Immunohistochemistry Assay, Antibody, Ki-67

FDA Pre-Market Approval

FDA Class 3 ·Ki-67 IHC MIB-1 pharmDx (Dako Omnis)

Immunohistochemistry Assay, Antibody, Ki-67

FDA Pre-Market Approval

FDA Class 3 ·Ki-67 IHC MIB-1 pharmDx (Dako Omnis)

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MY CARELINK PATIENT MONITOR MODEL 24950

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC MODEL 25000 MY CARELINK SMART READER

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MY CARE-LINK SMART MONITOR PATIENT READER

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CareLink Express Monitor, Monitor CardioSight Reader, My CareLink Patient Monitor.

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval

FDA Class 3 ·CollaPlug Absorbable Collagen Wound Dressing For Dental Surgery

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·ENTERYX PROCEDURE KIT

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·ENTERYX PROCEDURE KIT, MODEL M000572600

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·ENTERYX PROCEDURE KIT

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·ENTERYX PROCEDURE KIT

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·ENTERYX PROCEDURE KIT

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·MODEL 5071 LEAD

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne CDx (F1CDx)

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval

FDA Class 3 ·DERMAGRAFT-TC(TM)

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·COMBI 40+ SYSTEM WITH C40+ OR PULSARCI100 COCHLEAR IMPLANTS

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval

FDA Class 3 ·TRANSCYTE

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·Implantable System for Remodulin (ISR)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·BIOCURVE SOFT EW (METHAFILCON A) HYDROPHILIC CONTACT LENSES