BARTELS NEISSERIA GONORRHOEAE DIRECT FLUORESCENT

FDA 510(k)

FDA Class 2 ·Microbiology

Tissue Adhesive For The Topical Approximation Of Skin

FDA Pre-Market Approval

FDA Class 2 ·DERMABOND TOPICAL SKIN ADHESIVE

Low Ejection Fraction AI-ECG Algorithm

FDA 510(k)

FDA Class 2 ·Cardiovascular

NeuTrace EP Mapping System v.2.1

FDA 510(k)

FDA Class 2 ·Cardiovascular

JJ SKINNER CAREKITS WOUND CARE MANAGEMENT/DRESSING CHANGE TRAY

FDA 510(k)

FDA Class 2 ·General Hospital

AIMAGO EASYLDI MICROCIRCULATION CAMERA

FDA 510(k)

FDA Class 2 ·Cardiovascular

3nethra neo

FDA 510(k)

FDA Class 2 ·Ophthalmic

VISENSIA, VISENSIA WITH ALERT

FDA 510(k)

FDA Class 2 ·Cardiovascular

VFSS IMAGER, MODEL SIS-300

FDA 510(k)

FDA Class 2 ·Radiology

ARS-EKG 12K INTERPRETIVE ELECTROCARDIOGRAPHY SYST

FDA 510(k)

FDA Class 2 ·Cardiovascular

NIR BILIARY STENT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NIR BILIARY STENT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LAPASCOPIC INSTRUMENTS AND ELECTRODE TIPS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Reusable & Disposable SpO2 Sensors

FDA 510(k)

FDA Class 2 ·Cardiovascular

IPL Treatment Device (MDSQMC-01)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Single Use Micro Electrode (Brass with gold plated shaft); Single Use Micro Electrode (Stainless Steel shaft)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Single Use Arthroscopic Electrode (with Pencil)

FDA 510(k)

FDA Class 2 ·Orthopedic

SONOSENS

FDA 510(k)

FDA Class 2 ·Orthopedic

Alkaline Phosphatase

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

HARDCOVER CONDOMS MALE LATEX CONDOMS, (WITH SPERMICIDE)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology