9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FLUOR PROTECTOR S
FDA 510(k)
FDA Class 2
·Dental
ArgenIS
FDA UDI
ARGEN CORPORATION, THE·D818131487·TiBase NR RP .3G E
BD SAFETYGLIDE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code MEG·July 31, 2025
MODEL AVANT 2120 PULSE OXIMETER AND NIBP
FDA 510(k)
FDA Class 2
·Cardiovascular
CHEETAH NICOM SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
KII 5X100 ZPTHR CANNULA/SEAL 12/BOX
FDA Adverse Event
Malfunction
·APPLIED MEDICAL·Product code GCJ·February 25, 2013
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·October 1, 2014
CARELINK PROGRAM W/TELEMETRY C
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code DXY·June 16, 2011
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015