SOURCERER

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

FLEXILOG 2000

FDA 510(k)

FDA Class 1 ·Gastroenterology, Urology

FLEXILOG LS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FLEXILOG LS 13921

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FLEXILOG 3000

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CARDIOSCINT (LEFT VENTRICULAR FUNCTION MONITOR)

FDA 510(k)

FDA Class 1 ·Radiology

FLEXILOG 1010 AMBULATORY PH MONITORING SYSTEM

FDA 510(k)

FDA Class 1 ·Gastroenterology, Urology

F.A.S.T. SYSTEM SED AND CXD

FDA 510(k)

FDA Class 2 ·Cardiovascular

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC MODEL 7221 B/C/CX/D/E MICRO JEWEL W/MODEL 5434 ACTIVE CAN EMULATOR AND MODEL 9894

LONG EXACT CALCAR PLANAR - FXD

FDA UDI

Zimmer, Inc.·00889024649378·

AngelMed Guardian EXD Carrying Case

FDA UDI

Angel Medical Systems, Inc.·00850012625049·EXD Carrying Case

SONICflex cari-ex D Tipset

FDA UDI

KaVo Dental GmbH·EKAV100073780·

ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)

FDA 510(k)

FDA Class 2 ·Cardiovascular

ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)

FDA 510(k)

FDA Class 2 ·Cardiovascular

DX-D FULL LEG FULL SPINE

FDA 510(k)

FDA Class 2 ·Radiology

IMPlate

FDA UDI

SKELETAL DYNAMICS L.L.C.·00841506102061·

Geminus

FDA UDI

SKELETAL DYNAMICS L.L.C.·00841506105406·

Geminus

FDA UDI

SKELETAL DYNAMICS L.L.C.·00841506102078·

Geminus

FDA UDI

SKELETAL DYNAMICS L.L.C.·00841506102108·

DX-D Imaging Package with XD Detectors

FDA 510(k)

FDA Class 2 ·Radiology