URS-1B (BLOOD TEST)

FDA 510(k)

FDA Class 2 ·Hematology

WIENER LAB. URINE STRIP 10 AND 11

FDA 510(k)

FDA Class 2 ·Hematology

BACTIDROP(TM) LACTOPHENOL ANILINE BLUE

FDA 510(k)

FDA Class 2 ·Hematology

URITEST 10G & 11G URINE REAGENT STRIPS AND URITEST-50 AND URITEST-500B URINE ANALYZERS

FDA 510(k)

FDA Class 2 ·Hematology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·BOSTON SCIENTIFIC SCIMED MAVERICK(TM) OVER-THE-WIRE

INFUSION SET

FDA 510(k)

FDA Class 2 ·General Hospital

FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Kentrospine PSS Pedicle Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

MEDSYNAPSE Zero Footprint Viewer

FDA 510(k)

FDA Class 2 ·Radiology

CEPTRE® Knotted UHMWPE Suture PEEK Anchor

FDA 510(k)

FDA Class 2 ·Orthopedic

Smart Scope® CX

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

FORCEPS, SURGICAL, GYNECOLOGICAL

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Thulium Fiber Laser (FiberLAZE+, FiberLAZE)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Varixis Elbow System

FDA 510(k)

FDA Class 2 ·Orthopedic

INVIGRA MALE LATEX CONDOM YELLOW COLORED AND BANANA FLAVORED

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE Vanilla

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

INFILOOP® Fixed Loop UHMWPE Suture Titanium Button

FDA 510(k)

FDA Class 2 ·Orthopedic

DentCare Aligners

FDA 510(k)

FDA Class 2 ·Dental

Latitud Hip Replacement System

FDA 510(k)

FDA Class 2 ·Orthopedic

Monik™ - Disposable Endoscopic Trocar

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology