8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Knotilus+ PEEK Knotless Anchor
FDA 510(k)
FDA Class 2
·Orthopedic
ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System, ACUSON Freestyle Diagnostic Ultrasound System,ACUSON S1000, S2000, S3000 Diagnostic Ultrasound Systems, ACUSON P200 Diagnostic Ultrasound System, ACUSON P500 Diagnostic Ultrasound System, ACUSON NX3, NX3 Elite Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
GENESIS II POROUS PLUS HA KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·September 27, 2023
MILLER ENEMA AIR TIP
FDA Adverse Event
Malfunction
·E-ZEM, INC.·Product code FGD·November 10, 2008
PINNACLE MTL INS NEUT36IDX54OD
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS INC US·Product code KWA·August 18, 2011
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 18, 2013
K-Wire Trochar Tip, Model Number 212000008 Product Usage: These DVR Express Disposable Instruments are used to facilitate implantation of orthopedic medical devices in trauma.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·July 10, 2019