47 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TROJAN LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CUSTOM PROCEDURE KIT
FDA UDI
MEDIVATORS INC.·40677964006508·CUSTOM PROCEDURE KIT
TeleVac2
FDA UDI
Conmed Corporation·20845854082468·TELEVAC2 HOSE AND CABLE KIT
PowerPICC Provena
FDA UDI
Bard Access Systems, Inc.·00801741140419·Catheter Placement Kit
EasySep™ Human Bone Marrow CD138 Positive Selection Kit
FDA UDI
Stemcell Technologies Canada Inc·07540207107483·EasySep Human Bone Marrow CD138 Positive Select...
SEALOUETTE FIBRIN SEALANT EXTENDED DROPLET APPLICATOR, MODEL TE-1
FDA 510(k)
FDA Class 2
·General Hospital
RGP MULTI-PURPOSE SOLUTION ID 100136
FDA 510(k)
FDA Class 2
·Ophthalmic
EasySep Human Bone Marrow CD138 Positive Selection Kit (100-0748)
FDA 510(k)
FDA Class 2
·Immunology
LEKSELL GAMMA KNIFE
FDA Adverse Event
Malfunction
·ELEKTA INSTRUMENT AB·Product code IWB·May 29, 2008
Leksell Gamma Knife C
FDA Recall
Terminated
·Elekta, Inc.·Product code IWB·August 1, 2006
LEKSELL GAMMA KNIFE
FDA Adverse Event
Malfunction
·ELEKTA INSTRUMENT AB·Product code IWB·May 29, 2008
LEKSELL GAMMA KNIFE
FDA Adverse Event
Malfunction
·ELEKTA INSTRUMENT AB·Product code IWB·May 29, 2008
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·March 12, 2013
EXTENSION, DUAL 4 CHANNEL 30CM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION DIV.·Product code LGW·February 17, 2011
BIPOL LEAD MODEL 300
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·February 21, 2008
LEKSELL GAMMA KNIFE
FDA Adverse Event
Malfunction
·ELEKTA INSTRUMENT AB·Product code IWB·May 29, 2008
Cleaning probe included as an accessory to aspirators that are sterile packed single use disposable accessories to the GE InstaTrak 3500 Plus x-ray system. Probes are packaged and shipped together with the following aspirators: Straight Aspirator - 1000370-NAV, 7 French Aspirator - 100936, Keane - Moses Extended Straight Aspirator - 1000748, 15 degree aspirator - 1003895, Fried 45 Degree Aspirator - 1000541, Kuhn 90 degree Aspirator - 1000543-NAV.
FDA Recall
Terminated
·GE OEC Medical Systems, Inc·Product code LLZ·May 18, 2007
LUMIRADX SARS-COV-2 AG TEST STRIP KIT
FDA Adverse Event
Malfunction
·LUMIRADX UK LTD.·Product code QKP·December 22, 2021
LUMIRADX SARS-COV-2 AG TEST STRIP KIT
FDA Adverse Event
Malfunction
·LUMIRADX UK LTD.·Product code QKP·December 22, 2021
LUMIRADX SARS-COV-2 AG TEST STRIP KIT
FDA Adverse Event
Malfunction
·LUMIRADX UK LTD.·Product code QKP·December 22, 2021