GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL

FDA 510(k)

FDA Class 2 ·Hematology

SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option

FDA 510(k)

FDA Class 2 ·Radiology

Philips Multislice CT System with Low Dose CT Lung Cancer

FDA 510(k)

FDA Class 2 ·Radiology

BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN, BECKMAN COULTER

FDA 510(k)

FDA Class 2 ·Immunology

MININEPH A-1 ANTITRYPSIN ANTISERUM, HIGH AND LOW SERUM CONTROLS

FDA 510(k)

FDA Class 2 ·Immunology

SYNCHRON SYSTEMS DAT MULTI-DRUG LOW AND HIGH URINE CALIBRATORS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ARCHITECT T-UPTAKE CALIBRATORS (A-F) AND CONTROLS (LOW, HIGH)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

WHITESIDE BIOMECHANICS TITANIUM LOW-PROFILE CABLE, MODEL BIO-1-1013

FDA 510(k)

FDA Class 2 ·Orthopedic

ULTRA LOW TOTAL CHLORINE, E-Z CHEK SENSITIVE TOTAL CHLORINE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MININEPH A-1 TRANSFERRIN ANTISERUM, HIGH AND LOW SERUM CONTROL

FDA 510(k)

FDA Class 2 ·Immunology

BIRD SENTRY BLENDER/ ANALYZER / BIRD SENTRY LOW FLOW BLENDER/ANALYZER

FDA 510(k)

FDA Class 2 ·Anesthesiology

SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option

FDA 510(k)

FDA Class 2 ·Radiology

9TH WAVE MODELS 500 & 550 LOW AIR LOSS SYSTEMS

FDA 510(k)

FDA Class 2 ·General Hospital

LOW PROFILE PASSPORT PUSH & PULL KITS & PEG TUBE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AMSCO V-PRO 1 LOW/PLUS/MAX TEMPERATURE STERILIZATION SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2407

FDA 510(k)

FDA Class 2 ·Neurology

STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS)

FDA 510(k)

FDA Class 2 ·General Hospital

Rho

FDA 510(k)

FDA Class 2 ·Radiology

Catheter, Angioplasty, Peripheral, Transluminal

FDA Pre-Market Approval

FDA Class 2 ·FLEXTOME CUTTING BALLOON MONORAIL(MR)/OVER THE WIRE(OTW)

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MAVERICK OTW, MAVERICK MONORAIL & MAVERICK2 MONORAIL PTCA CATHETERS