MODIFICATION TO THERMAGE THERMACOOL SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SPI ART ABUTMENT

FDA 510(k)

FDA Class 2 ·Dental

ECARD AND CCARD

FDA 510(k)

FDA Class 2 ·Cardiovascular

HALO360 ENERGY GENERATOR, MODELS 1100C-115B AND 1100C-230B

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MODIFICATION TO MEDRAD 8-RECEIVER PHASED ARRAY NEUROVASCULAR COIL FOR SIEMENS

FDA 510(k)

FDA Class 2 ·Radiology

BUPRENORPHINE ENZYME IMMUNOASSAY WITH NORBUPRENORPHINE CALIBRATORS AND CONTROLS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

TARGON FN SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

QUICKSCREEN COCAINE 150 SCREENING TEST

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

LAMINAR FLOW PHACO TIPS

FDA 510(k)

FDA Class 2 ·Ophthalmic

LH 450 ENTERAL FEEDING BAG PUMP SET W/INTEGRATED Y-PORT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

IMMUNALYSIS TRAMADOL URINE ENZYME IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

KOMPRESSOR SCREW SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

PEREGRINE ILLUMINATING LASER PROBE MODEL PD600.10

FDA 510(k)

FDA Class 2 ·Ophthalmic

METHADONE METABOLITE (EDDP) ENZIME IMMUNOASSAY, CAT. NO. 190 (500 TEST KIT), NO. 191 (5000 TEST KIT)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Indigo® Aspiration System – Lightning Bolt Aspiration Tubing

FDA 510(k)

FDA Class 2 ·Cardiovascular

Control-IQ+ technology

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion device with interfixation; aprevo® transforaminal lumbar interbody fusion device; aprevo® TLIF-CA Articulating System; aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X No Cams

FDA 510(k)

FDA Class 2 ·Orthopedic

VENTREX OXYGEN SENSOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

CHAD TOTAL O2 DELIVERY SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER KIT AND SET

FDA 510(k)

FDA Class 2 ·Anesthesiology