12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PORT-X IV
FDA 510(k)
FDA Class 2
·Dental
Orbit Depressor
FDA UDI
KATENA PRODUCTS, INC.·00841668100899·SCHEPENS SCLERAL DEPRESSOR MEDIUM
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306821103·Dilator forceps .5mm
Ophthalmic Ring
FDA UDI
KATENA PRODUCTS, INC.·00841668100820·FLIERINGA FIXATION RING 21MM
n/a
FDA UDI
Ortho Development Corporation·00822409108091·Cement Only Broach Size 10
PRONTO LOW PROFILE (LP) EXTRACTION CATHETER, MODEL 5010
FDA 510(k)
FDA Class 2
·Cardiovascular
MULTI-ANALYTE DETECTION SYSTEMS
FDA 510(k)
FDA Class 2
·Immunology
HUDSON NEBULIZER ADAPTOR 028, STERILE, SHELFPAK
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code CCQ·October 10, 2014
DPM CENTRAL STATION / TRANSMITTER
FDA Adverse Event
Malfunction
·MINDRAY DS USA, INC·Product code MHX·May 21, 2013
ECHELON*FLEX45 ARTICULATING
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 22, 2011
Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014
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