10 results
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19ms
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Sources: EU EUDAMED, US FDA
URIC ACID, BOUND ENZYME
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Hillrom™
FDA UDI
Baxter Medical Systems GmbH + Co. KG·00887761990494·Trumpf Medical/Medizin Leg section short one pa...
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690127345·Apex Revision Knee System-Revision Tibia Trials...
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690194927·Apex Revision Knee System-Revision Tibia Trials...
SOCKIT! AND MCMERLIN DERMAL WOUND GEL
FDA 510(k)
FDA Unclassified
·Unknown
UNiD Patient specific 3D printed TLIF cage
FDA 510(k)
FDA Class 2
·Orthopedic
ECHELON LINEAR CUTTER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·May 5, 2014
ADAPTA DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NVZ·October 15, 2012
UNKNOWN DEPUY SMARTSET CEMENT
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LOD·August 5, 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