VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL B-HCG REAGENT PACK (GEM.1075), TOTAL B-HCG CALIBRATORS (GEM.C075)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ULTRACISION HARMONIC SCALPEL SYSTEM, MODELS GEN01, GEN02, GEN03, HP052, HP053, HSA07

FDA 510(k)

FDA Unclassified ·Unknown

NUTRISAFE ENTERAL FEEDING TUBE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

COMET ANTERIOR CERVICAL PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

NELLCOR PURITAN BENNETT, 840 VENTILATOR SYSTEM (MODEL 840)

FDA 510(k)

FDA Class 2 ·Anesthesiology

SERVO VENTILATOR 300A

FDA 510(k)

FDA Class 2 ·Anesthesiology

MEDISISS PHACOEMULSIFICATION TIPS/NEEDLES

FDA 510(k)

FDA Class 2 ·Ophthalmic

CDI(TM) H/S CUVETTE, MODIFICATION

FDA 510(k)

FDA Class 2 ·Cardiovascular

SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B

FDA 510(k)

FDA Class 1 ·Microbiology

BIO* NEPHROSS ANDANTE, MODERATO, ALLEGIO H.F.

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

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

BACT/ALERT FAN CULTURE BOTTLE

FDA 510(k)

FDA Class 1 ·Microbiology

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