16 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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REPROCESSED TROCARS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108699937·Bone Tap for Ø5mm Implant
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108690729·Titanium Anatomic Angulated Concave Abutment In...
ENGPLUS
FDA 510(k)
FDA Class 2
·Neurology
MFCD 118I
FDA 510(k)
FDA Class 2
·Radiology
PEN NDL 32GA 4MM 14BAG 700CASE JP
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·December 15, 2020
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·January 31, 2024
SPECTRA WAVEWRITER?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·August 6, 2025
PEN NDL 32GA 4MM 14BAG 700CASE JP
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·January 13, 2021
BD MICRO FINE PLUS INSULIN PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·January 5, 2021
ASR TAP SLV ADAP 12/14 -1
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD.·Product code KWA·March 17, 2016
CONTOUR
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·April 22, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·April 26, 2011
TALENT ABDOMINAL STENT GRAFT SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC CARDIOVASCULAR·Product code MIH·July 3, 2008
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024