13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
AP Medical
FDA UDI
Keter Canada Inc·00875160007318·AP 50L Duo Bulk Wht Blu
Evolve Stem
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215052034·
Evolve Masters
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215002381·
LITESTREAM 500E
FDA 510(k)
FDA Class 1
·Physical Medicine
Knotless TensionTight Button Implant System
FDA 510(k)
FDA Class 2
·Orthopedic
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·November 2, 2023
BD SYRINGE WITH NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·December 20, 2017
REMB SAG SAW
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code ERL·November 11, 2014
ATLAS PLUS VR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·September 10, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 23, 2013
BD¿ 5ML SYRINGE WITH NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·January 2, 2018
Apex Knee System, Tibial Baseplate Size 6 Left, non-porous - KC-2206L The Apex Knee System is intended for use as a primary or revision total knee replacement. This knee replacement system is intended for cemented fixation and single use implantation. This prosthesis may be used for the following conditions, as appropriate: Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; Rheumatoid arthritis; Correction of functional deformity; Revision procedures where other treatments or devices have failed.
FDA Recall
Terminated
·OMNIlife science Inc.·Product code JWH·November 20, 2017