12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LIFE-CARE VAGINAL PROBE LIFE-CARE ANAL PROBE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TRAXX ELECTRIC WHEELCHAIR
FDA 510(k)
FDA Class 2
·Physical Medicine
SOLCART B
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MONOSYN VIOLET 5/0 (1) 70CM HR17 (M).RCP
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAM·October 19, 2023
UKNOWN NEXGEN KNEE
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JWH·May 17, 2013
S4S/SUR-FIT NATURA 2PC-2PC DURAHESIVE (DH)
FDA Adverse Event
Injury
·CONVATEC INC.·Product code EXE·September 17, 2014
VIRTUOSO DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWS·June 13, 2011
MARYLAND BIPOLAR FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·December 16, 2013
Microtek Franz Angiography Drape with Radiation Shield, Item # RBA202, and Microtek Angiography Drape with Radiation Shield and Pouches, Item # RBA203. Sterile EO. Microtek Medical, Inc., Columbus, MS 39702.
FDA Enforcement
Class II
·Terminated·Ecolab Inc·September 14, 2016
BIOINTRAFIX SHEATH, SMALL
FDA Adverse Event
Injury
·DEPUY MITEK·Product code MBI·March 4, 2008
BIOINTRAFIX SCREW, 6-7 X 30MM
FDA Adverse Event
Injury
·DEPUY MITEK·Product code HWC·March 4, 2008
SOMATOM Edge Plus-Computed tomography system Model 1026700
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·January 19, 2022