Calibrator For Alpha-Fetoprotein In Mid-Pregnancy Maternal Serum

FDA Pre-Market Approval

FDA Class 3 ·AFP MID-PREGNANCY REFERENCE PREPARATION

Sensor, Electro-Optical (For Cervical Cancer)

FDA Pre-Market Approval

FDA Class 3 ·LUMA CERVICAL IMAGING SYSTEM

Colon Computed Tomography System, Computer Aided Detection

FDA classification

FDA Class 2 ·Colon Computed Tomography System, Computer Aided Detection

170771754

Certificate

MDD Annex II (excluding section 4)·BSC Medical Devices GmbH·DQS Medizinprodukte GmbH·11 Basic UDI-DIs

170770754

Certificate

MDD Annex II (excluding section 4)·BSC Medical Devices GmbH·DQS Medizinprodukte GmbH·1 Basic UDI-DI

Zip 8i Surgical Skin Closure Device

FDA UDI

ZIPLINE MEDICAL, INC.·00853114007010·Zip 8i Surgical Skin Closure Device, BSC

Zip 16 Surgical Skin Closure Device

FDA UDI

ZIPLINE MEDICAL, INC.·00853114007027·Zip 16 Surgical Skin Closure Device, BSC

ASC BV

Authorized representative

🇳🇱 Netherlands·1 Manufacturer

AGFA CR50.0

FDA 510(k)

FDA Class 2 ·Radiology

PRESSON ELECTRODE

FDA 510(k)

FDA Class 2 ·Neurology

PATIENT EXAMINATION GLOVE

FDA 510(k)

FDA Class 1 ·General Hospital

0.9.% SODIUM CHLORIDE INHALATION SOLUTION, USP

FDA 510(k)

FDA Class 2 ·Anesthesiology

L11, L12 LINEAR AND C11, C12 CONVEX ARRAY TRANSDUC

FDA 510(k)

FDA Class 2 ·Radiology

UNILYTE A

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

POWDER-FREE NITRILE EXAMINATION GLOVES

FDA 510(k)

FDA Class 1 ·General Hospital

GLUCOMMANDER PLUS

FDA 510(k)

FDA Class 2 ·Anesthesiology

CLOTHINGUARD

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

Ti3Z Cervical Interbody System

FDA 510(k)

FDA Class 2 ·Orthopedic

VINYL EXAM GLOVES (MFG. UNIVERSAL GLOVE CORP.)

FDA 510(k)

FDA Class 1 ·General Hospital

FREEDOMAIRE III SURGICAL HELMET SYSTEM MODEL 10322STK

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery