12 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TYMPANIC TEMPERATURE SENSOR
FDA 510(k)
FDA Class 2
·General Hospital
GC Initial™
FDA UDI
Gc America Inc.·J0228732051·GC Initial™ AL Bleach Enamel, BL-E, 20g
NIO 5MP, MODEL MDNG-5121
FDA 510(k)
FDA Class 2
·Radiology
Equinox Advantage
FDA 510(k)
FDA Class 2
·Anesthesiology
SUPERA PERIPHERAL SELF-EXPANDING STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIP·June 13, 2014
BLOOD SET 4MM
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MALTA·Product code BRZ·October 18, 2010
COULTER® ACT DIFF HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code GKZ·December 13, 2012
PIPELINE FLEX
FDA Adverse Event
Malfunction
·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·December 23, 2019
PIPELINE FLEX
FDA Adverse Event
Malfunction
·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·December 23, 2019
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017
Pipeline Flex Embolization Device
FDA Enforcement
Class I
·Ongoing·Micro Therapeutics Inc,·September 15, 2021