19 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ID-510 iRestore Elite
FDA 510(k)
FDA Class 2
·Physical Medicine
Peripheral Catheter Insertion Kit
FDA UDI
Bard Access Systems, Inc.·00801741110696·DOT PFlex, 22G 8cm Full w/o GIVa
36M - Class B 21 Kent - Metal
FDA UDI
Certified Safety Manufacturing, Inc.·00766588620817·36M - Class B 21 Kent - Metal
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112663·BARRON CORNEAL PUNCH 8.75MM
D & R PRODUCTS CO., INC.
FDA registration
D & R PRODUCTS CO., INC.·1 product·🇺🇸 United States
SMARTSITE¿ VENTED VIAL ACCESS DEVICE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FPA·January 28, 2023
BD SMARTSITE¿ VENTED VIAL ADAPTOR
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FPA·February 23, 2023
IQ FLEX M
FDA Adverse Event
Malfunction
·FIRST SOURCE INC.·Product code IZL·May 29, 2024
NUVASIVE LONG LATERAL SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Biodegradable DriTek Powder Free Nitrile Examination Glove, Low Dermatitis Potential Claim, Blue
FDA 510(k)
FDA Class 1
·General Hospital
1222081-2006-00017
FDA Adverse Event
Product code HTT·March 28, 2006
1222081-2007-00021
FDA Adverse Event
Other
·Product code HTT·July 27, 2007
1222081-2008-00018
FDA Adverse Event
Other
·Product code HTT·August 9, 2008
1222081-2008-00006
FDA Adverse Event
Other
·Product code HTT·March 21, 2008
1222081-2008-00005
FDA Adverse Event
Other
·Product code ---·March 7, 2008
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·November 3, 2014
ONE TOUCH ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·November 4, 2008
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 24, 2011
Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018