INSERTION GAIN OPTIMIZER IGO-1000

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

VR101 Lubricating Intravaginal Ring

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Nellcor EASYCAP II Adult Colorimetric CO2 Detector, Nellcor PEDCICAP Pediatric Colorimetric CO2 Detector

FDA 510(k)

FDA Class 2 ·Anesthesiology

TeleScan

FDA 510(k)

FDA Class 2 ·Radiology

Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1)

FDA 510(k)

FDA Class 2 ·Neurology

M-56 GOLD BASE DENTAL ALLOY

FDA 510(k)

FDA Class 2 ·Dental

Pulpdent Solo Flowable Composite with MCP

FDA 510(k)

FDA Class 2 ·Dental

AIRO Computed Tomography (CT) X-ray System

FDA 510(k)

FDA Class 2 ·Radiology

CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1001

FDA 510(k)

FDA Class 2 ·Cardiovascular

SPIRA Open Matrix ALIF

FDA 510(k)

FDA Class 2 ·Orthopedic

VALIDATE D-Dimer Calibration Verification / Linearity Test Kit

FDA 510(k)

FDA Class 2 ·Hematology

Climax Personal Lubricant

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit

FDA 510(k)

FDA Class 2 ·Microbiology

URISTRIP REAGENT STRIPS TEST FOR PROTEIN, GLUCOSE, PH AND BLOOD

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BIOSTRIP(R) HCG-ONE STEP PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MEDELAS BREAST PUMP

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ADVANCED AUTOMATIC KV

FDA 510(k)

FDA Class 2 ·Radiology

KARL STORZ PEDIATRIC VANCAILLIE TAKE-APART BIPOLAR MICRO-FORCEPS, MANHES TAKE-APART BIPOLAR FORCEPS, VBIPOLAR COAGULATEE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CASCASE 480 SNSLYZER

FDA 510(k)

FDA Class 2 ·Hematology