14 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ADIN DENTAL IMPLANTS SYSTEM
FDA 510(k)
FDA Class 2
·Dental
TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 3
FDA 510(k)
FDA Class 2
·Physical Medicine
MEDIS 2MP2 QUAD-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
WAVEWRITER ALPHA?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·March 14, 2025
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Death
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·March 22, 2010
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·April 29, 2013
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·April 13, 2011
RSVR MMT-326A 10PK PRDGM 1.8ML 13L
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code FMF·July 18, 2008
ARCHITECT CYCLOSPORINE REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MKW·August 8, 2025
ARCHITECT CYCLOSPORINE REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MKW·September 4, 2025
ABBOTT TUBE EDTA PLH 13X75 2.0 PNK
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·August 3, 2022
ABBOTT TUBE EDTA PLH 13X75 2.0 PNK
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·September 17, 2019
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
ARCHITECT CYCLOSPORINE REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MKW·September 30, 2025