EDGE

FDA 510(k)

FDA Class 2 ·Radiology

UNICAP 100

FDA 510(k)

FDA Class 2 ·Immunology

Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative Plan, SmartBase for Arthrex Glenoid IRIS, ArthrexVIP Web Portal

FDA 510(k)

FDA Class 2 ·Orthopedic

MAMMOTOME HAND HELD PROBE, MODEL MHH8

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6800); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6900)

FDA 510(k)

FDA Class 2 ·General Hospital

CHECKPOINT

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

RANGER-X

FDA 510(k)

FDA Class 2 ·Physical Medicine

HERCO SILICONE RESUSCITATOR OR SUN-MED RESUSCITA.

FDA 510(k)

FDA Class 2 ·Anesthesiology

1.5T 12 CHANNEL BODY ARRAY

FDA 510(k)

FDA Class 2 ·Radiology

Indego

FDA 510(k)

FDA Class 2 ·Physical Medicine

AMSCO CHIMERON MEDIUM STEAM STERILIZER

FDA 510(k)

FDA Class 2 ·General Hospital

AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH1); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH2); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO1); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2); AtriClip PRO-V LAA Exclusion System (PROV); AtriClip Flex-V LAA Exclusion System with preloaded V Clip (ACHV)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DUAL-TEMP(TM) COOLING/WARMING UNIT

FDA 510(k)

FDA Class 2 ·Physical Medicine

ONE TRAY® Sealed Sterilization Container System

FDA 510(k)

FDA Class 2 ·General Hospital

SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE

FDA 510(k)

FDA Class 2 ·Microbiology

MEHTA BRONCHIAL BIOSPY DRILL

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

HydroMARK Breast Biopsy Site Marker

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

VARIOUS CAMEO MED BASIC BIOPSY TRAYS, DISPOSABLE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SENSE BODY COIL

FDA 510(k)

FDA Class 2 ·Radiology