Mitral Valve Repair Devices

FDA Pre-Market Approval

FDA Class 3 ·MitraClip System (NTR and XTR)

Mitral Valve Repair Devices

FDA Pre-Market Approval

FDA Class 3 ·MitraClip NTR/XTR Delivery System

Mitral Valve Repair Devices

FDA Pre-Market Approval

FDA Class 3 ·MitraClip System (NTR and XTR)

ETG PLUS QC LEVEL 3 V2

FDA UDI

UTAK LABORATORIES, INC.·B800ETGQC3V2UFUCSF0·ETG PLUS QC LEVEL 3 V2

ETG PLUS QC LEVEL 2 V2

FDA UDI

UTAK LABORATORIES, INC.·B800ETGQC2V2UFUCSF0·ETG PLUS QC LEVEL 2 V2

ETG PLUS QC LEVEL 1 V2

FDA UDI

UTAK LABORATORIES, INC.·B800ETGQC1V2UFUCSF0·ETG PLUS QC LEVEL 1 V2

Disposable Cytology Brush BC-202D/203D Series

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MAESTRO PACEMAKER TEST MAGNET

FDA 510(k)

FDA Class 1 ·Cardiovascular

Single Use Cytology Brush BC-205D

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MAGNO ALARM

FDA 510(k)

FDA Class 1 ·Cardiovascular

IMPLANTABLE ENDOCARDIAL PACING LEADS

FDA 510(k)

FDA Class 1 ·Cardiovascular

SUPERDIMENSION TRIPLE-NEEDLE CYTOLOGY BRUSH

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

CYTOLOGY BRUSH

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MICROBIOLOGY SPECIMEN BRUSH

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Pulmonary Cytology Brush

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

TEST MAGNET

FDA 510(k)

FDA Class 1 ·Cardiovascular

MODEL 220 PATIENT MAGNET

FDA 510(k)

FDA Class 1 ·Cardiovascular

FITTING/DIALYZER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NIKKISO PARALLEL FLOW DIALYZERS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Ethyl Glucuronide (ETG) Test Dip Card 500 (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market