44 results · 52ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

DIGIMED CO., LTD

FDA registration
DIGIMED CO., LTD·1 product·🇰🇷 South Korea

PROX

FDA UDI
DigiMed Co., Ltd.·08800021800007·The PROX is a hand-held diagnostic dental x-ray...

MiniX-S

FDA UDI
DigiMed Co., Ltd.·08800021800021·The MiniX-S is an x-ray generating device which...

DHX-70H

FDA UDI
DigiMed Co., Ltd.·08800021800137·The portable x-ray system, DHX-70H is an x-ray ...

DIOX-602

FDA UDI
DigiMed Co., Ltd.·08800021800014·The DIOX-602 is a hand-held diagnostic dental x...

BIOX

FDA UDI
DigiMed Co., Ltd.·08800021800045·The portable x-ray system, BIOX is an x-ray gen...

xm-lite

FDA UDI
DigiMed Co., Ltd.·08800021800113·The portable x-ray system, HYBRID C70 is an x-r...

XTG PRO 70

FDA UDI
DigiMed Co., Ltd.·08800021800120·The portable x-ray system, HYBRID Pro is an x-r...

HYBRID S70

FDA UDI
DigiMed Co., Ltd.·08800021800106·The portable x-ray system, HYBRID S70 is an x-r...

MiniX-V

FDA UDI
DigiMed Co., Ltd.·08800021800038·The MiniX-V is a hand-held diagnostic dental x-...

Portable X-ray system

FDA Recall
Open, Classified ·DIGIMED CO., LTD 401, 402, 406~411-ho, A-dong 101, Gasan digital 2-ro, Geumcheon-Gu Seoul Korea (the Republic of)·Product code EHD·June 19, 2025

Portable X-ray system

FDA Enforcement
Class II ·Ongoing·DIGIMED CO., LTD·July 30, 2025

RUICHUANGKE DIGITAL CO. LTD

FDA registration
RUICHUANGKE DIGITAL CO. LTD·1 product·🇨🇳 China

SUNSTAR DIGI (H.K.) CO., LTD

FDA registration
SUNSTAR DIGI (H.K.) CO., LTD·1 product·🇨🇳 China

SHENZHEN 3NOD DIGITAL TECHNOLOGY CO., LTD

FDA registration
SHENZHEN 3NOD DIGITAL TECHNOLOGY CO., LTD·1 product·🇨🇳 China

SHENZHEN KESITE DIGITAL TECHNOLOGY CO., LTD.

FDA registration
SHENZHEN KESITE DIGITAL TECHNOLOGY CO., LTD.·3 products·🇨🇳 China

CARERAY DIGITAL MEDICAL TECHNOLOGY CO., LTD.

FDA registration
CARERAY DIGITAL MEDICAL TECHNOLOGY CO., LTD.·2 products·🇨🇳 China

SHENZHEN RANVOO DIGITAL TECHNOLOGY CO., LTD.

FDA registration
SHENZHEN RANVOO DIGITAL TECHNOLOGY CO., LTD.·1 product·🇨🇳 China

GUANGZHOU SOWEN DIGITAL TECHNOLOGY CO., LTD.

FDA registration
GUANGZHOU SOWEN DIGITAL TECHNOLOGY CO., LTD.·1 product·🇨🇳 China

X-ray Flat Panel Detector

FDA UDI
CareRay Digital Medical Technology Co., Ltd.·06970597830097·