MODEL FP-100

FDA 510(k)

FDA Class 2 ·Radiology

RE-ENTRANT CHAMBER

FDA 510(k)

FDA Class 2 ·Radiology

PATIENT PREOPERATIVE PREP TRAY, SINGLE USE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PALGARAPID

FDA 510(k)

FDA Class 2 ·Dental

Teleport Microcatheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Critical Alert CommonPath Enterprise

FDA 510(k)

FDA Class 2 ·Cardiovascular

Arthrex FiberTak Suture Anchor

FDA 510(k)

FDA Class 2 ·Orthopedic

DEVMED STEPPING AND STABILIZING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

CALYSTO SERIES IV PATIENT CARE MONITORS AND CENTRAL STATION AND ECG MANAGEMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

EARSCAN 3

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Kalitec Navigated Instrument System

FDA 510(k)

FDA Class 2 ·Neurology

RNS STERILE DISPOSABLE PUNCTURE TRAY

FDA 510(k)

FDA Class 2 ·General Hospital

METACARPAL FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

INTRICON DATRIX SIRONA EVENT/ HOLTER RECORDER

FDA 510(k)

FDA Class 2 ·Cardiovascular

SHOULDER FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

FlareHawk Interbody Fusion System

FDA 510(k)

FDA Class 2 ·Orthopedic

Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Myopia and Hyperopia; Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Astigmatism

FDA 510(k)

FDA Class 2 ·Ophthalmic

AUTO-INJECTOR, SURE-INJECT 2000

FDA 510(k)

FDA Class 2 ·General Hospital

ZEFON ADULT ANESTHESIA BREATHING CIRCUIT WITH FILTER, ZEFON PEDIATRIC ANESTHESIA BREATHING CIRCUIT WITH FILTER

FDA 510(k)

FDA Class 2 ·Anesthesiology

DEVMED REUSEABLE TROCAR SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology