INTERPORE CYLINDRICAL HEX IMPLANT, 3.3 MM DIAMETER

FDA 510(k)

FDA Class 2 ·Dental

TRANSFERRIN RID KIT

FDA 510(k)

FDA Class 2 ·Immunology

ULTRACINCH ABLATION DEVICE, ULTRACINCH ACCESSORY PACK, MODELS UC-8, UC-9, UC-10, UC-11, UC-12, UC-13, UC-14, UC-ACC-1

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NEMIO DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-550A

FDA 510(k)

FDA Class 2 ·Radiology

ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA

FDA 510(k)

FDA Class 2 ·Microbiology

ANNULUS DISPOSABLE VALVULOTOME

FDA 510(k)

FDA Class 2 ·Cardiovascular

ZODIAC 4.0 POLYAXIAL SPINAL FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

STORZ MODULITH LITHOTRIPTER SLX-F2-F180

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CHEMTRUE SINGLE / MULTI DRUG SCREEN CASSETTE / DIP CARD TESTS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASER

FDA 510(k)

FDA Class 2 ·Ophthalmic

MEDISIGN BLOOD GLUCSE MONITORING SYSTEM, MEDISIGN MULTI BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

HAPTITE COATING IMPLANT SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

LSVP INTERNATIONAL BIOPSY FORCEPS

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

QUICKSTRIP ONE STEP OPIATES TEST

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

OPTILASE YAG MODEL 1000

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit (MOL3950, MOL3960, MOL5390)

FDA 510(k)

FDA Class 2 ·Microbiology

Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set

FDA 510(k)

FDA Class 2 ·Microbiology

IMMUNO DOT BORRELIA DOT BLOT G TEST

FDA 510(k)

FDA Class 2 ·Microbiology

BECHLER MEDICAL, MODEL 5000,THE WIZ HOLTER SCANNER

FDA 510(k)

FDA Class 2 ·Cardiovascular

A-TENS - MODEL AI-87

FDA 510(k)

FDA Class 2 ·Neurology