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

FDA Pre-Market Approval

FDA Class 3 ·ACCESS HYBRITECH FREE PSA REAGENT/CALIBRATOR KIT

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MODEL 6866 AICD SPLICE TOOL KIT,6862,63,65,34

System, Photopheresis, Extracorporeal

FDA Pre-Market Approval

FDA Class 3 ·THERAKOS UVAR XTS Photopheresis System Procedural Kit

Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit

FDA Pre-Market Approval

FDA Class 3 ·AvertD and AvertD Buccal Sample Collection Kit

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·HV Splitter/Adaptor kit, Sprint Quattro Lead

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·SURGIFLO® Hemostatic Matrix Kit with Thrombin

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·LEAD ANCHORING SLEEVE KIT; SELECT SECURE LEAD

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·Alinity i Anti-HBc IgM Reagent Kit

Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

FDA Pre-Market Approval

FDA Class 3 ·VYSIS ALK BREAK APART FISH PROBE KIT

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·HV splitter/adaptor kit; Sprint Quattro Lead

System, Test, Her-2/Neu, Nucleic Acid Or Serum

FDA Pre-Market Approval

FDA Class 3 ·Path Vysion HER-2 DNA Probe Kit

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ECG CABLE/CAPSURE VDD LEADS DRUG COMBINATION/SERVICE KIT PACEMAKER REPAIR KIT/PRODIGY IPG/BRILLIANT S+ VDD VITATRON LEAD

Test, Urea Adult And Pediatric (Breath),

FDA Pre-Market Approval

FDA Class 3 ·BREATH TEK UBT FOR H.PYLORI KIT (BREATH TEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·HV Splitter/Adaptor Kit, IS-1 Connector Port Pin Plug Kit, Transvene CS/SVC Lead and Sprint Quattro Lead

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·Alinity i HBsAg Qualitative II Reagent Kit (2x100 Tests), Alinity i HBsAg Qualitative II Reagent Kit (2x600 Tests), Alin

Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

FDA Pre-Market Approval

FDA Class 3 ·VYSIS ALK BREAK APART FISH PROBE KIT, VYSIS PARAFFIN PRETREATMENT IV & POST HYBRIDIZATION WASH BUFFER KIT PROBECHEK ALK

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·Y Adapter/Extender Kit, IS-1 Connector Port Pin Plug Kit, Lead Adapter, Sprint Quattro Lead, Subcutaneous Lead, Transven

System, Photopheresis, Extracorporeal

FDA Pre-Market Approval

FDA Class 3 ·THERAKOS UVAR XTS INSTRUMENT, THERAKOS UVAR XTS PROCEDURAL KIT (125 ML), THERAKOS UVAR XTS PORCEDURAL KIT (225 ML), THEA

Dorsal Root Ganglion Stimulator For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·SlimTip™ Dorsal Root Ganglion (DRG) Trial Lead Kit, 50cm, SlimTip™ Dorsal Root Ganglion (DRG) Trial Lead Kit, 90cm, Slim

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·HV splitter/adaptor kit, IS-1 Connector Port Pin Plug Kit, Lead Adaptor, Sprint Quattro Lead, Subcutaneous Lead, Transve