MAX-I-PROBE HANDPIECE

FDA 510(k)

FDA Class 1 ·Dental

GRASPING FORCEPS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SURGITEK(R) TURP MONITOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

IMPROVEMENTS TO THE MEHL RUBY LASER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SURGITEK GRADUATED CYSTOSCOPE (MODEL GC-16)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

URETERAL STENT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GUIDANT PROXIMAL SEAL SYSTEM, MODELS PSS-4500 & PS-4500

FDA 510(k)

FDA Class 2 ·Cardiovascular

IRRI-FLO IRRIGATION DELIVERY SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SURGITEK CO2 DELIVERY SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SURGITEK (R) UROFLOW SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

E.R.C.P. CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

STONE BASKET

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SURGITEK(R) LAPAROSCOPIC CHOLANGIOGRAM KIT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SURGITEK(R) 420 CM G.I. INFUSION GUIDEWIRE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)

FDA 510(k)

FDA Class 2 ·Medical Genetics

Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems

FDA 510(k)

FDA Class 2 ·Medical Genetics

Quantidex qPCR BCR-ABL IS Kit

FDA 510(k)

FDA Class 2 ·Medical Genetics

ipsogen JAK2 RGQ PCR Kit

FDA 510(k)

FDA Class 2 ·Medical Genetics

23andMe Personal Genome Service (PGS) Pharmacogenetic Reports

FDA 510(k)

FDA Class 2 ·Medical Genetics

QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System

FDA 510(k)

FDA Class 2 ·Medical Genetics