11 results
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25ms
·
Sources: EU EUDAMED, US FDA
Neuvotion NeuStim NN-01
FDA 510(k)
FDA Class 2
·Neurology
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613018009·K-Wire, Single Ended, Trocar Point, Diameter Si...
NAIL HOLDING SCRE WGAMMA3 8X35MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·June 21, 2012
SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM, MODEL SW4000
FDA 510(k)
FDA Class 2
·Cardiovascular
TCAT TKA Instrument Tray Set
FDA 510(k)
FDA Class 2
·General Hospital
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·October 27, 2023
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
UNKNOWN·Product code ITJ·November 10, 2014
BHR
FDA Adverse Event
Injury
·SMITH & NEPHEW ORTHOPAEDICS LTD·Product code NXT·September 9, 2011
4MM DIAMOND BALL
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·July 17, 2013
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025