14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer
FDA 510(k)
FDA Class 2
·Cardiovascular
Integra® Miltex®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780506126·Integra® Miltex® House Needle, 6-1/4“, Malleabl...
Ophthalmic Retractor
FDA UDI
KATENA PRODUCTS, INC.·00841668101117·STEVENSON RETRACTOR 3X3 PRONGS
Midmark
FDA UDI
MIDMARK CORPORATION·00841709122262·Monitor Flex Arm Assembly used for Track Mounte...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702451313·Elvarex 2/Thigh High/Closed Toe, E-Version, Kne...
MODIFICATION TO PROFLU+ ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
UNKNOWN COOLSCULPTING SYSTEM
FDA Adverse Event
Injury
·ALLERGAN PLEASANTON·Product code OOK·December 20, 2021
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·May 8, 2025
VITEK MASS SPECTROMETER
FDA Adverse Event
Malfunction
·BIOMERIEUX, SA·Product code PEX·October 12, 2017
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 22, 2014
PAINSMART
FDA Adverse Event
Malfunction
·MOOG DEVICE GROUP·Product code FRN·May 28, 2013
10MM X 40MM UNCOVERED WALLFLEX BILLIARY RX STENT SYSTEM, MODEL M00570890
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code FGE·August 5, 2011
TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems·October 10, 2018