LNI MGV MEDICAL GAS MIXER

FDA 510(k)

FDA Class 2 ·Anesthesiology

PEM 2400 PET SCANNER

FDA 510(k)

FDA Class 2 ·Radiology

SPI ONETIME DENTAL IMPLANT

FDA 510(k)

FDA Class 2 ·Dental

QUANTUM VERSATILITY (QVS) DENTAL IMPLANT SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

UNIVERSAL DENTAL COPING (UDC)

FDA 510(k)

FDA Class 2 ·Dental

MTA-FILLAPEX

FDA 510(k)

FDA Class 2 ·Dental

MEDIPART FACE MASK MP-XM-I

FDA 510(k)

FDA Class 2 ·Radiology

Cybird LED Curing Light

FDA 510(k)

FDA Class 2 ·Dental

D1 LED CURING LIGHT, SPEC 3, DENTRONIX LED 3000

FDA 510(k)

FDA Class 2 ·Dental

Cybird LED Curing Light

FDA 510(k)

FDA Class 2 ·Dental

DENJECTOR

FDA 510(k)

FDA Class 2 ·Dental

CYBIRD LED CURING LIGHT

FDA 510(k)

FDA Class 2 ·Dental

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·MENICON SF-P (TM)

CR MAMMOGRAPHY SYSTEM WITH DX-M DIGITIZER

FDA 510(k)

FDA Class 2 ·Radiology

Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000), Auryon Atherectomy Catheter 0.9 mm XL, Hydrophilic Coating (EXM-4011-H000), Auryon Atherectomy Catheter 1.5 mm XL (EXM -4010-0000), Auryon Atherectomy Catheter 0.9 mm XL (EXM-4011-0000)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Tester, Pacemaker Electrode Function

FDA Pre-Market Approval

FDA Class 2 ·PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM

MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (38 CM), MODEL 3555-38; MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (60 CM),

FDA 510(k)

FDA Class 2 ·Neurology

MEDTRONIC MODEL 7495LZ LOW IMPEDANCE EXTENSION

FDA 510(k)

FDA Class 2 ·Neurology

FOCUS-PV BALLOON DILATATION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

SOVEREIGN HIGH VACUUM PACK, SOVEREIGN COMPACT HIGH VACUUM PACK

FDA 510(k)

FDA Class 2 ·Ophthalmic