Phönix-PACS GmbH

Manufacturer

🇩🇪 Germany·2 Basic UDI-DIs·4 Devices

Omni-Pac GmbH Verpackungsmittel

Manufacturer

🇩🇪 Germany

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·samaritan® PAD 350P (SAM 350P), samaritan® PAD 360P (SAM 360P), samaritan® PAD 450P (SAM 450P), Pad-Paks (Adult, Pediatr

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·samaritan® PAD 350P (SAM 350P), samaritan® PAD 360P (SAM 360P), samaritan® PAD 450P (SAM 450P), Pad-Paks (Adult, Pediatr

Digital Retinal Camera CR-2 Plus AF

FDA registration

CANON INC.·2 products·🇯🇵 Japan

Digital Retinal Camera CR-2 Plus AF

FDA registration

CANON COMPONENTS, INC.·2 products·🇯🇵 Japan

Digital Retinal Camera CR-2 Plus AF

FDA registration

Canon.Inc·2 products·🇯🇵 Japan

Suzhou Pac-Dent Technology Co., Ltd.

Manufacturer

🇨🇳 China·12 Basic UDI-DIs·232 Devices·2 Importers

Pal International Limited

Manufacturer

2 Importers

DLAB Scientific Co., Ltd.

Manufacturer

🇨🇳 China·3 Importers

GOLD SKY INTERNATIONAL

Manufacturer

🇵🇰 Pakistan

BioMonitor 2-AF BioMonitor 2-S FIT - Fast Insert Tool 1 + 2, Set Remote Assistant

FDA registration

BIOTRONIK, INC.·1 product·🇺🇸 United States

BioMonitor 2-AF BioMonitor 2-S FIT - Fast Insert Tool 1 + 2, Set Remote Assistant

FDA registration

BIOTRONIK SE & CO. KG·1 product·🇩🇪 Germany

APF POROUS COATED LINE EXTENSION

FDA registration

Changzhou Biomet Medical Devices Co., Ltd.·2 products·🇨🇳 China

Power Dental USA

FDA UDI

Power Dental U.S.A. Inc.·D9434801AF00·EXTRACTION FORCEPS AMERICAN 1 AF UPPER CENTRAL

T016 T017 T018 T019 T020 T021 T022 T023 T024 T025 T026 T027 T028 T029 T030

FDA registration

SHENZHEN TONYCORE TECHNOLOGY CO.,LTD.·1 product·🇨🇳 China

ROCCIA Probe/Trial

FDA registration

Silony Medical International AG·1 product·🇩🇪 Germany

Sterigenics U.S., LLC

FDA registration

Sterigenics U.S., LLC·1 product·🇺🇸 United States

Tech-Med Blood Draw Chair

FDA registration

DUKAL LLC·1 product·🇺🇸 United States

Microtek Patient Drapes with Microban

FDA registration

Microtek Medical LLC·1 product·🇺🇸 United States