DIESSE CRP TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

Integrity Implants Navigated Instruments

FDA 510(k)

FDA Class 2 ·Neurology

BIOSCREW ABSORBABLE INTERFERENCE SREW

FDA 510(k)

FDA Class 2 ·Orthopedic

ARJOWRAP 47/100 AND 47/88

FDA 510(k)

FDA Class 2 ·General Hospital

074 Zenith Flex System

FDA 510(k)

FDA Class 2 ·Cardiovascular

TRI-LUMEN INTRA VASCULAR BALLOON CATHETER (GU USE)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VITALCARE URETHRAL CATHETER RED RUBBER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

3 CHANNEL DIGITAL AMBULATORY ECG RECORDER MODEL GALIX GBI-3SM

FDA 510(k)

FDA Class 2 ·Cardiovascular

ARTHREX FIBERWIRE IN USP SIZES

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SOPRANO ICE MULTI-APPLICATION & MULTI-TECHNOLOGY PLATFORM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder Compression Screws, Exactech Equinoxe Reverse Shoulder Glenosphere Locking Screw

FDA 510(k)

FDA Class 2 ·Orthopedic

HP-3, BATTETRY OPERATED, FONT WHEEL DRIVE, POWER WHEELCHAIR

FDA 510(k)

FDA Class 2 ·Physical Medicine

DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUID

FDA 510(k)

FDA Class 2 ·Hematology

Vyvo

FDA 510(k)

FDA Class 2 ·Cardiovascular

OPTETRAK LOGIC PS 17MM & 19MM THICK INSERTS, OPTETRAK LOGIC PSC 17MM & 19MM THICK INSERTS

FDA 510(k)

FDA Class 2 ·Orthopedic

ARTHREX SUTURETAK SUTURE ANCHORS

FDA 510(k)

FDA Class 2 ·Orthopedic

ARTHREX IBALANCE TKA SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

CPR TRACHEOTOMY CARE TRAY

FDA 510(k)

FDA Class 2 ·Anesthesiology

LS SERIES 200 FLOVISION SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

MSI PROCEDURE KIT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology