835 results · 24ms · Sources: EU EUDAMED, US FDA

Analyzer, Medical Image

FDA Pre-Market Approval
FDA Class 2 ·M-VU ALGORITHM ENGINE

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval
FDA Class 2 ·NAVISTAR AND CELSIUS DEFLECTABLE TIP DIAGNOSTIC/ABLATION CATHETERS

Glucose Oxidase, Glucose

FDA Pre-Market Approval
FDA Class 2 ·GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·ARCHITECT ANTI-HCV

Bone Cement

FDA Pre-Market Approval
FDA Class 2 ·SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENT

Accessories, Solution, Ultrasonic Cleaners For Lenses

FDA Pre-Market Approval
FDA Class 2 ·UNIZYME(TM) ENZYMATIC CLEANER

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·LIAISON XL MUREX HCV Ab

Laser, Ophthalmic

FDA Pre-Market Approval
FDA Class 2 ·HYPERION LTK SYSTEM

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT REALTIME HCV GENOTYPE II

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·COBAS AMPLICOR HEPATITIS C VIRUS (HCV) TEST, V2.0

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval
FDA Class 2 ·ECONOLITH(TM) LITHOTRIPTER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval
FDA Class 2 ·SCIMED SINGLE OPERATOR EXCHANGE PTCA CATHETERS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval
FDA Class 2 ·PTCA CATHETERS

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval
FDA Class 2 ·IMMULITE 2500 PSA, IMMULITE 2500 THIRD GENERATION PSA

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval
FDA Class 2 ·CHAMPION WRAP PTCA CATHETER

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval
FDA Class 2 ·GE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval
FDA Class 2 ·PTCA CATHETERS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval
FDA Class 2 ·SPRINTER MX2 BALLOON DILATATION CATHETER

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval
FDA Class 2 ·MOBILE SENOGRAPHE 2000D

Analyzer, Medical Image

FDA Pre-Market Approval
FDA Class 2 ·IMAGECHECKER D, DM, AND OEM-D (SOFTWARE VERSION 5.1)