17 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical Instrument
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AED
FDA UDI
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657019217·Hook probe angled 90 degree working end
Orbit Depressor
FDA UDI
KATENA PRODUCTS, INC.·00841668100912·SCHOCKET SCLERAL DEPRESSOR
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
CRYOBALLOON ABLATION SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ENDO GIA(TM) STAPLERS, DST SERIES(TM) GIA(TM) STAPLERS, DST SERIES(TM) TA(TM) STAPLERS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
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
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 15, 2014
PAINSMART IOD
FDA Adverse Event
Malfunction
·MOOG DEVICE GROUP·Product code FRN·May 23, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 22, 2011
TRI-STAPLE 2.0
FDA Adverse Event
Malfunction
·COVIDIEN LP LLC NORTH HAVEN·Product code GDW·February 13, 2024
LIBRE 2 SENSOR FREESTYLE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC·Product code QLG·February 9, 2024
RING TRANSJUGULAR INTRAHEPATIC ACCESS SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·November 15, 2019
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