SENTRY OTC MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

HONEYWELL HOMMED CENTRAL STATION 4.0

FDA 510(k)

FDA Class 2 ·Cardiovascular

GENESIS TOUCH SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

UNIVERSAL SELF-ALIGNING ACETABULAR COM

FDA 510(k)

FDA Class 2 ·Orthopedic

BLOM-SINGER TRACHEOESOPHAGEAL PUNCTURE SET

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

E-COM DR-2000 DR

FDA 510(k)

FDA Class 2 ·Radiology

DISPOSABLE BLOOD PRESSURE TRANSDUCER DOM

FDA 510(k)

FDA Class 2 ·Cardiovascular

LNCS AND SPO2.COM SENSORS

FDA 510(k)

FDA Class 2 ·Cardiovascular

BLOM-SINGER DUCKBILL VOICE PROSTHESIS

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

KIN-COM ASYMMETRICAL BACK SYSTEM

FDA 510(k)

FDA Class 2 ·Physical Medicine

BLOM-SINGER INDWELLING TEP OCCLUDER

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TEST

FDA 510(k)

FDA Class 2 ·Immunology

XPERT MTB/RIF ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

Uni-port

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80

FDA 510(k)

FDA Class 2 ·Microbiology

MEROCEL(R) LASER-GUARD(TM)

FDA 510(k)

FDA Class 2 ·Anesthesiology

Xpert Norovirus, GeneXpert Dx Systems (GX-I, GX-11, GX-IV, GX-XVI), GeneXpert Infinity-48 System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System

FDA 510(k)

FDA Class 2 ·Microbiology

Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpertInfinity-80 systems), Xpert Vaginal/Endocervical Specimen Collection Kit, and Xpert Urine Specimen Collection Kit

FDA 510(k)

FDA Class 2 ·Immunology

XPERT FLU GENEXPERT DX SYSTEMS (GX-I, GX-IV)

FDA 510(k)

FDA Class 2 ·Microbiology

XPERT FLU, GENEXPERT DX SYSTEMS, GENEXPERT INFINITY SYSTEM, GENEXPERT SYSTEM SOFTWARE VERISIONS 2.1 AND 4.0

FDA 510(k)

FDA Class 2 ·Microbiology