Osprey Medical Inc.

Manufacturer

🇺🇸 United States·7 Importers

Cardiac Dimensions, Inc.

Manufacturer

🇺🇸 United States·1 Basic UDI-DI·78 Devices·DEKRA Certification B.V.

Inspire Medical Systems Inc

Manufacturer

🇺🇸 United States·1 Importer

ZAP Surgical Systems, Inc.

Manufacturer

🇺🇸 United States·2 Importers

Allurion Technologies Inc.

Manufacturer

🇺🇸 United States·8 Basic UDI-DIs·8 Devices·TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, and TÜV SÜD Product Service GmbH

Venclose, Inc.

Manufacturer

🇺🇸 United States·9 Basic UDI-DIs·9 Devices·3 Importers·DNV Product Assurance AS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·AFFINITY SR MODELS 5130 (LS,RS,L,R)PULSE GENERATORS AFFINITY DR MODELS 5330 (LS, RS,L,R)PULSE GENERATORS

PATIENT EXAMINATION GLOVES (LATEX)

FDA 510(k)

FDA Class 1 ·General Hospital

LATEX EXAMINATION GLOVES

FDA 510(k)

FDA Class 1 ·General Hospital

RUBBER, DENTAL DAM (NON-STERILE)

FDA 510(k)

FDA Class 1 ·Dental

PATIENT EXAMINATION GLOVES (LATEX)

FDA 510(k)

FDA Class 1 ·General Hospital

OC-66

FDA registration

TOPCON EUROPE MEDICAL BV·1 product·🇳🇱 Netherlands

FAVO S-TLIF-Cage

FDA registration

BAAT MEDICAL PRODUCTS B.V.·2 products·🇳🇱 Netherlands

IC-1

FDA registration

TOPCON EUROPE MEDICAL BV·1 product·🇳🇱 Netherlands

IS-600N

FDA registration

TOPCON EUROPE MEDICAL BV·1 product·🇳🇱 Netherlands

Kleiner KG2 System

FDA registration

BAAT MEDICAL PRODUCTS B.V.·1 product·🇳🇱 Netherlands

Oyster ACIF Trial

FDA registration

BAAT MEDICAL PRODUCTS B.V.·1 product·🇳🇱 Netherlands

Oyster ACIF Cage

FDA registration

BAAT MEDICAL PRODUCTS B.V.·1 product·🇳🇱 Netherlands

Sinefix

FDA registration

BAAT MEDICAL PRODUCTS B.V.·1 product·🇳🇱 Netherlands

Fortilink Cages with TiPlus technology

FDA registration

BAAT MEDICAL PRODUCTS B.V.·4 products·🇳🇱 Netherlands