19 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VERACIA SA
FDA 510(k)
FDA Class 2
·Dental
Sentry
FDA UDI
Life Spine, Inc.·00190837034368·T-Handle
CapSure® Spine System
FDA UDI
Spine Wave, Inc.·10840642104684·PS3 Screw 4.5mm x 25mm
MOONRAY MOBILE C-ARM
FDA 510(k)
FDA Class 2
·Radiology
LITE PELVIC FLOOR REPAIR KITS
FDA 510(k)
FDA Class 3
·Obstetrics/Gynecology
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FPA·May 15, 2013
HOME CHOICEPRO
FDA Adverse Event
Death
·BAXTER HEALTHCARE - LARGO·Product code FKX·September 24, 2014
RENAISSANCE 26
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·May 25, 2011
NEEDLE, HYPODERMIC, SINGLE LUMEN
FDA Adverse Event
Malfunction
·TERUMO PHILIPPINES CORPORATION·Product code FMI·September 1, 2020
TERUMO SURGUARD3 SAFETY HYPODERMIC NEEDLE
FDA Adverse Event
Malfunction
·TERUMO PHILIPPINES CORPORATION·Product code FMI·August 28, 2018
MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X30 LONG HEAD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code OVD·December 19, 2022
NEEDLE, HYPODERMIC, SINGLE LUMEN
FDA Adverse Event
Malfunction
·TERUMO PHILIPPINES CORPORATION·Product code FMI·November 8, 2019
TERUMO SURGUARD3 SAFETY HYPODERMIC NEEDLE
FDA Adverse Event
Malfunction
·TERUMO PHILIPPINES CORPORATION·Product code FMI·November 13, 2018
SURGUARD3 SAFETY HYPODERMIC NEEDLE
FDA Adverse Event
Malfunction
·TERUMO PHILIPPINES CORPORATION·Product code FMI·December 6, 2024
1.55MM X 10MM FLUTED TWIST DRL
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBE·October 17, 2016
1.55MM X 10MM FLUTED TWIST DRL
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBE·October 17, 2016
TERUMO SURGUARD3 SAFETY HYPODERMIC NEEDLE
FDA Adverse Event
Malfunction
·TERUMO PHILIPPINES CORPORATION·Product code FMI·December 2, 2022
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
Model Number L131, ESSENTIO DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025