8 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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High Pressure Tubing
FDA 510(k)
FDA Class 2
·Cardiovascular
Ophthalmic Spatula
FDA UDI
KATENA PRODUCTS, INC.·00841668102817·NEUHANN NUCLEUS DIVIDER
BONE CEMENT RADIO-OPACIFIER
FDA 510(k)
FDA Class 2
·Neurology
Apolo D / Apolo S
FDA 510(k)
FDA Class 2
·Radiology
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·October 23, 2014
PFC KEEL TIB TRAY CEM SZ3
FDA Adverse Event
Injury
·DEPUY RAYNHAM·Product code JWH·September 2, 2011
KENTROX RV-S 65 STEROID
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code NVY·July 18, 2013
Zenith Alpha Abdominal Endovascular Graft, Reference Part Numbers: ZIMB-22-108, ZIMB-22-118, ZIMB-22-128, ZIMB-22-70, ZIMB-22-84, ZIMB-22-98, ZIMB-24-108, ZIMB-24-118, ZIMB-24-128, ZIMB-24-70, ZIMB-24-84, ZIMB-24-98, ZIMB-26-108, ZIMB-26-118, ZIMB-26-128, ZIMB-26-70, ZIMB-26-84, ZIMB-26-98, ZIMB-28-108, ZIMB-28-118, ZIMB-28-128, ZIMB-28-70, ZIMB-28-84, ZIMB-28-98, ZIMB-30-108, ZIMB-30-118, ZIMB-30-128, ZIMB-30-70, ZIMB-30-84, ZIMB-30-98, ZIMB-32-108, ZIMB-32-118, ZIMB-32-128, ZIMB-32-70, ZIMB-32-84, ZIMB-32-98, ZIMB-36-108, ZIMB-36-118, ZIMB-36-128, ZIMB-36-70, ZIMB-36-84, ZIMB-36-98
FDA Enforcement
Class II
·Terminated·Cook Inc.·June 26, 2019