AFINION ACR AND ACR CONTROL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Versius Surgical System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BCR-30-min BI™ and RBIP-ST30™ Readout Accessory

FDA 510(k)

FDA Class 2 ·General Hospital

CONTROL SERUMS FOR NONTREPONEMAL TEST

FDA 510(k)

FDA Class 2 ·Microbiology

ACR Screw System

FDA 510(k)

FDA Class 2 ·Dental

AMC R METACARPAL COMPONENT

FDA 510(k)

FDA Class 2 ·Orthopedic

ACR ENZYMATIC GLUCOSE OXIDASE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Laser treatment system , models Nyx plus, Grace plus, Nemesis, Ares

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PAINPUMP1; PAINPUMP2

FDA 510(k)

FDA Class 2 ·General Hospital

Conical Platform Dental Implants System

FDA 510(k)

FDA Class 2 ·Dental

PAINPUMP2

FDA 510(k)

FDA Class 2 ·General Hospital

LONGY Implant and LONGY-N Implant

FDA 510(k)

FDA Class 2 ·Dental

STRYKER T4 HYTREL ZIPPER TOGA

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ACR 2500 CARDIOTOMY RESERVOIR FILTER

FDA 510(k)

FDA Class 2 ·Cardiovascular

AP-6CR CINERADIOGRAPHIC FILM PROCESSOR

FDA 510(k)

FDA Class 2 ·Radiology

ACR LAB Urine Analysis Test System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MINIOX 3000 OXYGEN MONITOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

CATHEJELL S STERILE LUBRICATING JELLY

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

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