14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Ventana L Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
Intrigue
FDA UDI
LANCER ORTHODONTICS, INC.·00817573021444·INTRG WHISP MBT CUS HK 0T +3A 018 LL
Rx Knee Femoral Cone Augment Reamer Size Large
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215147839·
980 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN·Product code CBK·December 14, 2016
ONE TOUCH ULTRA
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·December 20, 2005
PURITAN BENNETT 980 SERIES VENTILATOR SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
Spectralis HRA+OCT and variants
FDA 510(k)
FDA Class 2
·Ophthalmic
GE OEC 9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·November 13, 2008
GORE EXCLUDER AAA ENDOPROSTHESIS
FDA Adverse Event
Malfunction
·W.L. GORE & ASSOCIATES·Product code MIH·July 25, 2011
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·July 17, 2013
KIDS OXYGENATOR D101
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·April 4, 2025
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022
RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025