17 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MEDOJECT fine Pen Needles
FDA 510(k)
FDA Class 2
·General Hospital
10PW - Amazon Delivery Van Mexico - 10PW
FDA UDI
Certified Safety Manufacturing, Inc.·00766588206141·10PW - Amazon Delivery Van Mexico - 10PW
APEX PS Knee
FDA UDI
Omni Life Science, Inc.·00841690113386·PS Insert, Size 6 x 14mm
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B1676220614000·
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B1676220614150·
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B1676220614070·
IRRIGATING CANNULA
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FiteBac Antimicrobial Cavity Cleanser
FDA 510(k)
FDA Class 2
·Dental
VERSACROSS CONNECT LAAC ACCESS SOLUTION
FDA Adverse Event
Injury
·BAYLIS MEDICAL COMPANY INC.·Product code DRE·April 6, 2023
BARRIGEL INJECTABLE GEL
FDA Adverse Event
Malfunction
·PALETTE LIFE SCIENCES·Product code OVB·June 24, 2024
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·November 3, 2014
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORP·Product code MVK·July 15, 2011
IMPAX CV REPORTING
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORPORATION·Product code LLZ·July 8, 2013
SINGLE USE 8MM SCRAPER PROBE - 80MM - STERILE
FDA Adverse Event
Injury
·ORTHOFIX SRL·Product code JDX·May 27, 2024
VERSACROSS CONNECT LAAC ACCESS SOLUTION
FDA Adverse Event
Injury
·BAYLIS MEDICAL COMPANY INC.·Product code DXF·April 25, 2023
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
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020