13 results
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34ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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COALITION SPACER
FDA 510(k)
FDA Class 2
·Orthopedic
ArgenIS
FDA UDI
ARGEN CORPORATION, THE·D818131449·MUA NC RP 1.5GH Str
MODIFICATION TO THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION
FDA 510(k)
FDA Class 2
·Orthopedic
INTELLIVUE PATIENT MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
ARTICULEZE M HEAD 36MM -2
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JDI·June 19, 2013
PINNACLE MTL INS NEUT36IDX50OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910 ·Product code KWA·June 19, 2013
PARIETEX UGYTEX PP 15X10CM X1
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code FTL·May 10, 2013
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·June 16, 2011
INGEVITY
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVN·October 1, 2014
ASPHERE M SPEC 11/13 36 -3
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JDI·December 11, 2013
PINNACLE MTL INS NEUT36IDX50OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·December 11, 2013
40" (102 CM) APPX 5.3 ML ADMIN SET W/2 CHEMOLOCK¿
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FPA·June 13, 2025
Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare Inc·May 13, 2015