COBAS FP REAGEN FOR PRIMIDONE & PRIMI CALIBRATORS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

PERFSCAPE

FDA 510(k)

FDA Class 2 ·Radiology

FRANKENMAN SURGICAL STAPLERS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch

FDA 510(k)

FDA Class 2 ·Cardiovascular

MH1 MICROHOLTER RECORDER

FDA 510(k)

FDA Class 2 ·Cardiovascular

BTL-08 ECG RECORDER MODEL BTL-08 ECG LC PLUS, BTL-08 ECG LT PLUS

FDA 510(k)

FDA Class 2 ·Cardiovascular

Genesys Spine AIS-C II Cervical Interbody Fusion System

FDA 510(k)

FDA Class 2 ·Orthopedic

Genesys Spine Binary® Lumbar Plate System

FDA 510(k)

FDA Class 2 ·Orthopedic

COBAS FP REAGEN FOR AMIKACIN & AMIKACIN CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Disposable Medical Face Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TrainFES Advance

FDA 510(k)

FDA Class 2 ·Physical Medicine

GENESYS SPINE INTERBODY FUSION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

NIM PAK Needle; NIM XPAK Needle; NIM Pedicle Probe

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

D2P

FDA 510(k)

FDA Class 2 ·Radiology

MORPHINE ROCHE (R) EIA TEST

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

REVISED LABELING FOR BENZODIAZEPINE TEST KIT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

REVISED LABELING FOR COCAINE/COCAINE META. TEST

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ROCHE REAGENT FOR CHLORIDE, FOR THE COBAS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BITTAR ZIRCONIA BLOCKS

FDA 510(k)

FDA Class 2 ·Dental

PVMED DDR 2520 DIGITAL IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology