12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TIGR Matrix Surgical Mesh, TIGR Surgical Mesh
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
U BY KOTEX CLICK* UNSCENTED TAMPONS, MODEL ABSORBENCY: REGULAR, SUPER AND SUPER PLUS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SYNGO TRUED SOFTWARE
FDA 510(k)
FDA Class 2
·Radiology
FUJIFILM DUODENOSCOPE MODEL ED-580T
FDA Adverse Event
Injury
·FUJIFILM CORPORATION·Product code FDT·September 5, 2023
FUJIFILM ENDOSCOPE
FDA Adverse Event
Malfunction
·FUJIFILM CORPORATION·Product code FDS·March 18, 2022
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 22, 2025
FUJIFILM DUODENOSCOPE ED-580T
FDA Adverse Event
Injury
·FUJIFILM CORPORATION·Product code FDT·March 5, 2025
QUICKSITE XL LV
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code OJX·January 13, 2014
RESTORATION GAP II ACET SHELL
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code LZO·June 26, 2013
TOTALCARE
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·July 28, 2011
TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems·October 10, 2018
Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018