22 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PROFEMUR GLADIATOR HA HIP STEM
FDA 510(k)
FDA Class 3
·Orthopedic
CARDINAL HEALTH
FDA UDI
Cardinal Health 200, LLC·10885380077395·1.1mm Threaded Guide Wire 150mm
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·04546540139412·PERIOSTEAL ELEVATOR, DOUBLE-ENDED, STR
Clear Readers
FDA UDI
Diversified Products, Inc.·00842894143940·
Coated Revision Stem
FDA UDI
SIGNAL MEDICAL CORPORATION·B046220811121500·12x150 Coated Revision Stem
Alliant Biotech
FDA UDI
MEDISURGE LLC·G611220811121500·Symmetric Total Knee Coated Revision Stem Size ...
SYNGO DYNAMICS, VERSION 9.0
FDA 510(k)
FDA Class 2
·Radiology
PATTON ENDO-BAG
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LUER-LOK
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMF·January 26, 2026
LUER-LOK
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMF·January 26, 2026
LUER-LOK
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMF·November 13, 2025
LUER-LOK
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMF·January 23, 2026
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·May 3, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 2, 2011
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code LDD·August 6, 2008
THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code LPB·June 6, 2018
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·January 16, 2023
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·September 7, 2022
MultiDiagnost Eleva, System codes 722030 722016 722017 708032 708036 708034 708037 708038
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020