1,239 results · 20ms · Sources: EU EUDAMED, US FDA

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Dongguan CFE Electronic Co., Ltd

FDA registration
Dongguan CFE Electronic Co., Ltd·2 products·🇨🇳 China

CAO (CHINA) MEDICAL EQUIPMENT COMPANY, LIMITED

FDA registration
CAO (CHINA) MEDICAL EQUIPMENT COMPANY, LIMITED·6 products·🇨🇳 China

AFO

Device
EU MDR · Eu Md Class 1 ·Xiamen LongStar Medical Equipment Co., Ltd·On the market

AFO

Device
EU MDR · Eu Md Class 1 ·Xiamen LongStar Medical Equipment Co., Ltd·On the market

AFO

Device
EU MDR · Eu Md Class 1 ·Xiamen LongStar Medical Equipment Co., Ltd·On the market

AFO

Device
EU MDR · Eu Md Class 1 ·Xiamen LongStar Medical Equipment Co., Ltd·On the market

OPHTHALMIC DEVICES - OTHER

Device
EU MDR · Eu Md Class 1 ·CJO(Shanghai) Technology Co., Ltd·On the market·32 countries

AFO

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Xiamen LongStar Medical Equipment Co., Ltd·1 device

AFO

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Xiamen LongStar Medical Equipment Co., Ltd·1 device

AFO

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Xiamen LongStar Medical Equipment Co., Ltd·1 device

AFO

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Xiamen LongStar Medical Equipment Co., Ltd·1 device

Easy-CF2

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Pilot Gene Technology (Hangzhou) Co., Ltd·1 device

Mirror Chart

Basic UDI-DI
EU MDR · Eu Md Class 1 ·CJO(Shanghai) Technology Co., Ltd·1 device

Hermes NC PTA Balloon Dilatation Catheter The balloon dilatation catheter is intended to dilate stenoses in the iliac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent dilatation post-deployment in the peripheral vasculature.

FDA Enforcement
Class II ·Terminated·BrosMed Medical Co.,Ltd.·March 6, 2019

Nimbus 4 and Nimbus Professional Alternating-pressure bed mattress overlay system

FDA Enforcement
Class II ·Terminated·Getinge (Suzhou) Co Ltd·June 9, 2021

Philips Incisive CT

FDA Enforcement
Class II ·Ongoing·Philips Healthcare (Suzhou) Co., Ltd.·January 14, 2026

Brand Name: Pluslife SARS-CoV-2 Card Product Name: SARS-CoV-2 Nucleic Acid Testing Card Model/Catalog Number: RM1010202 Software Version: N/A Product Description: 1. Product Overview Product Name: SARS-CoV-2 Nucleic Acid Testing Card Trade Name: Pluslife SARS-CoV-2 Card 2.Product composition:The kits consists of SARS-CoV-2 Reaction Card (10 pcs), Nucleic Acid ReleasingAgent 01 (10 pcs), Disposable SamplingSwab (10 pcs), and Waste Bag (10 pcs). Component: NO

FDA Enforcement
Class II ·Ongoing·Guangzhou Pluslife Biotech Co., Ltd.·June 25, 2025

Brand Name: MiniDock Product Name: Integrated Nucleic Acid Testing Device Model/Catalog Number: PM001 Software Version: N/A Product Description: 1. Product Overview 1.1 Product Name: Integrated Nucleic Acid Testing Device Brand Name: MiniDock 1.2 Model: PM001 2.Product composition: This device consists of the main unit, power cord, data cable, power adapter, chip bracket, and instruction manual packaging. Component: No

FDA Enforcement
Class II ·Ongoing·Guangzhou Pluslife Biotech Co., Ltd.·June 25, 2025

CMS8000 Patient Monitor

FDA Enforcement
Class II ·Ongoing·Contec Medical Systems Co., Ltd.·May 21, 2025

AcoSound. Model Number: LW12-BTE-M

FDA Enforcement
Class III ·Ongoing·HANGZHOU ACOSOUND TECHNOLOGY CO., LTD.·June 25, 2025