10,000 results · 55ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·BIO-RAD MONOLISA ANTI-HBC IGM EIA

Alere Cholestech LDX®

FDA UDI
ALERE SAN DIEGO, INC.·00899722002337·Alere Cholestech LDX® Lipid Profile

Alere Cholestech LDX®

FDA UDI
ALERE SAN DIEGO, INC.·00893038002630·Alere Cholestech LDX® Lipid Profile

Piccolo Lipid Panel

FDA UDI
ABAXIS, INC.·EABA40000251·The Piccolo® Lipid Panel reagent disc, used wit...

Cholestech LDX™

FDA UDI
ALERE SAN DIEGO, INC.·00893038002913·Cholestech LDX™ Lipid Profile

Alere Cholestech LDX®

FDA UDI
ALERE SAN DIEGO, INC.·00893038002647·Alere Cholestech LDX® TC HDL GLU

Cholestech LDX™

FDA UDI
ALERE SAN DIEGO, INC.·00893038002920·Alere Cholestech LDX™ TC HDL GLU

43-5399-058-14, Cemented Tibia Drill Bit 15.7mm Dia. X 58mm

FDA registration
ORCHID UNIQUE·1 product·🇺🇸 United States

WEHRS DOUBLE NOTCH INCUS-STAPES 1MM DIA X 9MM L HA/OTOSIL

FDA registration
MIDWEST STERILIZATION CORP.·2 products·🇺🇸 United States

Cholesterol LDL SL 2G, 4 x 28 mL, REF LDLL-0230-NA

FDA registration
VitalScientific·4 products·🇫🇷 France

Secondary reagents blot (IgM)

FDA UDI
EUROIMMUN Medizinische Labordiagnostika AG·04049016114659·

Sprinter XL (model 160 samples, IFA/ELISA)

FDA UDI
EUROIMMUN Medizinische Labordiagnostika AG·04049016109716·

H. pylori Component Pack

FDA UDI
Gold Standard Diagnostics Corporation·B350GSD011002HCP0·H. pylori Component Pack

Free Protein S Reagent

FDA UDI
HELENA LABORATORIES CORPORATION·M52553630·

Protein S ELISA Kit

FDA UDI
HELENA LABORATORIES CORPORATION·M52552920·

IgG Component Pack - Bulk

FDA UDI
Gold Standard Diagnostics Corporation·B350GSD051700CP0·IgG Component Pack - Bulk

Protein S Antigen Rocket Kit

FDA UDI
HELENA LABORATORIES CORPORATION·M52553590·

Asserachrom® Free Protein S

FDA UDI
DIAGNOSTICA STAGO·03607450009460·

Fungal Serology

FDA UDI
MICROBIOLOGICS INC.·10634853000176·Clarifying Reagent (Sodium Citrate), 20mL

Asserachrom® Total Protein S

FDA UDI
DIAGNOSTICA STAGO·03607450009453·