15 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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Med4 Elite
FDA 510(k)
FDA Class 2
·Physical Medicine
OVUM ASPIRATION NEEDLE SINGLE LUMEN
FDA Adverse Event
Injury
·WILLIAM A. COOK AUSTRALIA, PTY LTD·Product code MQE·April 19, 2018
OVUM ASPIRATION NEEDLE SINGLE LUMEN
FDA Adverse Event
Injury
·WILLIAM A. COOK AUSTRALIA, PTY LTD·Product code MQE·April 22, 2018
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
IP-SET
FDA 510(k)
FDA Class 2
·Cardiovascular
PRECISION? MONTAGE? MRI
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·July 6, 2025
OVUM ASPIRATION NEEDLE SINGLE LUMEN
FDA Adverse Event
Injury
·WILLIAM A. COOK AUSTRALIA, PTY LTD·Product code MQE·April 18, 2018
OVUM ASPIRATION NEEDLE SINGLE LUMEN
FDA Adverse Event
Injury
·WILLIAM A. COOK AUSTRALIA, PTY LTD·Product code MQE·April 19, 2018
OVUM ASPIRATION NEEDLE SINGLE LUMEN
FDA Adverse Event
Injury
·WILLIAM A. COOK AUSTRALIA, PTY LTD·Product code MQE·April 22, 2018
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·June 15, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 22, 2011
POWERLINK SYSTEM
FDA Adverse Event
Malfunction
·ENDOLOGIX, INC.·Product code MIH·October 15, 2014
UNKNOWN_NEUWAVE
FDA Adverse Event
Injury
·NEUWAVE MEDICAL, INC.·Product code NEY·March 18, 2019
CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-0105-03L c. 21-2120-0105-06L d. 21-2120-0105-07L e. 21-2120-0105-08L f. 21-2120-0105-12L g. 21-2120-0105-13L h. 21-2120-0105-14L i. 21-2120-0105-15L j. 21-2120-0105-17L k. 21-2120-0105-50L l. 21-2127-0105-02L m. 21-2127-0105-06L n. 21-2127-0105-50L
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD Inc.·October 27, 2021
Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781342 781377
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021