VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3 UPTAKE CALIBRATORS (GEM.C025)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class)

FDA 510(k)

FDA Class 2 ·Radiology

MODIFICATION TO: ARTHREX V-TAK

FDA 510(k)

FDA Class 2 ·Orthopedic

MENIX®; MENIX® DUO

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set

FDA 510(k)

FDA Class 2 ·Cardiovascular

PeriView FLEX

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

PULLUP BTB Adjustable Fixation System for Ligament Reconstruction, PULLUP CLIP Adjustable Fixation System for Ligament Reconstruction, PULLUP TEX CLIP Adjustable Fixation System for Ligament Reconstruction, BT LOOP Adjustable Fixation System for Ligament Reconstruction

FDA 510(k)

FDA Class 2 ·Orthopedic

COAG-A-MATE - RA4

FDA 510(k)

FDA Class 2 ·Hematology

FERTILMARQ TEST KIT

FDA 510(k)

FDA Class 2 ·Hematology

SISS REPROCESSED HOT BIOPSY FORCEPS, LAPAROSCOPIC, ENDOSCOPIC AND ELECTROSURGICAL SURGICAL INSTRUMENTS AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MUSTANG BALLOON DILATATION CATHETERS

FDA 510(k)

FDA Class 2 ·Cardiovascular

O'REGAN DISPOSABLE ANOSCOPE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

P.F.C. CERAMIC HIP HEAD

FDA 510(k)

FDA Class 2 ·Orthopedic

NEXT GENERATION KNEE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

USCI(R) ACCESS(TM) INTRODUCER SET

FDA 510(k)

FDA Class 2 ·Cardiovascular

GEMINI GXL

FDA 510(k)

FDA Class 2 ·Radiology

COSMED K4

FDA 510(k)

FDA Class 2 ·Anesthesiology

T4 NO SPIN(TM) COATED TUBE RADIOIMMUNOASSAY KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE

FDA 510(k)

FDA Class 2 ·Cardiovascular

Millipede 088 Access Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular