SCoV-2 Ag Detect Rapid Test

FDA 510(k)

FDA Class 2 ·Microbiology

CU-75 VISIBLE LIGHT-CURING UNIT

FDA 510(k)

FDA Class 2 ·Dental

MASKS SURGICAL DENTAL

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EUROIMMUN EUROLINE PROFILE AUTOIMMUNE LIVER DISEASE 8AG (IGG)

FDA 510(k)

FDA Class 2 ·Immunology

IDECAP DIALYZER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ASTar BC G- Kit and ASTar Instrument

FDA 510(k)

FDA Class 2 ·Microbiology

ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+

FDA 510(k)

FDA Class 2 ·Radiology

ScandiDos Delta4 Phantom+

FDA 510(k)

FDA Class 2 ·Radiology

Delta4 Insight

FDA 510(k)

FDA Class 2 ·Radiology

Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW)

FDA 510(k)

FDA Class 2 ·Radiology

DiviTum TKa

FDA 510(k)

FDA Class 2 ·Immunology

COMPUTER - COMPUTERS AND SOFTWARE, MEDICAL USE

FDA 510(k)

FDA Class 2 ·General Hospital

DIAGNOSTIC ULTRASOUND SYSTEM TYPE 3535

FDA 510(k)

FDA Class 2 ·Radiology

ANESTHETIC GAS MONITOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

ANESTHETIC GAS MONITOR TYPE 1304, MODIFIED

FDA 510(k)

FDA Class 2 ·Anesthesiology

BIOPSY FIXATION UNIT-TYPE UA 0997

FDA 510(k)

FDA Class 2 ·Radiology

DIAGNOSTIC ULTRASOUND SYSTEM TYPE 3535, MODIFIED

FDA 510(k)

FDA Class 2 ·Radiology

IN SITU EAR GAIN AUDIO TEST STAT TYPE 2118/WH 1823

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

CARBON DIOXIDE & OXYGEN MONITOR TYPE 1308

FDA 510(k)

FDA Class 2 ·Anesthesiology

RIGID ENDOSCOPE

FDA 510(k)

FDA Class 2 ·Radiology