Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System Accessories

FDA 510(k)

FDA Class 2 ·Neurology

ULTRATONE 8+ & 20

FDA 510(k)

FDA Class 2 ·Physical Medicine

AIR MASSAGE SYSTEM

FDA 510(k)

FDA Class 2 ·Physical Medicine

CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box

FDA 510(k)

FDA Class 2 ·Cardiovascular

Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box)

FDA 510(k)

FDA Class 2 ·Neurology

LOVESAFE PLAIN CONDOM 1/4 DZ. CONDOMS/BOX PC-30

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

OX-GEN FLEXIBLE O2 GENERATION SYSTEM, MODEL 6-OX-03

FDA 510(k)

FDA Class 2 ·Anesthesiology

Mesh, Surgical, Polymeric

FDA Pre-Market Approval

FDA Class 2 ·FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT

POLAR PAD (STERILE)

FDA 510(k)

FDA Class 2 ·Physical Medicine

JUNIPER CLN1 DERMAL COOLING DEVICE

FDA 510(k)

FDA Class 2 ·Physical Medicine

POLAR CARE 300

FDA 510(k)

FDA Class 2 ·Physical Medicine

DUAL-TEMP(TM) COOLING/WARMING UNIT

FDA 510(k)

FDA Class 2 ·Physical Medicine

MODEL 1100 COLD THERAPY DEVICE

FDA 510(k)

FDA Class 2 ·Physical Medicine

EBICE

FDA 510(k)

FDA Class 2 ·Physical Medicine

HOT/ICE DUAL FUNCTION EQUIPMENT

FDA 510(k)

FDA Class 2 ·Physical Medicine

EBICE

FDA 510(k)

FDA Class 2 ·Physical Medicine

CONTRAST 7000 THERAPY SYSTEM

FDA 510(k)

FDA Class 2 ·Physical Medicine

ORTHO TECH CRYOLOGIC SYSTEM

FDA 510(k)

FDA Class 2 ·Physical Medicine

CRYTRON SYSTEM

FDA 510(k)

FDA Class 2 ·Physical Medicine

INCARE HOT/ICE LITE MACHINE

FDA 510(k)

FDA Class 2 ·Physical Medicine