19 results
·
24ms
·
Sources: EU EUDAMED, US FDA
BIO-TEK EL 401 HANDHELD MICROPLATE WASHER
FDA 510(k)
FDA Class 1
·Microbiology
Audit MicroControls Method Val FD GFAP for bioMérieux VIDAS® TBI (GFAP)
FDA UDI
AALTO SCIENTIFIC·B085K853M200·
CO2 Laser Treatment Machine (CFR3M1)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
COEURLOCK STERILE DISPOS. ANGIOGRAPHIC
FDA 510(k)
FDA Class 2
·Cardiovascular
MONOPOLAR CURVED SCISSORS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·June 6, 2014
VITALITY 2
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 5, 2010
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD·Product code MCM·December 3, 2012
VNGD SSK PSC TIB BRG 12X63/67
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·December 5, 2023
VNGD POST FEM AUG 65X10 LL/RM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·December 5, 2023
BIOMET CC CRUCIATE TRAY 71MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·August 16, 2016
BIOMET TIB BLOCK 6MM 67
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·December 5, 2023
BMET ARCOM AP PAT 3PST 34MM MD
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·December 5, 2023
VNGD POST FEM AUG 65X5 RL/LM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·December 5, 2023
BIOMET ILOK STEM TIB TRAY 67MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·December 5, 2023
BMT SPLINED KNEE STM 24X80
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·December 5, 2023
BIOMET TIB BLOCK 6MM 67
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·December 5, 2023
VNGD SSK INTLK FMRL 65 LT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·December 5, 2023
BMT SPLINED KNEE STM 18X80
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·December 5, 2023
Sternal Valve Retractors With Atrial and Aortic Rakes; Models SRCL-1, SRCL-AR, SRLP-1, SRLP-AR, ATR-1, ATR-AR, CSR-1 and CSR-AR. For use in cardiac surgery.
FDA Enforcement
Class II
·Ongoing·Genesee BioMedical, Inc.·June 6, 2018