Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·FLEXTOME CUTTING BALLOON MONORAIL

TWINHEADS TH-103 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ADD-A-SHIELD

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TWINHEADS TH-101 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

COMBO-SHIELD

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

XPRESSE INJECTION SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

COVERALL SHIELD

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

INJECTION PIN (KIP(02031-02061) (03031-03061))

FDA 510(k)

FDA Class 2 ·Orthopedic

SYSMEX SF-3000

FDA 510(k)

FDA Class 2 ·General Hospital

ADVANCED VERTEBRAL SOLUTIONS EXPRESS BFD

FDA 510(k)

FDA Class 2 ·Orthopedic

Ureteral Stents (AF-D series)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT

FDA 510(k)

FDA Class 2 ·Cardiovascular

FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Endoscopic Distal Attachment (AF-D series)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

INTERPORE CROSS INTERNATIONAL ANTERIOR FIXATION DEVICE (AFD)

FDA 510(k)

FDA Class 2 ·Orthopedic

PROTOLOGIC MODEL SER-1

FDA 510(k)

FDA Class 2 ·Anesthesiology

BIOPSY FORCEPS, (NON-RIGID)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

BIOPSY FORCEPS

FDA 510(k)

FDA Class 2 ·Cardiovascular

DYNABITE CARDIOVASCULAR BIOPSY FORCEPS

FDA 510(k)

FDA Class 2 ·Cardiovascular

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·SENOGRAPHE DS FFDM SYSTEM