MRDx BCR-ABL Test, MRDx BCR-ABL Test Software

FDA 510(k)

FDA Class 2 ·Medical Genetics

Electric Wheelchair (Robooter E60) (BBR-E60-01); Electric Wheelchair (Robooter E60) (BBR-E60-02); Electric Wheelchair (Robooter E60) (BBR-E60-03); Electric Wheelchair (Robooter E60) (BBR-E60-04); Electric Wheelchair (Robooter E60) (BBR-E60-05); Electric Wheelchair (Robooter E60) (BBR-E60-06); Electric Wheelchair (Robooter E60) (BBR-E60-07); Electric Wheelchair (Robooter E60) (BBR-E60-08)

FDA 510(k)

FDA Class 2 ·Physical Medicine

STACKED ABR FOR NAVIGATOR PRO

FDA 510(k)

FDA Class 2 ·Neurology

Balloon Catheter and Balloon Ureteral Dilator Set

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Navident

FDA 510(k)

FDA Class 2 ·Dental

DYNASOUND MODEL 401 THERAPEUTIC ULTRASOUND STIMULATOR

FDA 510(k)

FDA Class 2 ·Physical Medicine

Laser Ureteral Catheter

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

One-Step Suprapubic Introducer

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Safety Wire Guide Introducer

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Cook 810 Set, Desilets-Hoffman Introducer Set

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex, EchoTip Open-End Ureteral Catheter, Open-End Flexi-Tip Ureteral Catheter, Flexi-Tip Ureteral Catheter (Closed End), Whistle Tip Ureteral Catheter, Round Tip Ureteral Catheter, Spiral Tip Ureteral Access Catheter, Pediatric Ureteral Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Kosmos

FDA 510(k)

FDA Class 2 ·Radiology

THE SCREENER GSI 55 ABR SCREENER

FDA 510(k)

FDA Class 2 ·Neurology

INTERACOUSTICS EP 15 ABR STAND ALONE UNIT

FDA 510(k)

FDA Class 2 ·Neurology

ACON ONE STEP PREGNANCY TEST STRIP (URINE)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACON THC ONE STEP MARIJUANA TEST STRIP(URINE);ACON THC ONE STEP MARIJUANA TEST DEVICE (URINE)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Canary Tibial Extension with Canary Health Implanted Reporting Processor (CHIRP) System

FDA 510(k)

FDA Class 2 ·Orthopedic

ACON ONE STEP HOME PREGNANCY TEST STRIP

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACON HCG ONE STEP PREGNANCY TEST DEVICE (URINE)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry