9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CONMED SELECT ONE LAPAROSCOPY ELECTRODE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NA
FDA UDI
DEPUY INTERNATIONAL LTD·10603295234005·9/10 36MM MOM TRIAL HD -3
PHO. TRAX MODEL 4000 WHOLE BODY SCAN.
FDA 510(k)
FDA Class 2
·Radiology
BRAINPRO, BRAINPRO ACCESS
FDA 510(k)
FDA Class 2
·Neurology
AZO
FDA Adverse Event
Other
·SIEMENS DIAGNOSTICS, INC.·Product code CEN·July 12, 2012
TRANSSEPTAL NEEDLE, BRK 1, 71CM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC. (AF-MINNETONKA)·Product code DRC·February 11, 2013
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·December 17, 2010
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·July 28, 2014
Sternal Valve Retractors With Atrial and Aortic Rakes; Models SRCL-1, SRCL-AR, SRLP-1, SRLP-AR, ATR-1, ATR-AR, CSR-1 and CSR-AR. For use in cardiac surgery.
FDA Enforcement
Class II
·Ongoing·Genesee BioMedical, Inc.·June 6, 2018