22 results
·
20ms
·
Sources: EU EUDAMED, US FDA
BILITEC 2000, POLYGRAM '98 PH TESTING APPLICATION (INCL.BILE), OPTICAL FIBER PROBER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040009925·Zirlux 16+ D3 100X12
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033297285·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033297278·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033297261·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033297292·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033297308·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033297315·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00887661581266·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033297254·
THE IMPLEX HEDROCEL ACETABULAR AUGMENT, XX-YYY-ZZZZ
FDA 510(k)
FDA Class 2
·Orthopedic
AFOCUS ELECTROPYSIOLOGY CATHETER SYSTEM, MODELS 81550, 81567, 81568, 81569
FDA 510(k)
FDA Class 2
·Cardiovascular
OT ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·January 27, 2011
UNKNOWN PERSONA KNEE BEARING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·March 6, 2018
UNKNOWN PERSONA KNEE FEMORAL
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·March 6, 2018
ACCU-CHEK ® MOBILE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·March 19, 2013
COLLEAGUE CXE VOLUMETRICINFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·March 9, 2011
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Injury
·ROCHE DIAGNOSTICS·Product code LFR·March 11, 2008
UNKNOWN PERSONA KNEE TIBIAL TRAY
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·March 6, 2018
Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025