14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Jet Power Injectable PICC
FDA 510(k)
FDA Class 2
·General Hospital
Quick Release Impactor Grip
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215082000·
BYTE DAY ALIGNERS
FDA Adverse Event
Malfunction
·STRAIGHT SMILE, LLC·Product code NXC·October 31, 2024
PARKER FLEX- TIP ORAL/NASA INTUBATION TUBE
FDA 510(k)
FDA Class 2
·Anesthesiology
NIHON KOHDEN EEG-1200A SERIES NEUROFAX, MODEL EEG-1200A
FDA 510(k)
FDA Class 2
·Neurology
BD¿ BLUNT FILTER NEEDLE WITH BLUNT FILL TIP
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code GAA·March 21, 2018
RD SET YI
FDA Adverse Event
Malfunction
·MASIMO - 52 DISCOVERY·Product code DQA·March 29, 2021
RD SET DCI
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code DQA·February 10, 2023
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·July 27, 2011
36MM COCR MODULAR HEAD +9MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·June 20, 2013
DISCOVISC
FDA Adverse Event
Injury
·ALCON-BELGIUM / S.A. ALCON-COUVREUR N.V.·Product code LZP·September 26, 2008
RD SET
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code DQA·December 31, 2025
RD SET
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code DQA·December 31, 2025
ARTIS icono biplane -Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 11327600
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·August 16, 2023