25 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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I-DIXEL
FDA 510(k)
FDA Class 2
·Radiology
OPTOVENT RESPONS, OPTOVENT RENEE (OPTOVENT RESPONS WITHOUT PULSE OXIMETRY MODULE)
FDA 510(k)
FDA Class 2
·Anesthesiology
MEDIPLUS SINGLE USE GI MANOMETRY CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·February 11, 2025
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·March 3, 2025
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·February 23, 2025
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·November 27, 2024
880 HUMIDIFICATION SYSTEM
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·March 31, 2010
RESERVOIR 1.8ML MMT-326A
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·April 23, 2013
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Malfunction
·COCHLEAR LTD.·Product code MCM·May 2, 2011
OLYMPUS
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code KNW·July 1, 2008
880 HUMIDIFICATION SYSTEM
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD.·Product code BTT·February 15, 2010
RESPIRATORY HUMIDIFIER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·May 12, 2024
RESPIRATORY HUMIDIFIER
FDA Adverse Event
Injury
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·July 4, 2024
DIMENSION EXL WITH LM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS·Product code JJE·June 13, 2013
880 HUMIDIFICATION SYSTEM
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·April 15, 2010
DIMENSION EXL 200
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC·Product code JJE·July 23, 2013
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·December 6, 2023
PINNACLE SECTOR II CUP 60MM
FDA Adverse Event
Injury
·. DEPUY ORTHOPAEDIC INC, 1818910·Product code KWA·May 25, 2018
ACL Advance Instrument Analyzer
FDA Recall
Terminated
·Instrumentation Laboratory Co.·Product code JPA·March 4, 2004