Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·M-VU ALGORITHM ENGINE

PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator

FDA 510(k)

FDA Class 2 ·General Hospital

INSPIRAID VA-1 VENTILATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

BIOFRIEND BIOMASK SURGICAL FACEMASK, MODELS UNIVERSAL BF-200-2001 AND PREMIUM BF-200-3013

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

HD Lumbar Interbody System

FDA 510(k)

FDA Class 2 ·Orthopedic

Elecsys AMH

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Elecsys TSH

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

OSW Aligner System

FDA 510(k)

FDA Class 2 ·Dental

ULE-2, MULE-2, HAND ACCESSORY KIT

FDA 510(k)

FDA Class 2 ·Physical Medicine

COMPRESSOR FILTER, MODELS AG1038831, HCF100,BF900,BF910,BF950, LL201, LL202, LL205, BACTERIA FILTER

FDA 510(k)

FDA Class 2 ·Anesthesiology

BREATHING FILTER BACTERIAL/VIRAL, MODEL AG7178

FDA 510(k)

FDA Class 2 ·Anesthesiology

Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector Cable

FDA 510(k)

FDA Class 2 ·Cardiovascular

BALDER FINESSE AND JUNIOR POWERED WHEELCHAIRS (WITH STAND-UP OPTION)

FDA 510(k)

FDA Class 2 ·Physical Medicine

Elecsys Tg II

FDA 510(k)

FDA Class 2 ·Immunology

Bakri Essential Postpartum Balloon

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Atmo Gas Capsule System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NewEra Small Dome Kit, NewEra Medium Dome Kit, NewEra Large Dome Kit

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ADVIA Centaur BR

FDA 510(k)

FDA Class 2 ·Immunology

TST - SUPPRESSOR MODEL #1000

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MONICA IF24

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology