KRONUS IA-2 AUTOANTIBODY RIA ASSAY KIT

FDA 510(k)

FDA Class 2 ·Immunology

KAY-PLUS & VARIOUS VANIA SANITARY LINERS & PADS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

PRE-POWDERED NITRILE EXAMINATION GLOVES

FDA 510(k)

FDA Class 2 ·Orthopedic

ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R

FDA 510(k)

FDA Class 2 ·Anesthesiology

EXPD 4343S

FDA 510(k)

FDA Class 2 ·Radiology

STERILE INSULIN PEN NEEDLE

FDA 510(k)

FDA Class 2 ·General Hospital

Geniant Cranial (Navigated Neurosurgical Positioning Robot)

FDA 510(k)

FDA Class 2 ·Neurology

Highness Implant System

FDA 510(k)

FDA Class 2 ·Dental

HFT750U

FDA 510(k)

FDA Class 2 ·Anesthesiology

VIVA combo RF System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EXULT Knee Replacement System

FDA 510(k)

FDA Class 2 ·Orthopedic

Neo Cosmo (Polymacon) Soft (Hydrophilic) Contact Lens

FDA 510(k)

FDA Class 2 ·Ophthalmic

EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXPD 3643N; EXPD 3643U1; EXPD 3643NU; EXPD 3643NP

FDA 510(k)

FDA Class 2 ·Radiology

Esophageal TTS Stent

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EXULT Knee Replacement System

FDA 510(k)

FDA Class 2 ·Orthopedic

URUS System (DMG-SU100/URUS); URUS System (DMG-SU100R/URUS); URUS System (VP-100/Video Processor)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Onycho Laser V

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EXULT Knee Replacement System

FDA 510(k)

FDA Class 2 ·Orthopedic

TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)

FDA 510(k)

FDA Class 2 ·Ophthalmic