ThermoSuit System

FDA UDI

LIFE RECOVERY SYSTEMS HD LLC·00851936007119·

Thermosuit System

FDA UDI

LIFE RECOVERY SYSTEMS HD LLC·00851936007010·

ThermoSuit System

FDA UDI

LIFE RECOVERY SYSTEMS HD LLC·00851936007072·

ThermoSuit System

FDA UDI

LIFE RECOVERY SYSTEMS HD LLC·00851936007003·

ThermoSuit System

FDA UDI

LIFE RECOVERY SYSTEMS HD LLC·00851936007041·

SUN SIGHT SUNGLASSES/SUN SIGHT READING GLASSES

FDA 510(k)

FDA Class 1 ·Ophthalmic

Neoss Ti Reinforced Membrane

FDA 510(k)

FDA Class 2 ·Dental

Neoss TiBase, Neoss CoCr Abutments (Mono and Multi)

FDA 510(k)

FDA Class 2 ·Dental

MOONCUP

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ENDOFLIP

FDA 510(k)

FDA Class 2 ·Orthopedic

Neoss Individual Prosthetics

FDA 510(k)

FDA Class 2 ·Dental

Membrane Screws and Membrane Tacks

FDA 510(k)

FDA Class 2 ·Dental

NEOSS ACCESS ABUTMENTS

FDA 510(k)

FDA Class 2 ·Dental

Lens, Contact (Polymethylmethacrylate)

FDA Pre-Market Approval

FDA Unclassified ·AQUAFLEX(R) HGP(TM) RIGID GAS PERMEABLE LENSES

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·BLAZER II, BLAZER II HTD TEMPERATURE ABLATION CATHETERS

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·Blazer II, Blazer II HTD, Blazer II XP, Blazer Prime HTD, Blazer Prime XP, IntellaTip MiFi XP, IntellaNav MiFi XP, Intel

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·BLAZER II AND BLAZER PRIME HTD CARDIAC ABLATION CATHETERS

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·Gel-One

Oragene Dx

FDA UDI

DNA Genotek Inc·00627595000019·DNA Specimen Collection, Saliva

Atos Medical

FDA UDI

ATOS MEDICAL INC.·00817126020962·2010-071 Laryngectomy Pulmonary Kit with Libert...