14 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Manual Wheelchair
FDA 510(k)
FDA Class 1
·Physical Medicine
N/A
FDA UDI
Ortho Development Corporation·00822409129744·Uni Knee Keeled Tibial Tray Trial Size 5 Right
KSEA ELECTRONIC CO2 ENDOFLATOR LC, MODEL 26430320-1
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
STRYKER SWITCHPOINT INFINITY 3 CONTROL SYSTEM, MODEL: 067-8001-000
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CADD CASSETTE RESERVOIRS - FLOW STOP
FDA Adverse Event
Malfunction
·ST PAUL·Product code FPA·January 4, 2023
4.5MM VA-LCP CURVED CONDYLAR PLATE/6 HOLE/159MM/R
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HRS·June 20, 2013
MERCI RETRIEVER V 3.0 FIRM
FDA Adverse Event
Malfunction
·CONCENTRIC MEDICAL, INC.·Product code NRY·April 29, 2011
LIFESHIELD SYMBIQ SET WITH 2 CLAVES
FDA Adverse Event
Malfunction
·HOSPIRA DE COSTA RICA LTD.·Product code FRN·September 23, 2008
POD PACKING COIL
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code HCG·November 8, 2017
MODIFIED NOVY CORNUAL CANNULATION SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MOV·March 14, 2024
POD PACKING COIL
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code HCG·October 23, 2017
MODIFIED NOVY CORNUAL CANNULATION SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MOV·January 10, 2024
MODIFIED NOVY CORNUAL CANNULATION SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MOV·November 22, 2024
Titan Pump - Product Usage: indicated for male patients suffering from erectile dysfunction (impotence) who are considered to be candidates for implantation of a penile prosthesis.
FDA Enforcement
Class II
·Terminated·Coloplast Manufacturing US, LLC·December 2, 2020