VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM

FDA 510(k)

FDA Class 2 ·Cardiovascular

Cranial Reducing Tubes

FDA 510(k)

FDA Class 2 ·Neurology

COBE CATHETER W/GUIDEWIRE ASSEMBLY KIT

FDA 510(k)

FDA Class 2 ·Cardiovascular

Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SPECTRUM SPINE LAMINOPLASTY PLATING SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

MAMMOSCAN

FDA 510(k)

FDA Class 2 ·Radiology

SAVIEW 55F (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR

FDA 510(k)

FDA Class 2 ·Ophthalmic

ANALGESIA GAS MACHINE, MODEL DIGITAL ULTRA

FDA 510(k)

FDA Class 2 ·Anesthesiology

DISPOSABLE ELECTROSURGERY BALL ELECTRODE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NORTHERNLIGHTS ORTHODONTIC BONDING SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

FLEXLENS MULTIFOCAL SOFT CONTACT LENS, (HIOXIFILCON A) AND (HIOXIFILCON B) FOR DAILY WEAR

FDA 510(k)

FDA Class 2 ·Ophthalmic

OPTIMUM GP (ROFLUFOCON A,B,C,D&E) DAILY WEAR CONTACT LENS.

FDA 510(k)

FDA Class 2 ·Ophthalmic

BIOROOT RCS

FDA 510(k)

FDA Class 2 ·Dental

RADIOCAMERAS PATIENT POSITIONING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

STEATHSTATION TREATMENT GUIDANCE PLATFORM

FDA 510(k)

FDA Class 2 ·Neurology

AIRPREP SYSTEM - MODEL 9001

FDA 510(k)

FDA Class 2 ·Dental

INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor)

FDA 510(k)

FDA Class 2 ·Cardiovascular

MULTI-CHANNEL ISOLATION AMPLIFIER (MCIA)

FDA 510(k)

FDA Class 2 ·Neurology

STORZ IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

CARDIOSPECT D90/CARDIO CAM

FDA 510(k)

FDA Class 2 ·Radiology