34 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762)
FDA 510(k)
FDA Class 2
·Neurology
SKINNER FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896084933·SKINNER FORCEPS TUNGSTEN CARBIDE SERRATED TIP
OsteoMed
FDA UDI
OSTEOMED LLC·00845694017855·MFx 2.4 Reconstruction Organizer Block
BSSO/LFI INTERDNTL OSTETOMY RE
FDA UDI
W.H. Holden, Inc.·D9282007230·
HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDROPHILIC AND NON-HYDROPHILIC)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DIMENSION ALDL CALIBRATOR, MODEL DC131
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 15, 2012
SPRINT FIDELIS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 15, 2012
ENTRUST AT
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWS·October 15, 2012
UNK
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·January 17, 2008
UNKNOWN
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·January 17, 2008
AUVON TENS & EMS DEVICE
FDA Adverse Event
Injury
·SHEN ZHEN AS TEC TECHNOLOGY CO LTD·Product code NUH·January 28, 2025
SOLETRA
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code MHY·May 9, 2011
CELL-DYN 1700 CS ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS DIVISION·Product code GKZ·October 20, 2008
VITROS 5600 INTEGRATED SYSTEM
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code MMI·August 11, 2011
MINICAP TRANSFER SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·July 1, 2013
ARCHITECT TSH
FDA Adverse Event
Other
·ABBOTT LABORATORIES·Product code JLW·November 30, 2007
SYNCHROMED EL
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·February 6, 2008
AUVON TENS UNIT
FDA Adverse Event
Injury
·SHEN ZHEN AS TEC TECHNOLOGY CO LTD·Product code NUH·December 19, 2024
OPTIFLOW FILTERED NASAL INTERFACE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·February 11, 2025