OPTRELL™ Mapping Catheter with TRUEref™ Technology

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000

FDA 510(k)

FDA Class 2 ·Cardiovascular

CONSTELLATION MULTIPLE ELECTRODE PACING AND RECORDING SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

FLOWER HIGH-DENSITY MAPPING CATHETER, 4-4-4 MM ELECTRODE SPACING), (2-6-2 MM ELECTRODE SPACING)

FDA 510(k)

FDA Class 2 ·Cardiovascular

FIRMAP CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled

FDA 510(k)

FDA Class 2 ·Cardiovascular

CLASSICSTAR NV SE AND NOVASTAR NV SE AND AAV FULL FACE MASKS

FDA 510(k)

FDA Class 2 ·Anesthesiology

Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full Face Non-Vented Mask, Veraseal 3 Full Face AAV Non-Vented

FDA 510(k)

FDA Class 2 ·Anesthesiology

Mojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face AAV Non-Vented Mask; Veraseal 3 Full Face Non-Vented Mask; Veraseal 3 Full Face AAV Non-Vented Mask

FDA 510(k)

FDA Class 2 ·Anesthesiology

CALMATRIX CALCIUM SULFATE BONE GRAFT BINDER

FDA 510(k)

FDA Class 2 ·Dental

LRM PRODUCES GUIDEWIRES ON AN OEM BASIS FOR MANUFACTURERS,KIT ASSEMBLERS, AND DISTRIBUTORS.

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

H500 Multi-Sensing Oximetry System

FDA 510(k)

FDA Class 2 ·Cardiovascular

LORI HEARING AID SIMULATOR

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

NEUROMETRIX ADVANCE

FDA 510(k)

FDA Class 2 ·Neurology

BOND-IT DUAL CURE ACTIVATOR

FDA 510(k)

FDA Class 2 ·Dental

Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor

FDA 510(k)

FDA Class 2 ·Cardiovascular

LAKE REGION MANUFACTURING GUIDEWIRES

FDA 510(k)

FDA Class 2 ·Cardiovascular

HYDROPHILIC COATED GUIDEWIRE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Model X-100C CO-Met™ Oximetry System

FDA 510(k)

FDA Class 2 ·Cardiovascular

NC-STAT

FDA 510(k)

FDA Class 2 ·Neurology