QUICKVUE ONE-STEP HCG-URINE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TENSYN BAND

FDA 510(k)

FDA Class 2 ·Orthopedic

cNEP Airway

FDA 510(k)

FDA Class 2 ·Anesthesiology

PUREGRAFT 850/PURE SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PSI SKULL CLAMP

FDA 510(k)

FDA Class 2 ·Neurology

STRYKER LED LIGHTSOURCE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SAS SALMONELLA H T ANTISERUM

FDA 510(k)

FDA Class 2 ·Microbiology

MEMOGRAPH STAPLE, WARM SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

MEDACTA BIPOLAR HEAD

FDA 510(k)

FDA Class 2 ·Orthopedic

UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses

FDA 510(k)

FDA Class 2 ·Ophthalmic

RUBICOR BREAST BIOPSY DEVICE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable Contact Lens with UV Blocker

FDA 510(k)

FDA Class 2 ·Ophthalmic

QardioArm 2

FDA 510(k)

FDA Class 2 ·Cardiovascular

SIEMENS VIRTUAL SIMULATION (VSIM)

FDA 510(k)

FDA Class 2 ·Radiology

TRITEST REAGENT CD3 FITC/CD19 PE/CD45 PERCP

FDA 510(k)

FDA Class 2 ·Hematology

KTP/532 SURGICAL LASER FOR PERCUTANEOUS DISKECTOMY

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EMIT IIC BARBITURATE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

FASCOUNT SYSTME

FDA 510(k)

FDA Class 2 ·Hematology

SE INFUSION SYSTEM WITH MMS

FDA 510(k)

FDA Class 2 ·General Hospital