12 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PERFECTA TOTAL HIP SYSTEM, CERAMIC FEMORAL HEAD
FDA 510(k)
FDA Class 2
·Orthopedic
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471122932·K-WIRE - DOUBLE TROCAR 1.25mm DIA x 150mm
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123274·K-WIRE - DOUBLE TROCAR 1.8mm DIA x 150mm
N/A
FDA UDI
PENTAX OF AMERICA, INC.·04961333242467·CABLE RGB TO EPK-1000
PREGNANCY (W) EDGE
FDA 510(k)
FDA Class 1
·Physical Medicine
Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus
FDA 510(k)
FDA Class 2
·Anesthesiology
B1005, ACUCISE ENDOPYELOTOMY SYSTEM
FDA Adverse Event
Malfunction
·APPLIED MEDICAL RESOURCES·Product code EYB·April 17, 2017
MONARC SLING SYSTEM
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·January 15, 2013
PUMP MMT-522NAS PRDGM INS V2.2 SK EN
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·December 6, 2010
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code DTB·July 9, 2014
LIGACLIP
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·September 26, 2017
The Quidel Triage BNP Calibrators
FDA Enforcement
Class II
·Terminated·Medline Industries Inc·November 4, 2020