Innovo

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFICATION: TO DEPUY DELTA CERAMIC FEMORAL HEAD

FDA 510(k)

FDA Class 2 ·Orthopedic

ACCU-SPACE ABSORBABLE SEEDING SPACERS

FDA 510(k)

FDA Class 2 ·Radiology

ACTI-FLEX IV ADMINISTRATION SET

FDA 510(k)

FDA Class 2 ·General Hospital

PLATELIN L

FDA 510(k)

FDA Class 2 ·Hematology

VITROS IMMUNODIAGNOSTICS PRODUCTS/TSH REAGENT PACK (GEM. 1001)/TSH CALIBRATORS(GEM.C001)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MODIFICATION HEMOFILTRATION CATHETER HF-100

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

OT IGG SORBENT

FDA 510(k)

FDA Class 2 ·Immunology

VYGON MULTI-DOSE VIAL ADAPTER & BIONECTOR

FDA 510(k)

FDA Class 2 ·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

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

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