HD 1224658

Certificate

MDD Annex II (excluding section 4)·H4D·TÜV Rheinland LGA Products GmbH·2 Basic UDI-DIs

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·AMPLATZER PFO OCCLUDER

DORSAL FLEXION HOD 1" 4 (PHASE 1) 1" 4/PK

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Scott Specialties Inc·1 device

Automated Breast Ultrasound

FDA Pre-Market Approval

FDA Class 3 ·SOMO.V ABUS (AUTOMATED BREAST ULTRASOUND SYSTEM)

OverStitch Sx Endoscopic Suturing System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

OverStitch Endoscopic Suturing System and Accessories

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

OverStitch SX Endoscopic Suturing System (ESS)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

OverStitch NXT Endoscopic Suturing System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Geonic Nasal Aspirator, Geonic Nasal Cleaner

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

HTD Medical s.r.l.

Importer

🇮🇹 Italy·1 Manufacturer

WALKAIDE SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

Disposable Nitrile Examination Glove

FDA 510(k)

FDA Class 1 ·General Hospital

Stimulator, Carotid Sinus Nerve

FDA Pre-Market Approval

FDA Class 3 ·BAROSTIM NEO® System

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER M1000

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·FLUOROPERM (PAFLUFOCON A) RGP CONTACT LENS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·RIGID GAS PERMEABLE CONTACT LENSES

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·BOSTON(R) RXD(TM)(ITABISFLUOROFOCON A) BIFOCAL LEN

Electrosurgical, Radio Frequency, Refractive Correction

FDA Pre-Market Approval

FDA Class 3 ·VIEWPOINT CK SYSTEM

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·O-PERM F60 RGP CONTACT LENS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·HYDROPERM (TM) RIGID GAS PERMEABLE CONTACT LENS