Mitral Valve Repair Devices

FDA Pre-Market Approval

FDA Class 3 ·MitraClip™ G4 Clip Delivery System

Quantib Brain

FDA 510(k)

FDA Class 2 ·Radiology

Quantib ND

FDA 510(k)

FDA Class 2 ·Radiology

Quantib AI Node

FDA 510(k)

FDA Class 2 ·Radiology

Quantib Prostate

FDA 510(k)

FDA Class 2 ·Radiology

Quantib Prostate

FDA 510(k)

FDA Class 2 ·Radiology

Quantib Prostate

FDA 510(k)

FDA Class 2 ·Radiology

Sterile Water USP and Sterile 0.9% Normal Saline USP

FDA 510(k)

FDA Unclassified ·Unknown

STERILE SURGICAL LATEX GLOVES

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

SAS LATEX EXAMINATION GLOVES

FDA 510(k)

FDA Class 1 ·General Hospital

NITRILE EXAMINATION GLOVES- PRE-POWDERED, SMALL, MEDIUM, AND LARGE

FDA 510(k)

FDA Class 1 ·General Hospital

Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance Device - DIMEI PEEK, Intersomatic Transforaminal - TLIF PEEK

FDA 510(k)

FDA Class 2 ·Orthopedic

DPZ Pedicular Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

Laboratorios Biogalenic Sterile Water for Inhalation, USP

FDA 510(k)

FDA Class 2 ·Anesthesiology

Anterior Cervical Plate System

FDA 510(k)

FDA Class 2 ·Orthopedic

GROUP AKM-NI LTD

Authorized representative

1 Manufacturer·5 Devices

SKIN GUARD, POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE

FDA 510(k)

FDA Class 1 ·General Hospital

HYGENIC® GuttaFlow®2

FDA UDI

Coltène/Whaledent GmbH + Co. KG·E165600137100·The HYGENIC® GuttaFlow®2 Introkit contains 1 x ...

GuttaSil

FDA UDI

Meta Biomed Co., Ltd.·08806387893875·GuttaSil, a product in the form of a paste whic...

ROEKO GuttaFlow®2

FDA UDI

Coltène/Whaledent GmbH + Co. KG·E165600137040·