10 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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3M ActiV.A.C. Canister - 300ml with Gel (M8275058/5, M8275058/10)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
COMBOMAP PRESSURE AND FLOW SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
POD SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
M.U.S.T. PEDICLE SCREW SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PML·February 26, 2026
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·November 10, 2014
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 17, 2011
LD304 MATERNITY BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code HDD·July 22, 2013
M.U.S.T. PEDICLE SCREW SYSTEM
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code PML·November 13, 2025
MultiDim Eleva 708032 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Nederlands·May 9, 2018
MultiDiagnost Eleva with Flat Detector; x-ray system. Product Codes: 708034, 708037, 708038.
FDA Enforcement
Class II
·Terminated·Philips Electronics North America Corporation·August 10, 2016