Kit, Rna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·Aptima HPV 16 18/45 Genotype Assay

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Level VIII Controlled Environment Area (CEA), Level IX CEA Dry Room

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Avant, Entrant, Gallant, Neutrino NxT

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·NexGen LPS-Flex / LPS Mobile Bearing Knee System

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

FDA Pre-Market Approval

FDA Class 3 ·Arctic Front® Advance Cardiac Cryoablation Catheter

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·PRECISION SPINAL CORD STIMULATION(SCS) SYSTEM

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·Aptima HBV Quant Assay

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·MynxGrip and Mynx Ace Vascular Closure Device

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·Aptima HCV Quant Dx Assay

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PRIZM, PRIZM HE, PRIZM 2, VITALITY, VITALITY 2, VITALITY AVT, VITALITY DS, VITALITY EL, VITALITY HE

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Level VIII Controlled Environment Area (CEA), Level IX CEA Dry Room

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·RESTORE RECHARGEABLE,RESTORE PRIME,RESTORE,ADVANCED,PRIME ADVANCED,RESTORE ULTRA,ITREL 4,SYNERGY,SYNERGY VERSTIREL

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·CONTAK TR CARDIAC RESYNCHRONIZATION THERAPY SYSTEMS

Barrier, Absorbable, Adhesion

FDA Pre-Market Approval

FDA Class 3 ·Gynecare Interceed Absorbable Adhesion Barrier

Quickie Xtender

FDA UDI

SUNRISE MEDICAL (US) LLC·00016958056761·The Quickie® Xtender® electric assist wheelchai...

Dropper Urine Chemistry Control Level 2 Set 3x25mL

FDA UDI

QUANTIMETRIX CORPORATION·00896863002226·The Dropper Urine Chemistry Control is intended...

MR-RT

FDA UDI

Philips Oy·00884838098206·MR-RT is an add-on to the existing Ingenia 1.5T...

MR-RT

FDA UDI

Philips Oy·00884838094093·MR-RT is an add-on to the existing Ingenia 1.5T...

Dropper Urine Chemistry Control Level 1 Set 3x25mL

FDA UDI

QUANTIMETRIX CORPORATION·00896863002202·The Dropper Urine Chemistry Control is intended...

BE 117-W Disposable Tee Adapter

FDA UDI

INSTRUMENTATION INDUSTRIES, INCORPORATED·M996BE117W0·The BE 117-W Tee Adapter is intended for use in...