System, Photopheresis, Extracorporeal

FDA Pre-Market Approval

FDA Class 3 ·UVAR XTS PHOTOPHERESIS SYSTEM

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·MODEL 3000 SERIES IMPLANTABLE INFUSION PUMPS

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·Y Adaptor/Extender Kit; HV Splitter/Adaptor Kit; Sprint Quattro Lead.

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ARCHITECT Anti-HCV Reagent Kit, Alinity i Anti-HCV Reagent Kit

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT Total PSA Reagent Kit, Alinity i Total PSA Reagent Kit

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT Free PSA Reagent Kit, Alinity i Free PSA Reagent Kit

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·Abbott RealTime IDH2 Amplification Reagent Kit, Abbott RealTime IDH2 Control Kit

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·artus CMV RGQ MDx Kit and artus CMV QS_RGQ MDx Kit

Prosthesis, Spinous Process Spacer/Plate

FDA Pre-Market Approval

FDA Class 3 ·Superion™ Indirect Decompression System (IDS) Kit, Vertiflex Instrument Platform (VIP) Kit

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC ACTIVA DEEP BRAIN STIMULATION (DBS) SYSTEMS MODELS 3387S, 3389S DBS LEADS

System, Photopheresis, Extracorporeal

FDA Pre-Market Approval

FDA Class 3 ·THERAKOS CELLEX PHOTOPHERESIS SYSTEM PROCEDURAL KIT

Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees

FDA Pre-Market Approval

FDA Class 3 ·OPRA™ System

KIT, FIRST AID, GENERAL PURPOSE, RIGID CASE

FDA 510(k)

FDA Not Classified ·Unknown

ABBOTT STREP A CONTROLS

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

CERTIBURN BURN/TRAUMA FACE DRESSING /TOWEL DRESSING

FDA 510(k)

FDA Not Classified ·Unknown

BONE-TEMNO/STERNUM-TEMNO

FDA 510(k)

FDA Class 2 ·Unknown

CEP 8 SPECTRUMORANGE DNA PROBE KIT

FDA 510(k)

FDA Class 2 ·Immunology

FLEXIBLE CHOLEDOCHOSCOPE/NEPHROSCOPE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CONCEIVEX CONCEPTION KIT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

FIRST AID/TRUMA KIT

FDA 510(k)

FDA Not Classified ·Unknown