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