12 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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2 Face / Face Evolution
FDA 510(k)
FDA Class 2
·Neurology
BELIFU
FDA Adverse Event
Injury
·HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED·Product code GZJ·February 10, 2020
Nasal Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668108543·NASAL SPECULUM CHILD
AED
FDA UDI
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657019149·Knife toothed curved 30 degree left
BIOPSY VALVE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
COILS, MODELS MCF-B65, MCF-75, MCF-125 AND COOL-B65
FDA 510(k)
FDA Class 2
·Neurology
ISA CO2
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code MWI·December 30, 2022
PENUMBRA COIL 400
FDA Adverse Event
Injury
·PENUMBRA, INC.·Product code HCG·November 29, 2016
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 22, 2011
PAINSMART IOD
FDA Adverse Event
Malfunction
·MOOG DEVICE GROUP·Product code FRN·May 23, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 15, 2014
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