORAL COMPONENT SIZE 3 R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code KRO·July 25, 2022

GRANDTEC

FDA 510(k)
FDA Class 2 ·Dental

RAPID INTRAVASCULAR CATHETER START SYSTEM 22 GAUGE / 20 GAUGE / 18 GAUGE

FDA 510(k)
FDA Class 2 ·General Hospital

ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION

FDA Adverse Event
Injury ·XERIDIEM MEDICAL DEVICES·Product code PIF·April 18, 2018

URETEX SUP URETHRAL SUPPORT SYSTEM

FDA Adverse Event
Injury ·SOFRADIM PRODUCTION·Product code OTN·April 18, 2013

HERCULES 3 STAGE BALLOON ESOPHAGEAL

FDA Adverse Event
Malfunction ·WILSON-COOK MEDICAL INC·Product code KNQ·May 27, 2011

PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Malfunction ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·September 19, 2008

ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION

FDA Adverse Event
Malfunction ·XERIDIEM MEDICAL DEVICES·Product code PIF·April 25, 2018

FILLER, CALCIUM, SULFATE, PREFORMED PELLETS

FDA Adverse Event
Injury ·SYNTHES (USA)·Product code MQV·April 14, 2015

ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION

FDA Adverse Event
Malfunction ·XERIDIEM MEDICAL DEVICES·Product code PIF·April 25, 2018

ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION

FDA Adverse Event
Death ·XERIDIEM MEDICAL DEVICES·Product code PIF·April 25, 2018

ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION

FDA Adverse Event
Malfunction ·XERIDIEM MEDICAL DEVICES·Product code PIF·April 26, 2018

cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

FDA Enforcement
Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014