13 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Reprocessed Response Diagnostic Electrophysiology Catheters
FDA 510(k)
FDA Class 2
·Cardiovascular
OSTEOSCAF
FDA 510(k)
FDA Class 2
·Dental
SONIX ULTRASOUND SCANNER
FDA 510(k)
FDA Class 2
·Radiology
Matrixx System
FDA UDI
NEXXT SPINE, LLC·00889929036938·Corpectomy, 16Dx18Wx27H 6°
Matrixx System
FDA UDI
NEXXT SPINE, LLC·00889929065884·Corpectomy, 16Dx18Wx27H 0°
SPRINT QUATTRO SECURE
FDA Adverse Event
Malfunction
·MPRI·Product code LWS·October 10, 2014
PROSIMA PELVIC FLOOR REPAIR KIT
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTP·June 11, 2013
TRIFECTA VALVE
FDA Adverse Event
Injury
·ST JUDE MEDICAL BRASIL LTDA·Product code LWR·July 8, 2011
UNKNOWN KNEE TIBIAL TRAY
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JWH·October 8, 2019
UNKNOWN KNEE TIBIAL INSERT
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JWH·October 8, 2019
UNKNOWN KNEE FEMORAL
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JWH·October 8, 2019
BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code DQO·November 26, 2025
REF 800-05-035, ENZTEC FEMORAL IMPACTOR - DJO, (01) 09421028110624 (10) 999999, To be used only with DJO EMPOWR 3D KNEE
FDA Enforcement
Class II
·Terminated·Enztec Limited·February 3, 2021