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

O.R./SURGEONS GOWN, ITEM NO. 4962

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ENDOSCOPIC SCISSORS (DISPOSABLE/REUSABLE SHAFTS)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AN1087 Dosimeter

FDA 510(k)

FDA Class 2 ·General Hospital

HELIODENT DS

FDA 510(k)

FDA Class 2 ·Dental

TRANS1 AXIAL FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ORTHOFIX TITANIUM NAILING SYSTEMS

FDA 510(k)

FDA Class 2 ·Orthopedic

Weck Hem-o-lok Auto Endo5 Ligating Clip Applier

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Web II Memory Extraction Basket or Memory II Double Lumen Extraction Basket, Memory 5 Fr. Soft Wire Baskets or Memory Helical Stone Extractor, Memory Eight Wire Baskets or Memory Hard Wire Baskets, Fusion Wire Guided Extraction Basket, Non-Lithotripsy Extraction Basket

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology