783 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SYRINGE TIP CONNECTOR
FDA 510(k)
FDA Class 1
·General Hospital
MARS Monitor
FDA UDI
GAMBRO AB·37332414106936·The MARS Monitor is a mechanical detoxification...
MGB Alert® Bordetella P/PP Primer Mix ASR - 48 Reactions
FDA UDI
Elitechgroup Mdx LLC·03661540951961·"MGB Alert® B. pertussis / B. parapertussis Pri...
ACUMED
FDA UDI
Acumed LLC·10806378042188·Calcaneal Plate Tray
INTERVENTIONAL BODY COIL
FDA 510(k)
FDA Class 2
·Radiology
MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 CERECYTE, MODEL CDF
FDA 510(k)
FDA Class 2
·Neurology
BIODESIGN URETHRAL SLING
FDA Adverse Event
Injury
·COOK BIOTECH, INC.·Product code PAG·April 3, 2014
PRODISC-C IMPLANT MEDIUM DEEP 5MM-STERILE
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code MJO·October 17, 2012
VALIANT CAPTIVIA - CW
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·May 27, 2015
LIGHT DIAGNOSTICS SimulFluor Flu A/Flu B DFA Kit Immunofluorescence Assay Cat. No. 3121 FOR IN VITRO DIAGNOSTIC USE Authorized Representative: Millipore (UK) Ltd. Fleming Road, Kirkton Campus Livingston EH54 7BN UK. Tel +44 1506 404000 Fax +44 1506 404073 MILLIPORE 28820 Single Oak Drive Temecula, CA 92590 " USA & Canada Phone: +1(800) 437-7500 " Fax: +1 (951) 676-9209. The kit consists of Catalog #5250 Simulfluor Flu A/B; Catalog #5010 Flu A/B Control Slide; Catalog #5013 Mounting Fluid; Catalog #5037 Tween 20/Sodium Azide, 100X; Catalog #5087 PBS Packet
FDA Recall
Terminated
·Millipore Corporation·Product code GNW·November 24, 2008
GE Healthcare, Proteus XR/a. Proteus XR/a Intended Use: Is intended for use in generating radiographic images of human anatomy in all general purpose diagnostic procedures. This device is not intended for mammographic applications.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code KPR·June 4, 2014
INFINITY DUAL HEMO MCable Pod
FDA Recall
Terminated
·Draegar Medical Systems, Inc.·Product code MHX·October 4, 2017
GE Healthcare, Revolution XR/d. Revolution XR/d Intended Use: The Revolution XR/d Digital Radiographic imaging system is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammographic applications.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code KPR·June 4, 2014
Carina Ventilator, ventilator. Catalog no. 5704110. Long-term ventilator for treatment in hospitals by a qualified medical personnel.
FDA Recall
Terminated
·Draeger Medical, Inc.·Product code CBK·April 26, 2018
Centricity Enterprise Web 3.0 software; the software allows physicians convenient, quick access to medical images and related data they need via a web browser, password and a standard PC; GE Healthcare Integrated IT Solutions, Barrington, IL 60010.
FDA Recall
Terminated
·GE Healthcare Integrated IT Solutions·Product code LMD·December 12, 2008
Fabius Tiro M, anesthesia machine, catalog no. 8608400 Product Usage: The products are inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fabius series anesthesia machines are equipped with an electrically driven and electronically controlled ventilator and monitors for airway pressure (P), volume (V), and inspiratory oxygen concentration (FiO2).
FDA Recall
Terminated
·Draeger Medical, Inc.·Product code BSZ·March 1, 2018
Fabius Tiro, anesthesia machine, catalog no. 8606000 Product Usage: The products are inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fabius series anesthesia machines are equipped with an electrically driven and electronically controlled ventilator and monitors for airway pressure (P), volume (V), and inspiratory oxygen concentration (FiO2).
FDA Recall
Terminated
·Draeger Medical, Inc.·Product code BSZ·March 1, 2018
Fabius GS Premium, anesthesia machine, catalog no. 8607000 Product Usage: The products are inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fabius series anesthesia machines are equipped with an electrically driven and electronically controlled ventilator and monitors for airway pressure (P), volume (V), and inspiratory oxygen concentration (FiO2).
FDA Recall
Terminated
·Draeger Medical, Inc.·Product code BSZ·March 1, 2018
Senographe Pristina
FDA Recall
Open, Classified
·GE Medical Systems, SCS·Product code MUE·December 26, 2023
Fabius MRI, anesthesia machine, catalog no. 8607300 Product Usage: The products are inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fabius series anesthesia machines are equipped with an electrically driven and electronically controlled ventilator and monitors for airway pressure (P), volume (V), and inspiratory oxygen concentration (FiO2). This device can also be used in MRI scanner rooms with magnets 1.5 tesla and 3 tesla at a fringe field strength of 40 mtesla or less.
FDA Recall
Terminated
·Draeger Medical, Inc.·Product code BSZ·March 1, 2018