14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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