21 results
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31ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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KATALYST REVOLVER LASER PROBES, KATALYST REVOLVER ILLUMINATED LASER PROBES, KATALYST REVOLVER ILLUMINATED PROBES
FDA 510(k)
FDA Class 2
·Ophthalmic
QCT Pro Asynchronous Calibration Module, CliniQCT
FDA UDI
MINDWAYS SOFTWARE, INC.·B052DIASYNC0·The QCT Pro Asynchronous Calibration Module is ...
Fuji Cervical Plate System
FDA UDI
Altus Spine, LLC·B41711403621·62mm Level 3 Cervical Plate System - Fuji
Semken Tissue Forceps
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896121218·Semken Tissue Forceps With Tungsten Carbide Ser...
CERVICAL PLATE VARIABLE SELF-DRILLING SCREW DIAM. 4X16MM (2X)
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code KWQ·November 10, 2016
CERVICAL PLATE FIXED SELF-TAPPING SCREW DIAM. 4X14MM (2X)
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KWQ·September 13, 2018
CAMBRIDGE HEART OEM
FDA 510(k)
FDA Class 2
·Cardiovascular
DIAPHARMA FACTOR X KIT
FDA 510(k)
FDA Class 2
·Hematology
LOGIC FEMORAL PS POR RIGHT SZ 2
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·February 10, 2025
MECTA C VARIABLE SELF-DRILLING SCREW DIAM. 4X18MM (2X)
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code KWQ·June 24, 2022
CERVICAL PLATE VARIABLE SELF-TAPPING SCREW DIAM. 4X14MM (2X)
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KWQ·June 8, 2018
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·October 3, 2014
ENDURANT
FDA Adverse Event
Death
·MEDTRONIC IRELAND·Product code MIH·May 31, 2013
LUMAX 300 HF-T
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code NIK·June 17, 2011
LOGIC CR FEMORAL POR, LEFT, SZ 3.5
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·December 11, 2024
UNKNOWN COVIDIEN NEUROVASCULAR MICROCATHETER
FDA Adverse Event
Injury
·COVIDIEN (IRVINE)·Product code KRA·November 1, 2016
ONYX
FDA Adverse Event
Death
·COVIDIEN (IRVINE)·Product code MFE·November 2, 2016
ONYX
FDA Adverse Event
Injury
·COVIDIEN (IRVINE)·Product code MFE·November 1, 2016
ONYX
FDA Adverse Event
Injury
·COVIDIEN (IRVINE)·Product code MFE·November 2, 2016
CERVICAL PLATE FIXED SELF-TAPPING SCREW DIAM. 4X18MM (2X)
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code KWQ·September 15, 2021