SCOOTA MOTORIZED VEHICLE

FDA 510(k)

FDA Class 2 ·Physical Medicine

TARGA (WHEELCHAIR)

FDA 510(k)

FDA Class 2 ·Physical Medicine

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·COOK MBC PTCA BALLOON DILATATION CATHETER

BOND-IT DUAL CURE ACTIVATOR

FDA 510(k)

FDA Class 2 ·Dental

MYO-ACTUATOR

FDA 510(k)

FDA Class 2 ·Neurology

CORDIS STEERABLE GUIDEWIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

NG-Test CARBA 5

FDA 510(k)

FDA Class 2 ·Microbiology

RAPIDEC CARBA NP

FDA 510(k)

FDA Class 2 ·Microbiology

NG-Test® CTX-M MULTI

FDA 510(k)

FDA Class 2 ·Microbiology

VIDAMED 50 ELECTROSURGICAL GENERATOR, VIDAMED AEC (ADJUSTABLE ELECTROSURGICAL CARTRIDGE) ACCESSORY

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FilmArray Respiratory Panel 2 plus (RP2plus)

FDA 510(k)

FDA Class 2 ·Pathology

NOVA CO-OXIMETER ANALYZER

FDA 510(k)

FDA Class 2 ·Hematology

NOVA 16 ANALYZER (MODIFICATION POINT OF CARE USAGE)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

STAT PROFILE ULTRA 11 ANALYZER (MODIFICATION)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

STAT PROFILE PHOX ANALYZER

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

STAT PROFILE PHOX CO-OXIMETER ANALYZER, NOVA CO-OXIMETER CONTROLS, LEVELS 1 AND 2, NOVA CO-OXIMETER THB CALIBRATOR

FDA 510(k)

FDA Class 2 ·Hematology

EC50 MICRO+ SMOKERLYZER

FDA 510(k)

FDA Class 2 ·Anesthesiology

Integrity V500 (Integrity, Integrity with VEMP)

FDA 510(k)

FDA Class 2 ·Neurology

VIVOSONIC NEUROSCREEN

FDA 510(k)

FDA Class 2 ·Neurology

SAM CRRT Unit, SAM Cassette CRRT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology