48 results
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57ms
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Sources: EU EUDAMED, US FDA
WEINMANN Emergency Medical Technology GmbH + Co. KG
Manufacturer
🇩🇪 Germany
Tianjin A-Shield Emergency Medical Technology Pty Ltd
Manufacturer
🇨🇳 China
WEINMANN EMERGENCY MEDICAL TECHNOLOGY GMBH
FDA registration
WEINMANN EMERGENCY MEDICAL TECHNOLOGY GMBH·1 product·🇩🇪 Germany
Low-pressurehose assembly, 2m, 02 green DISS/ DISS
FDA UDI
WEINMANN Emergency Medical Technology GmbH + Co. KG·04054685271589·
Low-pressurehose assembly, 2m, 02 green DISS/ OHMEDA
FDA UDI
WEINMANN Emergency Medical Technology GmbH + Co. KG·04054685271619·
MEDUMAT Easy CPR
FDA UDI
WEINMANN Emergency Medical Technology GmbH + Co. KG·04054685268947·
Low-pressurehose assembly, 2m, 02 green DISS/ PURITAN BENNET
FDA UDI
WEINMANN Emergency Medical Technology GmbH + Co. KG·04054685271602·
Low-pressurehose assembly, 2m, 02 green DISS/ CHEMETRON
FDA UDI
WEINMANN Emergency Medical Technology GmbH + Co. KG·04054685271596·
MEDUtrigger
FDA UDI
WEINMANN Emergency Medical Technology GmbH + Co. KG·04054685091286·
Disposable breathing circuit, 1.70m
FDA UDI
WEINMANN Emergency Medical Technology GmbH + Co. KG·04054685129996·
MEDUtrigger
FDA UDI
WEINMANN Emergency Medical Technology GmbH + Co. KG·04054685091408·
CLASSYS
Manufacturer
🇰🇷 South Korea·2 Importers
APTIMA SARS-COV-2 ASSAY
FDA Adverse Event
Malfunction
·HOLOGIC INCORPORATED·Product code QJR·May 19, 2022
LIFEPAK CR2 Part / Catalog Numbers / UDI-DI code: CR2-2-001451 99512-001434 883873785911 LIFEPAK CR2: The LIFEPAK CR2 defibrillator is indicated for use on patients 1 year of age or older in cardiopulmonary arrest. The patient must be unresponsive (unconscious), not breathing normally, and showing no signs of circulation (for example, no pulse, no coughing, or no movement). The cprCOACHTM Feedback Technology in the LIFEPAK CR2 defibrillator is indicated for use on cardiopulmonary arrest patients and provides CPR guidance in accordance with the AHA Guidelines for patients 1 year of age or older. The LIFEPAK CR2 defibrillator is intended for use by personnel who have been trained in its operation. Users should have received training in basic life support/AED, advanced life support, or a physician-authorized emergency medical response training program.
FDA Enforcement
Class II
·Ongoing·Physio-Control, Inc.·September 10, 2025
WEINMANN Emergency Medical Technology GmbH + Co. KG
Importer
🇩🇪 Germany
GRZAN GROUP SL
Authorized representative
🇪🇸 Spain·31 Manufacturers·130 Devices
LIFEPAK CR Plus Automated External Defibrillator. Device is primarily deployed in Public Access Defibrillator (PAD). It is a small lightweight device intended for use by minimally trained responders to treat victims of sudden cardiac arrest... Product is capable of 30 full discharges. Labeling on the device states LIFEPAK CR Plus LIFEPAK EXPRESS Defibrillators with ADAPTIV Biphasic Technology; Medtronic Emergency Response Systems, Inc. 11811 Willows Road NE Redmond, WA.
FDA Recall
Terminated
·Physio Control, Inc.·Product code MJK·August 28, 2008
Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 (The system consists of an a monoplane Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. Also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. Intended to replace fluoroscopic images obtained through image intensifier technology.
FDA Recall
Terminated
·GE Healthcare·Product code MQB·July 25, 2008
Innova 2000; The principle system components include a C-arm, image acquisition, processing and archiving capabilities. Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. Also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. Intended to replace fluoroscopic images obtained through image intensifier technology.
FDA Recall
Terminated
·GE Healthcare·Product code MQB·July 25, 2008
Innova 2100IQ (The Digital Fluoroscopic Imaging System consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector) Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. Also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. Intended to replace fluoroscopic images obtained through image intensifier technology.
FDA Recall
Terminated
·GE Healthcare·Product code MQB·July 25, 2008