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

FDA 510(k)

FDA Class 2 ·Cardiovascular

ViperCath XC Peripheral Exchange Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

WIRION

FDA 510(k)

FDA Class 2 ·Cardiovascular

WARSAW ORTHOPEDIC BONE PLATE

FDA 510(k)

FDA Class 2 ·Orthopedic

mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial Prosthesis Kit

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED NC MAXXUM PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER

Luna G3 BPAP System

FDA 510(k)

FDA Class 2 ·Anesthesiology

Aer X

FDA 510(k)

FDA Class 2 ·Anesthesiology

Luna® G3 BPAP 25A

FDA 510(k)

FDA Class 2 ·Anesthesiology

Curos Jet Disinfecting Cap

FDA 510(k)

FDA Class 2 ·General Hospital

Ambient KVac Wand with Integrated Finger Switches (Ambient KVac IFS), KVac Integrated Cable Wand (KVac ICW)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TRACKER 2/TRACKER 3 HOLTER RECORDER

FDA 510(k)

FDA Class 2 ·Cardiovascular

EVENTSTATION ECG TRANS-TELEPHONIC RECEIVING SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

SODIUM CHLORIDE SOLUTION BLOOD CELL

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MICROMAT W/VARIOUS MODELS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery