17 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Quadra P
FDA 510(k)
FDA Class 2
·Orthopedic
QUADRA-P FEMORAL STEMS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·November 18, 2025
VERSAFITCUP DM DOUBLE MOBILITY HC LINER 50/28
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·May 17, 2021
CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 60
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·July 10, 2024
LINER: MPACT DM DOUBLE MOBILITY HC LINER 28/DMH
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·January 13, 2023
MPACT ACETABULAR SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·February 6, 2025
MECTACER BIOLOX DELTA FEMORAL BALL HEAD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·July 16, 2025
Fisherbrand
FDA UDI
FISHER SCIENTIFIC COMPANY L.L.C.·00613647000038·PUCH SS AUTOCL 5-1/4X10 200/PK
NEWFIX SCREW, WIRE AND PIN FIXARION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
RELIEVA SOLO ELITE SINUS BALLOON CATHETER
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
PFC*SIGMA/RD/DOME PAT 3PEG,32
FDA Adverse Event
Injury
·9616671 DEPUY (IRELAND)·Product code JWH·June 21, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 27, 2011
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL MANUFACTURING CORPORATION·Product code MVK·August 4, 2014
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
FLEXCATH ADVANCE STEERABLE SHEATH
FDA Adverse Event
Injury
·MEDTRONIC CRYOCATH LP·Product code DRA·November 9, 2018
ACHIEVE MAPPING CATHETER
FDA Adverse Event
Injury
·MEDTRONIC CRYOCATH LP·Product code DRF·November 9, 2018
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025