13 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NMI COAXIAL MICROINTRODUCER SET
FDA 510(k)
FDA Class 2
·Cardiovascular
PIVOX™ Oblique Lateral Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169606586·SPACER 2123445 O25 23.5MM 18 DEG 14X45
ATRAMAT
FDA UDI
Internacional Farmacéutica, S.A. de C.V.·07500142068775·ATRAMAT SILK SURGICAL SUTURE BLACK USP 4-0 EP 1...
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970577·
ALACER SURGICAL SCAFFOLD
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TRACERS BONE CEMENT OPACIFIER
FDA 510(k)
FDA Class 2
·Neurology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 20, 2025
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 21, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 26, 2014
LOGICAL SINGLE KIT
FDA Adverse Event
Malfunction
·SMITHS MEDICAL INTERNATIONAL LTD.·Product code DRS·June 9, 2011
BAIR HUGGER / 3M
FDA Adverse Event
Injury
·3M·Product code DWJ·November 23, 2016
X-Celerator Hydrophilic Exchange Guidewire Catalog No. 103-0601-300 103-0601-350V10 103-0602-350V06 103-0601-300V01 103-0602-300 103-0602-350V09 103-0601-300V02 103-0602-300V01 103-0602-350V10 103-0601-300V03 103-0602-300V02 103-0601-300V06 103-0602-300v06 103-0601-300V10 103-0602-300V09 103-0601-300V11 103-0602-300V10 103-0601-350 103-0602-350 103-0601-350V01 103-0602-350V01 103-0601-350V06 103-0602-350V02
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016
Discovery MR750w 3.0T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0 to DV26.5, DV29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·August 14, 2024