9 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INNOVANCE D-DIMER AND INNOVANCE D-DIMER CONTROLS
FDA 510(k)
FDA Class 2
·Hematology
Deploy™ Expandable Interbody System
FDA UDI
Southern Spine LLC·00815351022577·Lumbar Expandable Cage, 8 Degree, 32mm Length, ...
DHF 0.2 HEMOCONCENTRATOR: DIDECO NEWBORN-INFANT HEMONCENTRATION; DHR 0.6 HEMOCONCENTRATOR: DIDECO PEDIATRIC/SMALL ADULT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EBI ACUMEN SURGICAL NAVIGATION SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
DHF 06 HEMOCONCENTRATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALY·Product code KDI·May 22, 2025
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·April 29, 2013
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORP.·Product code MKJ·April 12, 2011
ACCODLADE (127 DEG) SIZE 4.5 ACCOLADE (127 DEG) SIZ
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS CORK·Product code MEH·July 18, 2008
GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-Strasse 1-5, Schonkirchen, Germany 24232; T2 K-Wire, Sterile R Intended for the temporary stabilization of bone segments or fragments
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·December 28, 2016