NovoGen Wound Matrix

FDA 510(k)

FDA Unclassified ·Unknown

Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D)

FDA 510(k)

FDA Class 2 ·Ophthalmic

WRIST FUSION PLATE

FDA 510(k)

FDA Class 2 ·Orthopedic

Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy system

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACUMED CONGRUENT BONE PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

BodyGuardian Remote Monitoring System

FDA 510(k)

FDA Class 2 ·Cardiovascular

CLEAR (TM) LICE EGG REMOVER SYSTEM

FDA 510(k)

FDA Class 1 ·General Hospital

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