Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

FDA Pre-Market Approval

FDA Class 3 ·BIRMINGHAM HIP RESURFACING (BHR) SYSTEM

CLX ACETABULAR CUP (WAGNER) FOR CEMENTLESS FIXAT.

FDA 510(k)

FDA Class 3 ·Orthopedic

DEPUY ASR XL MODULAR ACETABULAR CUP SYSTEM

FDA 510(k)

FDA Class 3 ·Orthopedic

KM-4(TM) METAL-BACKED ACETABULAR CUP

FDA 510(k)

FDA Class 3 ·Orthopedic

PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS

FDA 510(k)

FDA Class 3 ·Orthopedic

SCHUSTER ACETABULAR CUP FOR CEMENT/CEMENTLESS FIX.

FDA 510(k)

FDA Class 3 ·Orthopedic

DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS

FDA 510(k)

FDA Class 3 ·Orthopedic

DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS

FDA 510(k)

FDA Class 3 ·Orthopedic

DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINER

FDA 510(k)

FDA Class 3 ·Orthopedic

DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS

FDA 510(k)

FDA Class 3 ·Orthopedic

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval

FDA Class 3 ·Ceramax® Ceramic Total Hip System

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ANGIOJET RHEOLYTIC THROMBECTOMY CATHETER SYSTEM

S-ROM(R) ZTT(TM) ACETABULAR CUP-APICAL HOLE PLUG

FDA 510(k)

FDA Class 3 ·Orthopedic

Dorsal Root Ganglion Stimulator For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Proclaim DRG Systems

System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA Pre-Market Approval

FDA Class 3 ·COLOGUARD

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

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne Liquid CDx (F1 Liquid CDx)

System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA Pre-Market Approval

FDA Class 3 ·Cologuard®

System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA Pre-Market Approval

FDA Class 3 ·Shield

Dorsal Root Ganglion Stimulator For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Proclaim DRG IPG (Model 3664), DRG 50cm leads (models MN10450-50, MN10450-50A), port plug (Model 7108), lead anchor

Dorsal Root Ganglion Stimulator For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·St. Jude Medical Clinician Programmer Application, St. Jude Medical Patient Controller Application, Proclaim DRG Implant