14 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS
FDA 510(k)
FDA Class 2
·Hematology
Oticon
FDA UDI
Oticon A/S·05707131282996·RIA2 PRO, MINIBTE 312 WL 85 CBE
CORONARY SINUS DEFLECTABLE MAPPING CATHETER, 4 FR, 5 FR, 6 FR & 7 FR
FDA 510(k)
FDA Class 2
·Cardiovascular
MICROMANIPULATOR SET
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
VITALITY 2
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 8, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·June 6, 2013
HIP HEAD,10/12 TAPER,28MM,+0MM
FDA Adverse Event
Injury
·DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS·Product code KWY·June 29, 2011
14 SHIDEN HP
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·September 26, 2024
14 SHIDEN HP
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·February 4, 2025
14 SHIDEN HP
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·February 13, 2025
VERSAFITCUP ACETABULAR SHELL Ø 46
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·May 23, 2017
ARTOURA BREAST TISSUE EXPANDER
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code LCJ·August 21, 2023
14 SHIDEN HP
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·June 20, 2025
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