RITC-ANTI HUMAN IGA, IGG, KAPPA, LAMBDA

FDA 510(k)

FDA Class 2 ·Immunology

iHealth COVID-19 Antigen Rapid Test

FDA 510(k)

FDA Class 2 ·Microbiology

CRYOLYZER ALPHA (CRYOSURG.EQUIP.)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN ESTROGEN RECE[PTOR ANTIBODY (CLONE SP1)

FDA 510(k)

FDA Class 2 ·Hematology

eMurmur Heart AI

FDA 510(k)

FDA Class 2 ·Cardiovascular

Formus Hip

FDA 510(k)

FDA Class 2 ·Radiology

Rune Labs Tremor Transducer System

FDA 510(k)

FDA Class 2 ·Neurology

CADWELL DISPOSABLE MONOPOLAR / BIPOLAR / CONCENTRIC / FLUSH TIP /BALL TIP PEDICLE SCREW STIMULATOR PROBE,

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

DR. GOULD HAND PACK SUSTOM STERIL

FDA 510(k)

FDA Class 2 ·General Hospital

iCare APP

FDA 510(k)

FDA Class 2 ·Cardiovascular

DIA SCREEN 10 WAY REAGENT STRIPS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Disposable Syringe with permanently attached needle, Safety Syringe with permanently attached needle

FDA 510(k)

FDA Class 2 ·General Hospital

Clavicle and Scapula System

FDA 510(k)

FDA Class 2 ·Orthopedic

BAUSCH & LOMB SOFLENS MULTIFOCAL (POLYMACON) VISIBILITY TINTED CONTACT LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, MODELS CFD-147-RS, CFD-247-RNS

FDA 510(k)

FDA Class 2 ·Orthopedic

HBL Blade Assembly

FDA 510(k)

FDA Class 2 ·Orthopedic

CALCIUM REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Clearform Aligners

FDA 510(k)

FDA Class 2 ·Dental

EndeavorOTC

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ScioCardio ECG Transmitter

FDA 510(k)

FDA Class 2 ·Cardiovascular