15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FORTE, MODELS CPS 400 STIM, CPS 200 STIM
FDA 510(k)
FDA Class 2
·Physical Medicine
SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CADD LEGACY PUMP
FDA Adverse Event
Malfunction
·ST PAUL·Product code FRN·April 11, 2022
CADD LEGACY PLUS PUMP
FDA Adverse Event
Malfunction
·ST PAUL·Product code FRN·September 8, 2022
CADD LEGACY PLUS PUMP
FDA Adverse Event
Malfunction
·ST PAUL·Product code FRN·September 23, 2022
CADD LEGACY PLUS PUMP
FDA Adverse Event
Malfunction
·ST PAUL·Product code FRN·September 22, 2022
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·June 13, 2014
UNKNOWN IMPLANTABLE NEUROSTIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code EZW·February 28, 2013
ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BZE·February 9, 2011
CADD LEGACY PLUS PUMP
FDA Adverse Event
Malfunction
·ST PAUL·Product code FRN·September 22, 2022
CADD LEGACY PLUS PUMP
FDA Adverse Event
Malfunction
·ST PAUL·Product code FRN·September 8, 2022
CADD LEGACY PLUS PUMPS
FDA Adverse Event
Malfunction
·ST PAUL·Product code FRN·October 29, 2022
CADD LEGACY PLUS PUMPS
FDA Adverse Event
Malfunction
·ST PAUL·Product code FRN·October 24, 2022
STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100NX process to inactivate microorganisms on a board range of medical devices and surgical instruments.
FDA Enforcement
Class II
·Terminated·Advanced Sterilization Products·April 10, 2013