5,040 results · 22ms · Sources: EU EUDAMED, US FDA

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Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval
FDA Class 2 ·GE SENOGRAPHE ESSENTIAL FULL FIELD MAMMOGRAPHY SYSYTEM (SENO ESSENTIAL

Accessories, Soft Lens Products

FDA Pre-Market Approval
FDA Class 2 ·PD 1343 DISINFECTING TABLET

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator

Accessories, Soft Lens Products

FDA Pre-Market Approval
FDA Class 2 ·EASY EYES (TM)

Accessories, Soft Lens Products

FDA Pre-Market Approval
FDA Class 2 ·BLAIREX STERILE SALINE SOLUTION

Suture, Nonabsorbable, Synthetic, Polyamide

FDA Pre-Market Approval
FDA Class 2 ·SUPRAMID EXTRA SUTURES

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval
FDA Class 2 ·SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval
FDA Class 2 ·LEOCOR PICOCATH(TM) MODEL PICO-ST

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval
FDA Class 2 ·MEDI-TECH CORONARY BALLOON DILATATION CATHETER SYS

Accessories, Soft Lens Products

FDA Pre-Market Approval
FDA Class 2 ·B&L THERMA-ZYME, FIZZICLEAN

Radioimmunoassay For Cyclosporine

FDA Pre-Market Approval
FDA Class 2 ·1YCLO-TRAC SP WHOLE BLOOD & SERUM/PLASMA ASSAYS

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval
FDA Class 2 ·FINISHED METHAFILCON A CONTACT LENSES

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON E170 IMMUNOASSAY ANALYZER

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval
FDA Class 2 ·OCU-FLEX

Accessories, Soft Lens Products

FDA Pre-Market Approval
FDA Class 2 ·PREFLEX AND FLEXCARE SOL.

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval
FDA Class 2 ·SLEEK PTCA DILATATION CATHETERS W/3 & 4CM BALLONS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval
FDA Class 2 ·MICROSOFTRAC (R) PTCA CATHETER

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval
FDA Class 2 ·SPHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES

Accessories, Soft Lens Products

FDA Pre-Market Approval
FDA Class 2 ·THIMEROSAL PRESERVED SALINE SOLUTION

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval
FDA Class 2 ·RAY TFC DEVICE AND RAY TFC UNITE DEVICE