BACTICARD STREP

FDA 510(k)

FDA Class 1 ·Microbiology

VYGON MULTI-DOSE VIAL ADAPTER & BIONECTOR

FDA 510(k)

FDA Class 2 ·General Hospital

POWDER-FREE VINYL EXAM GLOVES

FDA 510(k)

FDA Class 1 ·General Hospital

BACT/ALERT BLOOD COLLECTION ADAPTER CAP AND INSERT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CleverLock Guidewire Locking Device and Biopsy Cap

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CONTROL III ELITE

FDA 510(k)

FDA Class 1 ·General Hospital

SIMUPLAN TREATMENT PLANNING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

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

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AFFIRM PROCESSOR

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS

FDA 510(k)

FDA Class 3 ·Orthopedic

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

AFFIRM VP MICROBIAL ID TEST FOR TRICHOMONAS VAGINA

FDA 510(k)

FDA Class 1 ·Microbiology

GAUZE SPONGE

FDA 510(k)

FDA Unclassified ·Unknown