10,000 results · 76ms · Sources: EU EUDAMED, US FDA

GENCHEM™ CO2 Acid Reagent

FDA UDI
GENCHEM INC·00851445007167·10/17/2022

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval
FDA Class 3 ·Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D,Compia M

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Aurora EV ICD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT VR ICD, Mirro MRI DR ICD, Mirro MRI VR IC

FlexTEMP System, Sensor - 989803178171

FDA registration
Philips North America LLC·1 product·🇺🇸 United States

FlexTEMP System, Sensor - 989803178171

FDA registration
Philips Electronics Ltd·1 product·🇨🇦 Canada

FlexTEMP System, Sensor - 989803178171

FDA registration
INVIVO CORPORATION·1 product·🇺🇸 United States

FlexTEMP System, Sensor - 989803178171

FDA registration
Philips North America LLC·1 product·🇺🇸 United States

COBAS INTEGRA REAGENT CASSETTES

FDA registration
ROCHE DIAGNOSTICS GMBH·13 products·🇩🇪 Germany

ELECSYS AFP

FDA registration
ROCHE DIAGNOSTICS GMBH·1 product·🇩🇪 Germany

cobas pro system software

FDA registration
ROCHE DIAGNOSTICS GMBH·4 products·🇩🇪 Germany

COULTER GEN-S SYSTEM

FDA 510(k)
FDA Class 2 ·Hematology

Trima Accel System, Wireless Solution & Labeling Update Update (7 day Platelet Bag Claim)

FDA registration
Terumo BCT, Inc..·1 product·🇺🇸 United States

C4 Gen.2, 150Tests, cobas c 701

FDA registration
ROCHE DIAGNOSTICS GMBH·1 product·🇩🇪 Germany

PHENYTOIN CALIBRATORS

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

Stomach Tube

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

PHENYTION EIA TEST

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

Well Lead Ureteral Access Sheath

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

THEOPHYLLINE CALIBRATORS

FDA 510(k)
FDA Class 2 ·Clinical Toxicology