ITC HEARING AID CLUB MODEL LM50

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LAXIMA INTERNATIONAL LIMITED SUNGLASSES

FDA 510(k)

FDA Class 1 ·Ophthalmic

CLICK-ON

FDA 510(k)

FDA Class 2 ·General Hospital

ELLIPSE 12PL, MODEL 9ESL7228

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MIL CM-II COAGULATION MACHINE

FDA 510(k)

FDA Class 2 ·Hematology

Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection); Ambu® aBox™ 2

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DISPOSABLE SURGICAL MASK (MODIFIED)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

F183 AC-MINI MASSAGER WITH UL APROVED ADAPTOR

FDA 510(k)

FDA Class 1 ·Physical Medicine

RTX3320PSTN WIRELESS TELEHEALTH GATEWAY

FDA 510(k)

FDA Class 2 ·Cardiovascular

NICU V'02

FDA 510(k)

FDA Class 2 ·Anesthesiology

PATIENT EXAMINATION GLOVES (LATEX)

FDA 510(k)

FDA Class 1 ·General Hospital

35/CD CINECONVERTER

FDA 510(k)

FDA Class 2 ·Radiology

FRAME, SPECTACLE

FDA 510(k)

FDA Class 1 ·Ophthalmic

SUNGLASSES AND SPECTACLE FRAMES

FDA 510(k)

FDA Class 1 ·Ophthalmic

AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ELLIPSE JUVIA, MODEL 9EJU7465

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Innonix Antiviral Child's Face Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MiniMed Mio Advance infusion set

FDA 510(k)

FDA Class 2 ·General Hospital