ATS SIMULUS ANNULOPLASTY BAND, MODEL 700FC

FDA 510(k)

FDA Class 2 ·Cardiovascular

Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters

FDA 510(k)

FDA Class 2 ·Cardiovascular

CLOTTRAC COAGULATION CONTROL

FDA 510(k)

FDA Class 2 ·Hematology

FIXATION STYLETS, MODELS 335-287 AND 335-288

FDA 510(k)

FDA Class 2 ·Cardiovascular

XRES BLOOD COLLECTION RESERVOIR XRES 120MICROMETER BLOOD COLLECTION RESERVOIR

FDA 510(k)

FDA Class 2 ·Cardiovascular

Sophono Bone Conduction Systems (S) Configuration and (M) Configuration

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

RECHARGEABLE BATTERY PACK FOR CRITIKON 8100 VITAL SIGNS MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

STARCERAM

FDA 510(k)

FDA Class 2 ·Dental

REAADS PROTEIN C ANTIGEN TEST KIT

FDA 510(k)

FDA Class 2 ·Hematology

KNEE MODULE FOR THE STEALTHSTATION SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

LANX SPINAL FIZATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

DIACLEAR ULTRAFILTER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

REAADS ANTI-BETA 2 GLYCOPROTEIN I IGM TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

ERCHONIA IOTO_240

FDA 510(k)

FDA Class 2 ·Physical Medicine

HEPTRAC ELECTRONIC QUALITY CONTROL

FDA 510(k)

FDA Class 2 ·Hematology

Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

ACCI-GUARD(TM) REGULAR AND PEDIATRIC HOLDER

FDA 510(k)

FDA Class 2 ·General Hospital

SHARPSCAN

FDA 510(k)

FDA Class 2 ·General Hospital

COMINED STANDARD SOLUTION

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology