22 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti, Actiflip Naked, Actiflip Cinch, Actiflip Whip, and GFS Ultimate Hip
FDA 510(k)
FDA Class 2
·Orthopedic
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112946·CORNEAL TREPHINE BLADE8.25MM
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112526·BARRON VACUUM TREPHINE 8.25MM
Vilex Power Accessory
FDA UDI
VILEX IN TENNESSEE, INC.·00841731122308·KWire .078 x 9"(2.0x225mm))
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973677·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970034·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973004·
Headless Compression Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
DENTAL COMPUTED TOMOGRAPHY X-RAY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
OMNIPOD INSULIN MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·August 9, 2021
PLV-100
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code CBK·June 28, 2013
TENDRIL SDX
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC.,CARDIAC RHYTHM MANAGEMENT DIVISI·Product code NVN·January 13, 2014
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·August 2, 2011
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·May 19, 2022
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·May 24, 2022
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·July 2, 2022
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·September 9, 2022
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·October 19, 2022
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code QJR·September 8, 2020
POLYPROYLENE SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAW·November 11, 2024