DC-3 FLUIDS PACK, DC-5 FLUIDS PACK

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MODEL 303-42/303-43 ASPARTATE AMINOTRANSFERASE KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CK-MB ASSAY, CATALOGUE NUMBER 317-10

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·RAPIDSCREEN RS-2000

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·BRANTIGEN I/F CAGE(R) USED WITH VSP(R) SPINE PLATES AND PEDICLE SCREWS

Alternate Controller Enabled Insulin Infusion Pump

FDA classification

FDA Class 2 ·Alternate Controller Enabled Insulin Infusion Pump

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·INTER FIX THREADED FUSION DEVICE, INTER FIX RP THREADED FUSION DEVICE AND LT-CAGE LUMBAR TAPERED FUSION DEVICE

Ankle Fusion Cage

FDA classification

FDA Class 2 ·Ankle Fusion Cage

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER LX AND IMAGECHECKER DX (SOFTWARE VERSION 6.0)

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGE CHECKER M1000 SYSTEM

Monitor, Airway Pressure (Includes Gauge And/Or Alarm)

FDA Pre-Market Approval

FDA Class 2 ·NON-ABSORBABLE BLACK SILK SUTURE

Monitor, Airway Pressure (Includes Gauge And/Or Alarm)

FDA Pre-Market Approval

FDA Class 2 ·NON-ABSORBABLE BLACK SILK SUTURE

Monitor, Airway Pressure (Includes Gauge And/Or Alarm)

FDA Pre-Market Approval

FDA Class 2 ·NON-ABSORBABLE BLACK SILK SUTURE

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·RAPIDSCREEN RS-2000D

Vaporizer, Anesthesia, Non-Heated

FDA classification

FDA Class 2 ·Vaporizer, Anesthesia, Non-Heated

Apparatus, Autotransfusion

FDA classification

FDA Class 2 ·Apparatus, Autotransfusion

Dental Abutment Design Software For Dental Laboratory

FDA classification

FDA Class 2 ·Dental Abutment Design Software For Dental Laboratory

GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO2 CAPSULE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SYNERMED ISE REAGENTS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry