TEMPORARY PACEMAKER ELECTRODE

FDA 510(k)

FDA Class 2 ·Cardiovascular

TB SERIES BIPOLAR PACING LEADS

FDA 510(k)

FDA Class 2 ·Cardiovascular

HATCHER STONE EXTRACTOR - DISPOSABLE CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Flosteril Poly-reinforced Isolation Gowns Model 8120 (Catalogue Number 8120400), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120410), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120430), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120450), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120460)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MI-328, MI-316, MI-388 DIGITAL THERMOMETER

FDA 510(k)

FDA Class 2 ·General Hospital

GYRUS ENDOUROLOGY SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GYRUS HYSTEROSCOPIC RESECTOSCOPE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE ELECTRODE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE LOOP ELECTRODE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GYRUS G3 SYSTEM (GENERATOR, ASSESSORIES, SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189))

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PLASMAKINETIC ENDOUROLOGY SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

handLITE (TN19S)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

décoLITE LED Device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

GYRUS HYSTEROSCOPIC RESECTOSCOPE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MULTIBOLUS II DISPOSABLE PAIN MANAGEMENT SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

MODIFICATION TO ANIMEC, MODELS AM-2S-4, AM-2S-5, LT-1-4 & LT-1-5

FDA 510(k)

FDA Class 2 ·General Hospital

TOMEY PE-300 PORTABLE ERG

FDA 510(k)

FDA Class 2 ·Ophthalmic

PANORAMIC LOUPES - VARIOUS

FDA 510(k)

FDA Class 2 ·Ophthalmic

URINE NEGATIVE CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Toxicology