7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DRAVON T CLAMP
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
STERICAN CANNULA
FDA 510(k)
FDA Class 2
·General Hospital
SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL S.A.,·Product code GEY·March 6, 2014
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·November 9, 2012
RESTORE RECHARGABLE NEUROSTIMULATOR
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·September 8, 2010
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024