23 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STABIL-O-GRAPH
FDA 510(k)
FDA Class 2
·Cardiovascular
HNM Medical
FDA UDI
HNM STAINLESS, LLC.·00842962107416·RAGNELL SCISSORS, 5", CVD
SEARCH EVOLUTION TOTAL KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
AIRDENT II CS
FDA 510(k)
FDA Class 2
·Dental
audifon
FDA UDI
audifon GmbH & Co. KG·EADF023169904131317201·BTE-TRT
QUICKVUE AT-HOME OTC COVID-19 TEST
FDA Adverse Event
Malfunction
·QUIDEL CORPORATION·Product code QKP·August 3, 2022
ADVIA CENTAUR VITAMIN D TOTAL (VITD) ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MRG·August 14, 2013
ADVIA CENTAUR XP TOXOPLASMA G (TOXO G) ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code LGD·September 18, 2013
ADVIA CENTAUR TSH3-ULTRA (TSH3-UL)
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code JLW·April 30, 2014
FLEXTEND
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·April 8, 2013
9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 23, 2011
FOOTED ATTACHMENT 2.4MM LEGEND, AF02 (B-1)
FDA Adverse Event
Malfunction
·MEDTRONIC POWERED SURGICAL SOLUTIONS·Product code HBB·May 9, 2008
OPTION TAPER SLEEVE, -3MM NECK, TYPE 1 TAPER
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·December 5, 2022
BD VERITOR SYSTEM FOR RAPID DETECTION OF FLU A + B LABORATORY KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code GNX·June 3, 2021
BD VERITOR SYSTEM FOR RAPID DETECTION OF FLU A + B LABORATORY KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code GNX·June 3, 2021
BD VERITOR SYSTEM FOR RAPID DETECTION OF FLU A + B LABORATORY KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code GNX·June 3, 2021
BD VERITOR SYSTEM FOR RAPID DETECTION OF FLU A + B LABORATORY KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code GNX·June 3, 2021
ADVIA CENTAUR XP
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code NHS·January 31, 2014
BD VERITOR SYSTEM FOR RAPID DETECTION OF FLU A + B LABORATORY KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code GNX·May 3, 2021
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly
FDA Enforcement
Class I
·Ongoing·Thoratec Corp.·May 8, 2024