WELLCOLEX COLOUR SHIGELLA TEST ZC51

FDA 510(k)

FDA Class 2 ·Microbiology

EOGas 4 Endo-SteriTest RRBI

FDA 510(k)

FDA Class 2 ·General Hospital

SURGICAL DRAPE PACK

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TRANS1 INTERBODY FUSION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

NOVA GAUZE(R) DISPOSABLE NONWOVEN SPONGES, STERILE

FDA 510(k)

FDA Class 2 ·Neurology

Senhance Surgical System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LINA LOOP, MODELS: EL-160-4, EL-160-8, EL-200-4, EL-200-8

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

DRAPES(SURGICAL, GENERAL & PLASTIC SURGERY)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TrackX

FDA 510(k)

FDA Class 2 ·Radiology

TEEClean(R) Automated TEE Probe Cleaner Disinfector with TEEZyme(R) Cleaner and TD-5(R) or TD-8(R) High Level Disinfectants

FDA 510(k)

FDA Class 2 ·Radiology

TAS HMT CONTROLS

FDA 510(k)

FDA Class 2 ·Hematology

MODIFICATION TO WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM (ALSO REFERRED TO AS) THE WATCHCHILD SYSTEM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

JOBST ATHROMBIC PUMP SYSTEM 2600

FDA 510(k)

FDA Class 2 ·Cardiovascular

TURN EZ BED DEVICE

FDA 510(k)

FDA Class 2 ·Physical Medicine

WILSON-COOK ESOPHAGEAL BALLOON PROSTHESIS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Hem-o-lok® Ligating Clips

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CRP-LEX SYSTEM: C-REACTIVE PROTEIN ANTIGEN DETECTION IN SERUM: SLIDE AGGLUTNATION LATEX TEST

FDA 510(k)

FDA Class 2 ·Immunology

TAS ANALYZER

FDA 510(k)

FDA Class 2 ·Hematology

Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Sheath (Diagnostic)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

THERACLEAR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery