ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Orbital PAD

FDA 510(k)

FDA Class 2 ·Cardiovascular

REVEAL XT; INSERTABLE CARDIAC MONITOR (MODEL 9529), PATIENT ASSISTANT (MODEL 9539)

FDA 510(k)

FDA Class 2 ·Cardiovascular

SRT-100+

FDA 510(k)

FDA Class 2 ·Radiology

ControlRad Trace Model 9

FDA 510(k)

FDA Class 2 ·Radiology

WIRION Embolic Protection System

FDA 510(k)

FDA Class 2 ·Cardiovascular

CONGRUENT BONE PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

SENSUS HEALTHCARE SUPERFICIAL RADIOTHERAPY SYSTEM SRT-100

FDA 510(k)

FDA Class 2 ·Radiology

ViperCath XC Peripheral Exchange Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

MateLaser Medical Laser Therapy Systems (ML-HIL-30, ML-HIL-60)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ACUTE BONE SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

Diacare 7000

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SCHROEDER ORAL/NASAL DIRECTIONAL STYLETTE

FDA 510(k)

FDA Class 1 ·Anesthesiology

DE-BOND 200

FDA 510(k)

FDA Class 1 ·Dental

Adravision Perio

FDA 510(k)

FDA Class 2 ·Radiology

Diamondback 360 Peripheral Orbital Atherectomy System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System, Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACUMED SMALL BONE LOCKING ROD SYSTEM II

FDA 510(k)

FDA Class 2 ·Orthopedic

FRAG-LOC SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ViperCross Support Catheters

FDA 510(k)

FDA Class 2 ·Cardiovascular

DripAssist

FDA 510(k)

FDA Class 2 ·General Hospital