XPRESSE INJECTION SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·FLEXTOME CUTTING BALLOON MONORAIL

ADD-A-SHIELD

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

COMBO-SHIELD

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

COVERALL SHIELD

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

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

SANICURE DISPOSABLE CURING PROBE

FDA 510(k)

FDA Class 2 ·Dental

WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, MODELS CFD-147-RS, CFD-247-RNS

FDA 510(k)

FDA Class 2 ·Orthopedic

WRISTJACK ORIF SYSTEM, WRISTJACK ORIF SYSTEM, NON-STERILE, MODELS CFD-347, CFD-347-NS

FDA 510(k)

FDA Class 2 ·Orthopedic

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

COAPT SYSTEMS ENDOTINE DEVICE, MODEL CFD-101-00197

FDA 510(k)

FDA Class 2 ·Orthopedic

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

FUNDUS PHOTO OPHTHALMIC DIGITAL IMAGING SYSTEM, MODEL CFD-440

FDA 510(k)

FDA Class 2 ·Ophthalmic

AGEE-WRISTJACK FRACTURE REACTION SYSTEM (STERILE VERSION), MODEL CFD-147

FDA 510(k)

FDA Class 2 ·Orthopedic

COOLAN 300

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CBC-4K HEMATOLOGY CONTROL

FDA 510(k)

FDA Class 2 ·Hematology

Elecsys AMH

FDA 510(k)

FDA Class 2 ·Clinical Chemistry