8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
OMNI-TRACT CORRAL RETRACTOR
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
EV-804 OTC Pain Relief TENS
FDA 510(k)
FDA Class 2
·Neurology
VENDYS, MODEL 6000 B B/C
FDA 510(k)
FDA Class 2
·Cardiovascular
FORTIFY ASSURA VR, DF-4 CONNECTOR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·June 13, 2014
DUR MAR NEUT LINER 28IDX58OD
FDA Adverse Event
Injury
·DEPUY INT'L, LTD.·Product code LPH·October 14, 2010
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·December 13, 2012
General Pack, part number AMS2967(A General Pack, part number AMS3239(A General Pack, part number AMS3709(B General Pack, part number AMS5341 General Pack, part number AMS5694
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026