14 results · 21ms · Sources: EU EUDAMED, US FDA

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MRCP+ version 2 (MRCP+ v2)

FDA 510(k)
FDA Class 2 ·Radiology

KAPP CUSTOM ULNAR HEAD WRIST IMPLANT

FDA 510(k)
FDA Class 2 ·Orthopedic

FLOWER REAR FOOT PLATING SET, FLOWER CALCANEUS PLANTING SET, FLOWER REARFOOT PLATING SET

FDA 510(k)
FDA Class 2 ·Orthopedic

WALLFLEX ESOPHAGEAL

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code ESW·January 16, 2025

WALLFLEX ESOPHAGEAL

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code ESW·January 23, 2025

ALINITY I TOXO IGM REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT GMBH·Product code LGD·April 22, 2026

WALLFLEX ESOPHAGEAL

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code ESW·February 14, 2025

PUMP MMT-722NAS PRDGM INS V2.2 SK EN

FDA Adverse Event
Injury ·MEDTRONIC MINIMED·Product code LZG·November 14, 2008

DEPUY ASR XL FEM IMP SIZE 46

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL·Product code KWA·September 6, 2011

DERMABOND ADVANCED TOPICAL SKIN ADHESIVE

FDA Adverse Event
Malfunction ·ETHICON INC.·Product code MPN·July 18, 2013

ALINITY I TOXO IGM REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT GMBH·Product code LGD·June 2, 2025

WALLFLEX ESOPHAGEAL

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code ESW·May 28, 2025

ALINITY I TOXO IGM REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT GMBH·Product code LGD·September 11, 2025

HA Pins (DFS HA Cort Screw), Hoffman/Colles Pins (Colles CSER Sterile w/ Pin Kit) Item Nos: HAA60-09030 HAA60-09040 HAA60-10030 HAA60-10040 HAA60-11030 HAA60-11040 HAA60-11050 HAA60-12040 HAA60-12060 HAA60-13030 HAA60-13040 HAA60-13050 HAA60-13060 HAA60-13070 HAA60-14050 HAA60-14080 HAA60-14090 HAA60-15020 HAA60-15030 HAA60-15040 HAA60-15050 HAA60-15060 HAA60-16030 HAA60-16040 HAA60-16050 HAA60-16070 HAA60-16090 HAA60-17040 HAA60-17060 HAA60-17080 HAA60-18010 HAA60-18030 HAA60-18040 HAA60-18050 HAA60-18060 HAA60-18090 HAA60-20030 HAA60-20040 HAA60-20050 HAA60-20060 HAA60-20080 HAA60-20090 HAA60-22050 HAA60-22060 HAA60-25030 HAA60-25040 HAA60-25050 HAA60-25060 HAA60-30060 HAB60-09030 HAB60-10030 HAB60-10040 HAB60-11040 HAB60-11050 HAB60-12040 HAB60-12060 HAB60-13040 HAB60-13050 HAB60-13060 HAB60-14050 HAB60-15060 HAB60-16070 HAB60-16090 HAB60-17080 HAB60-18010 HAB60-18090 HAB60-20080 HAB60-20090 808200000 Product Usage: These devices are intended for osteosynthesis, external fixation of fractures or bone lengthening procedures.

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019