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

COAPT SYSTEMS ENDOTINE DEVICE, MODEL CFD-101-00197

FDA 510(k)

FDA Class 2 ·Orthopedic

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

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

PRO-GLASS

FDA 510(k)

FDA Class 2 ·Dental

BLASTOMYCES/ANTIGEN FOR IMMUNODIFUSION

FDA 510(k)

FDA Class 2 ·Microbiology

IMMUNODIFFUSSION REAGENTS/SEROLOGICAL

FDA 510(k)

FDA Class 2 ·Microbiology

BLASTOMYCES DERMATITIDIS, ANTIGEN

FDA 510(k)

FDA Class 2 ·Microbiology

HEMOTEC CV WHOLE BLOOD COAGULATION CONTROLS

FDA 510(k)

FDA Class 2 ·Hematology

HEMOTEC CITRATED WHOLE BLOOD COAGULATION CONTROLS

FDA 510(k)

FDA Class 2 ·Hematology

HEMOTEC ACT I SYSTEM

FDA 510(k)

FDA Class 2 ·Hematology

EMERGENT TECHNOLOGY VENTILATORY EFFORT MONITOR VEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

ADDITIONAL HEMOTEC HEPCON/SYS B-10 COAGULATION CAR

FDA 510(k)

FDA Class 2 ·Hematology

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER CAD