10,000 results · 53ms · Sources: EU EUDAMED, US FDA

Analyzer, Medical Image

FDA Pre-Market Approval
FDA Class 2 ·QVCAD System (Version 3.3)

Bone Cement

FDA Pre-Market Approval
FDA Class 2 ·PALACOS E-FLOW (OSTEOPAL) BONE CEMENT

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·ORAQUICK HCV RAPID ANTIBODY TEST

Analyzer, Medical Image

FDA Pre-Market Approval
FDA Class 2 ·SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval
FDA Class 2 ·SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval
FDA Class 2 ·KODAK DIRECTVIEW CR MAMMOGRAPHY FEATURE

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval
FDA Class 2 ·SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval
FDA Class 2 ·MODULARIS LITHO

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval
FDA Class 2 ·MENICON SF-P (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·ELECSYS ANTI-HCV ON MODULAR ANALYTICS E170

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval
FDA Class 2 ·DORNIER LITHOTRIPTER TRANSPORTABLE (DLT)

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

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

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

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

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval
FDA Class 2 ·CHARGER PTCA DILATATION CATHETERS

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·ELECSYS ANTI-HCV II

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·ORAQUICK HCV RAPID ANTIBODY TEST

Single-Use Internal Condom

FDA Pre-Market Approval
FDA Class 2 ·REALITY FEMALE CONDOM

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

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

Accessories, Soft Lens Products

FDA Pre-Market Approval
FDA Class 2 ·ULTRAZYME(R) ENZYMATIC CLEANER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval
FDA Class 2 ·FLEXTOME CORONARY CUTTING BALLOON