SPACEMISER 8-10 FILM RECORDER

FDA 510(k)

FDA Class 2 ·Radiology

16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247)

FDA 510(k)

FDA Class 2 ·Radiology

NEUROSTAR TMS THERAPY SYSTEM, MODEL 1.1

FDA 510(k)

FDA Class 2 ·Neurology

4CIS VANE SPINE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Sourcerer

FDA 510(k)

FDA Class 2 ·Neurology

Endoskeleton(R) TAS Interbody Fusion Device / Endoskeleton(R) TAS Hyperlordotic Interbody Fusion Device

FDA 510(k)

FDA Class 2 ·Orthopedic

MC2 Portable X-ray System

FDA 510(k)

FDA Class 2 ·Radiology

Dexter L6 System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Dexter L6 System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MEDRAD SPECTRIS MR INJECTOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

Cloud Smart Thermometer

FDA 510(k)

FDA Class 2 ·General Hospital

SURGICAL GOWN, POLYULTRA(TM) FABRIC SYSTEM*

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MODIFICATION TO: SPIRIT

FDA 510(k)

FDA Class 2 ·Anesthesiology

MEDRAD QWIK-FIX MRI DISPOSABLE KIT

FDA 510(k)

FDA Class 2 ·Radiology

PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE

FDA 510(k)

FDA Class 2 ·Cardiovascular

LSH (MANGOFILCON A) SPHERE SOFT (HYDROPHILIC) CONTACT LENS, LSH (MANGOFILCON A) MULTIFOCAL SOFT (HYDROPHILIC) CONTACT LE

FDA 510(k)

FDA Class 2 ·Ophthalmic

SAFE-1(TM) SYRINGE

FDA 510(k)

FDA Class 2 ·General Hospital

L-SER KO LAMP

FDA 510(k)

FDA Class 2 ·Physical Medicine

Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop® Fentanyl/Norfentanyl Urine Rapid Test Panel

FDA 510(k)

FDA Class 2 ·Clinical Toxicology