11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STATIM 2000 G4 CASSETTE
FDA 510(k)
FDA Class 2
·General Hospital
RESORBABLE SCREW ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
OSBONE DENTAL
FDA 510(k)
FDA Class 2
·Dental
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 9, 2025
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 14, 2013
6.5MM X 45MM S-LOK CANN PLY SCREW
FDA Adverse Event
Injury
·PRECISION SPINE, INC.·Product code MNH·September 17, 2014
PINNACLE MTL INS NEUT36IDX52OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·May 18, 2011
CARDIOSAVE HYBRID
FDA Adverse Event
Injury
·DATASCOPE CORP. - MAHWAH·Product code DSP·June 11, 2020
CARDIOSAVE Intra-Aortic Balloon Pump An electromechanical system used to inflate and deflate intra-aortic balloons. It provide temporary support to the left ventricle via the principle of counterpulsation.
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·January 16, 2013
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
Model Number L231, PROPONENT DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025