22 results
·
20ms
·
Sources: EU EUDAMED, US FDA
SDI SB OFFICE, MODEL 29-
FDA 510(k)
FDA Class 2
·Anesthesiology
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040009918·Zirlux 16+ D2 100X12
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033211922·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033297223·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033297216·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033297193·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033297230·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033297179·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033297186·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033297247·
R & D 4K RETIC
FDA 510(k)
FDA Class 2
·Hematology
E-Z LINK CROSS CONNECTOR
FDA 510(k)
FDA Class 2
·Orthopedic
M2A-MAGNUM MOD HEAD
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·March 20, 2020
M2A-MAGNUM RECAP CUP
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·March 20, 2020
M2A-MAGNUM 42-50 TAPER INSRT STD
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·March 20, 2020
OT ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·January 27, 2011
ACCU-CHEK ® MOBILE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·March 19, 2013
ASR ACETABULAR CUPS 52
FDA Adverse Event
Injury
·DEPUY INTL., LTD.·Product code KWA·March 4, 2011
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Injury
·ROCHE DIAGNOSTICS·Product code LFR·March 11, 2008
XP-XP Tibial Tray - Interlok 71 mm Item # 195755
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 18, 2019