14 results
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19ms
·
Sources: EU EUDAMED, US FDA
AMP AUTOMATIC CYCLER STAND
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Hillrom™
FDA UDI
Baxter Medical Systems GmbH + Co. KG·00887761990487·Trumpf Medical/Medizin Leg section one part sho...
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690127338·Apex Revision Knee System-Revision Tibia Instru...
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690194996·Apex Revision Knee System-Revision Tibia Instru...
Diapaste
FDA 510(k)
FDA Class 2
·Dental
OLECRANAIL INTRAMEDULLARY FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35 WIRE, 12, STERILE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GCP·August 11, 2021
SENSOR ENLITE
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OZO·May 5, 2014
CARELINK
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code KRG·October 15, 2012
DURALOC CONST LINER 58/70X32
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JDI·August 5, 2010
HF-RESECTION ELECTRODE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GCP·March 8, 2023
TELESCOPE, 3 MM, 30°, WIDEANGLE, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GCP·April 25, 2023
HF-RESECTION ELECTRODE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GCP·March 8, 2023
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