12 results
·
28ms
·
Sources: EU EUDAMED, US FDA
VASCULAR RECORDER #301
FDA 510(k)
FDA Class 2
·Cardiovascular
Ophthalmic Spatula
FDA UDI
KATENA PRODUCTS, INC.·00841668102688·CHANG COMBINATION CHOPPER, LEFT
MAGELLAN ROBOTIC SYSTEM, MAGELLAN ROBOTIC CATHETER 9FR
FDA 510(k)
FDA Class 2
·Cardiovascular
MODIFICATION TO: APEXPRO TELEMETRY SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
PUMP 381 PUMP SET (US)
FDA Adverse Event
Injury
·ABIOMED, INC. - 1220648·Product code OZD·March 17, 2026
OPTETRAK
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·May 9, 2025
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
DANYANG MAXTHAI MEDICAL EQUIPMENT·Product code ITJ·May 27, 2014
UNKNOWN DEPUY PINNACLE METAL LINER
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code JDI·November 14, 2012
ACCESS® 2 IMMUNOASSAY CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code MMI·September 13, 2010
5.0MM TI LOCKING SCREW W/T25 STARDRIVE 38MM F/IM NAIL-STER
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HWC·May 1, 2019
LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 11MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·March 6, 2024
OPTETRAK, Advanced Patella, 3 Peg Implant, Item Numbers: a) 200-07-26, 26MM; b) 200-07-29, 29MM; c) 200-07-32, 32MM; d) 200-07-35, 35MM; e) 200-07-38, 38MM
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·June 26, 2024