ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP

FDA 510(k)

FDA Class 2 ·Hematology

M6-C™ Single Use, Disposable Instrumentation

FDA 510(k)

FDA Class 2 ·Orthopedic

M6-C Artificial Cervical Disc Instruments AS

FDA 510(k)

FDA Class 2 ·Orthopedic

BD VACUTAINER PLUS SST SERUM SEPARATOR TUBE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK

LASER SYSTEM YELLOWSTAR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AGILIS NXT STEERABLE INTRODUCER, MODEL G408324

FDA 510(k)

FDA Class 2 ·Cardiovascular

Impulse Angiographic Catheter, Expo Angiographic Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

EN CIRCLR AL ADJUSTABLE LOOP MAPPING CATHETER MODELS, 1045AL1, 1045AL2, 1060AL1, 1060AL2

FDA 510(k)

FDA Class 2 ·Cardiovascular

Specimen Bag, model: WEP040306B, WEP010304B, WEP040304B, WEP010759B, WEP010709B, WEP010304A, WEP010759A, WEP010709A

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AGILIS NXT STEERABLE INTRODUCER, MODEL G408322 AND G408323

FDA 510(k)

FDA Class 2 ·Cardiovascular

84E SERIES SINGLE PLY WRAPPER

FDA 510(k)

FDA Class 2 ·General Hospital

LAC-MAC LIMITED INNERBLOC VARIOUS O.R. DRAPE BASED ON THE REPEL, PLUS AND GORE SURGICAL BARRIER FABRIC MATERIALS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MDC SAFE STEP SAFETY I.V. CATHETER SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

INNERBLOC LR SURGICAL GOWNS BASED ON GORE LR FABRIC (REUSABLE 100X)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LAC-MAC INNERBLOC LR SURGICAL GOWNS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NASAL GASTRIC TUBE RETAINER

FDA 510(k)

FDA Class 2 ·General Hospital

MDC SAFE STEP SAFETY BLOOD COLLECTION NEEDLE SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

SAFESTEP SAFETY DENTAL CARTRIDGE INJECTOR, MODEL 33-00000-1

FDA 510(k)

FDA Class 2 ·Dental

LAC-MAC INNERBLOC O.R. GOWN

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery