13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BLOOD COLLECTION TUBE, GRAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
RECAP HA PRESS-FIT FEMORAL RESURFACING HEAD
FDA 510(k)
FDA Class 2
·Orthopedic
syngo Dynamics Version VA30
FDA 510(k)
FDA Class 2
·Radiology
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·October 3, 2012
ALLEGRETTO WAVE EYE-Q
FDA Adverse Event
Injury
·WAVELIGHT GMBH·Product code LZS·December 18, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·May 14, 2015
LARGE MOD HEAD ADAPT 12/14 +5
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·November 17, 2014
CORAIL2 STD SIZE 11
FDA Adverse Event
Death
·DEPUY FRANCE SAS·Product code KWA·November 17, 2014
HANDLE WITH MINI QUICK COUPLING
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWX·May 19, 2022
DEPUY ASR XL FEM IMP SIZE 46
FDA Adverse Event
Death
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·September 10, 2012
TOTAL ASR ACET IMP SIZE 52
FDA Adverse Event
Death
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·September 10, 2012
Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX. The Datex-Ohmeda S/5MT Compact Airway Module, E-CAiOVX family is used for monitoring hospital patients respiration, ventilation, and gas exchange status.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·June 25, 2014