Temporary Non-Roller Type Right Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella RP, Impella RP with Smart Assist, Impella $.0/LD

Temporary Non-Roller Type Right Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella RP System

Computer-Assisted Personalized Sedation System

FDA Pre-Market Approval

FDA Class 3 ·SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval

FDA Class 3 ·APILGRAF(GRAFTSKIN)

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon, IN.PACT 018 Paclitaxel-Coated Per

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Carpentier-Edwards PERIMOUNT/PERIMOUNT RSR/Magna Pericardial Aortic Bioprosthesis; Carpentir-Edwards PERIMOUNT Theon/PER

Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary

FDA Pre-Market Approval

FDA Class 3 ·HORIZON(TM) YAG LASER MODEL 2000

Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary

FDA Pre-Market Approval

FDA Class 3 ·HORIZON(TM) YAG LASER MODEL 2000

Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary

FDA Pre-Market Approval

FDA Class 3 ·HORIZON(TM) YAG LASER MODEL 2000

Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary

FDA Pre-Market Approval

FDA Class 3 ·HORIZON(TM) YAG LASER MODEL 2000

Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary

FDA Pre-Market Approval

FDA Class 3 ·HORIZON(TM) YAG LASER MODEL 2000

Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary

FDA Pre-Market Approval

FDA Class 3 ·HORIZON(TM) YAG LASER MODEL 2000

Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary

FDA Pre-Market Approval

FDA Class 3 ·HORIZON(TM) YAG LASER MODEL 2000

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Carpentier-Edwards PERIMOUNT Magna Pericardial Aortic Bioprosthesis 3000, with ThermaFix tissue process 3000TFX,Ease Per

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·BIOMERIEUX THXID BRAF ASSAY KIT

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·Alinity m HBV

Cancer-Related Germline Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·BRACANALYSIS CDX

Cancer-Related Germline Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·BRACANALYSIS CDX

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·Abbott RealTime IDH1

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·cobas® EZH2 Mutation Test