CBR-T3RIA KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CBR-DIGOXIN ANTISERUM

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Yxoss CBR®

FDA 510(k)

FDA Class 2 ·Dental

CBR-T3 UPTAKE KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

N20 TEST

FDA 510(k)

FDA Class 2 ·Anesthesiology

OSCAR(TM) II CAPNOMETER & PULSE OXIMETER

FDA 510(k)

FDA Class 2 ·Anesthesiology

SPEACELABS MULTIGAS MODULE

FDA 510(k)

FDA Class 2 ·Anesthesiology

SPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·Anesthesiology

SPACELABS MEDICAL MULTIGAS ANALYZER

FDA 510(k)

FDA Class 2 ·Anesthesiology

BubbleView™ Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-CBR); ViewHub® Video Processor (S13, S13-T, S13-N, S13-S)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)

FDA classification

FDA Class 2 ·Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)

Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck OAE+ABR, Otocheck OAE+ABR LE, Otocheck ABR Screener-Otodynamics ABR Upgrade Kit

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

ABR-2000

FDA 510(k)

FDA Class 2 ·Neurology

AUDIOSCREENER OAE + ABR

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

AUDIOSCREENER OAE+ABR

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

COMPUTERSCOPE CPS-ABR

FDA 510(k)

FDA Class 2 ·Neurology

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

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

FDA 510(k)

FDA Class 2 ·Medical Genetics

BCR-ABL1 (p210) % IS Kit (Digital PCR Method)

FDA 510(k)

FDA Class 2 ·Medical Genetics