17 results · 22ms · Sources: EU EUDAMED, 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