15 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Carescape B850, E-musb
FDA 510(k)
FDA Class 2
·Cardiovascular
LuxaCore® Z Dual
FDA UDI
DMG Chemisch-Pharmazeutische Fabrik GmbH·EDMG2133360·Core build-up composite with zirconium oxide an...
CD-Chex CD34
FDA UDI
STRECK, INC.·20844509000468·A positive procedural control for enumerating C...
XANTALGIN CRONO
FDA 510(k)
FDA Class 2
·Dental
Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30
FDA 510(k)
FDA Class 2
·Microbiology
CLARIUS ULTRASOUND SCANNER
FDA Adverse Event
Malfunction
·CLARIUS MOBILE HEALTH CORP.·Product code IYN·October 17, 2024
SENSOR ENLITE
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OZO·October 13, 2014
ASR UNI FEMORAL IMPL SIZE 49
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·August 12, 2011
STONELIGHT LASER SYSTEM
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS·Product code GEX·July 3, 2013
LIFE SCOPE G9
FDA Adverse Event
Malfunction
·NIHON KOHDEN CORPORATION·Product code MHX·June 13, 2024
LIFE SCOPE G9
FDA Adverse Event
Malfunction
·NIHON KOHDEN CORPORATION·Product code MHX·October 27, 2023
LAPIPLASTY 4.0MM FULLY THREADED SCREW
FDA Adverse Event
Injury
·TREACE MEDICAL CONCEPTS, INC.·Product code HWC·March 14, 2025
CustMbite, Model Number CBT-SRS-UL
FDA Enforcement
Class II
·Ongoing·Dental Choice Holding Llc·August 10, 2022
Philips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221, 722229), Azurion 3 M15 (722222, 722230), Azurion 5 (722281), Azurion 5 M12 (722227, 722231), Azurion 5 M20 (722228, 722232, 722281), Azurion 7 (722282), Azurion 7 B12 (722225, 722235), Azurion 7 B20 (722068, 722226, 722236), Azurion 7 M12 (722078, 722223, 722233), Azurion 7 M20 (722079, 722224, 722234, 722282).
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 20, 2026
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023