KidneyIntelX.dkd

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Prognostic Test For Assessment Of Chronic Kidney Disease Progression

FDA classification

FDA Class 2 ·Prognostic Test For Assessment Of Chronic Kidney Disease Progression

Cold Sore Device (QPZ-03)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

QWH-300 WRIST ARRAY COIL

FDA 510(k)

FDA Class 2 ·Radiology

QWH-149 WRIST ARRAY COIL

FDA 510(k)

FDA Class 2 ·Radiology

QWH-085 WRIST ARRAY COIL

FDA 510(k)

FDA Class 2 ·Radiology

QWH-250-PAN WRIST ARRAY COIL

FDA 510(k)

FDA Class 2 ·Radiology

Cold Sore Device (Model: QPZ-01)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MODIFICATION TO: QWH-420 WRIST ARRAY COIL

FDA 510(k)

FDA Class 2 ·Radiology

MODEL #QWH-63, QUADRATURE WRIST AND HAND COIL

FDA 510(k)

FDA Class 2 ·Radiology

ZMR HIP SYSTEM KWZ-PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER

FDA 510(k)

FDA Class 2 ·Orthopedic

Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer

FDA Pre-Market Approval

FDA Class 2 ·S-ROM POLY-DIAL CONSTRAINED LINER

Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer

FDA Pre-Market Approval

FDA Class 2 ·S-ROM POLY-DIAL CONSTRAINED ACETABULAR LINER

Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer

FDA Pre-Market Approval

FDA Class 2 ·OSTEONICS CONSTRAINED ACETABULAR INSERT

Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer

FDA Pre-Market Approval

FDA Class 2 ·S-ROM POLY-DAIL CONSTRAINED LINER

Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer

FDA Pre-Market Approval

FDA Class 2 ·S-ROM POLY-DIAL CONSTRAINED LINER

MAGGI SERIES ULTRA. NEEDLE, BIOPSY/CATHETER GUIDES

FDA 510(k)

FDA Class 2 ·Cardiovascular

BIOPSY FORCEPS

FDA 510(k)

FDA Class 2 ·Cardiovascular

T-REX BIOPSY FORCEPS

FDA 510(k)

FDA Class 2 ·Cardiovascular

ENDOMYOCARDIAL BIOPSY DEVICE

FDA 510(k)

FDA Class 2 ·Cardiovascular