EXETER X3 RIMFIT ACETABULAR CUP

FDA 510(k)

FDA Class 2 ·Orthopedic

Radio Frequency System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

HOFFMANN 3

FDA 510(k)

FDA Class 2 ·Orthopedic

T2 TIBIAL NAILING SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

VARIAX 2 COMPRESSION PLATING SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

HOFFMANN LRF (LIMB RECONSTRUCTION FRAME SYSTEM)

FDA 510(k)

FDA Class 2 ·Orthopedic

DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

REUNION RSA SHOULDER SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Denture Base Resin (PN-Denture (Red, White))

FDA 510(k)

FDA Class 2 ·Dental

Air compression massager (ACM-PLUS-A1, ACM-PLUS-A2, ACM-PLUS-A3, ACM-PLUS-A4, ACM-PLUS-A5, ACM-PLUS-A6)

FDA 510(k)

FDA Class 2 ·Physical Medicine

VARIAX 2 SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging System

FDA 510(k)

FDA Class 2 ·Radiology

VARIAX 2 SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

VARIAX 2 ONE THIRD TUBULAR PLATING SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL)

FDA 510(k)

FDA Class 2 ·Radiology

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·ENZYMUN TEST{R} CEA

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·CEA-ROCHE TEST KIT

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·CEA-ROCHE(R) EIA

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT CEA-EIA KIT