16 results · 23ms · Sources: EU EUDAMED, US FDA

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FREEDOM ND: YAG LASER SYSTEM

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

SCREW SYSTEM

FDA UDI
Biomet Orthopedics, LLC·00880304213920·

ALEUTIAN SPACER SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

AUTOSET SPIRIT CPAP SYSTEM

FDA 510(k)
FDA Class 2 ·Anesthesiology

MAESTRO TOTAL WRIST CAPITATE STEM 6X12MM

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWJ·August 7, 2018

MAESTRO TOTAL WRIST CARPAL HEAD 7X15MM STD

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWJ·August 7, 2018

MAESTRO TOTAL WRIST RADIAL STEM 6.0X40MM

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWJ·August 7, 2018

ADVIA CENTAUR XP HCV ASSAY

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MZO·December 19, 2012

MAESTRO TOTAL WRIST DISTAL RADIAL BODY

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWJ·August 7, 2018

MAESTRO TOTAL WRIST CARPAL PLATE 9X37 AUG 6

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWJ·August 7, 2018

HOMECHOICE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·May 15, 2013

UNKNOWN DEPUY SCREWS

FDA Adverse Event
Malfunction ·DEPUY ORTHOPAEDICS, INC.·Product code HWC·May 17, 2011

L-70 HOTLINE 2 FLUID WARMING SET WITHOUT INJECTION PORT

FDA Adverse Event
Malfunction ·SMITHS MEDICAL ASD, INC.·Product code FPA·May 23, 2008

R3 XLPE INSERT

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC.·Product code JDI·May 25, 2025

EMBLEM S-ICD Model A209

FDA Enforcement
Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

Model Number L231, PROPONENT DR EL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025