13 results
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20ms
·
Sources: EU EUDAMED, US FDA
Laon Ortho
FDA 510(k)
FDA Class 2
·Dental
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780184607·Integra® Jarit® Hibbs Gouge, 9-1/2", Curved, 1-...
devemed
FDA UDI
devemed GmbH·04061644032327·Bone chisel "Kramer-Nevins" | 5 mm
straight
F-L...
CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel
FDA 510(k)
FDA Class 3
·Cardiovascular
WIRION
FDA 510(k)
FDA Class 2
·Cardiovascular
Reicodent
FDA UDI
devemed GmbH·04061644036912·Bone chisel "Kramer-Nevins" | 5 mm
straight
COM...
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 8, 2025
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 22, 2017
OT VERIO IQ METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 1, 2017
ASR ACETABULAR CUPS 56
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·September 15, 2011
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·November 14, 2014
FRESENIUS DIALYSIS DELIVERY SYSTEM
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·July 23, 2013
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013