Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·LYNX CONTOUR CORONARY BALLOON DILATATION CATHETER(A NEW MODEL OF THE FACT CATHETER).

cobas HCV

FDA 510(k)

FDA Class 2 ·Microbiology

Aptima HCV Quant Dx Assay

FDA 510(k)

FDA Class 2 ·Microbiology

DISMOUNTED MEDICAL & SUPPLEMENTAL OXYGEN SYSTEM (DMOS)

FDA 510(k)

FDA Class 2 ·Anesthesiology

BD Intraosseous Infusion System

FDA 510(k)

FDA Class 2 ·General Hospital

AMYSYSTEMS PTS50CG 50 DEGREE WEIGHT SHIFT POWER TILT SYSTEM

FDA 510(k)

FDA Class 2 ·Physical Medicine

AMYSYSTEMS PTS50-50 DEGREE POWER TILT SYSTEM FOR MID-WHEEL OR FRONT-WHEEL DRIVE POWER WHEELCHAIRS.

FDA 510(k)

FDA Class 2 ·Physical Medicine

FibriCheck

FDA 510(k)

FDA Class 2 ·Cardiovascular

Oxehealth Vital Signs

FDA 510(k)

FDA Class 2 ·Cardiovascular

PanopticAI Vital Signs

FDA 510(k)

FDA Class 2 ·Cardiovascular

DuraGraft Vascular Conduit Solution

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Oxehealth Vital Signs

FDA 510(k)

FDA Class 2 ·Cardiovascular

Informed Vital Core Application (IVC App)

FDA 510(k)

FDA Class 2 ·Cardiovascular

FaceHeart Vitals Software Development Kit (FH vitals SDK)

FDA 510(k)

FDA Class 2 ·Cardiovascular

DuraGraft

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Vital Signs

FDA 510(k)

FDA Class 2 ·Cardiovascular

Informed Vital Core Application (IVC App) (v2.0.0.2.0.0)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Tissue Adhesive For The Topical Approximation Of Skin

FDA Pre-Market Approval

FDA Class 2 ·DERMABOND(R) TOPICAL SKIN ADHESIVE

Tissue Adhesive For The Topical Approximation Of Skin

FDA Pre-Market Approval

FDA Class 2 ·INDERMIL TISSUE ADHESIVE

Tissue Adhesive For The Topical Approximation Of Skin

FDA Pre-Market Approval

FDA Class 2 ·DERMABOND(R) TOPICAL SKIN ADHESIVE/HIGH VISCOSITY