80 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Affinity NTTM Oxygenator (Model 511), Affinity® NT Hollow Fiber Oxygenator with Plasma Resistant Fiber (PRF) with TrilliumTM Biosurface (Model 511T), Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber (Model 541), Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber (Model 541-R), Affinity NT® Integrated CVR/Membrane Oxygenator with Trillium® Biosurface (Model 541T), Affinity NT® Integrated CVR/Membrane Oxygenator with Trillium® Biosurfac
FDA 510(k)
FDA Class 2
·Cardiovascular
KAIFENG/CRYSTAL, KAILI, KAIJING, KAIYUE, MAIST AND KAITONG/ROYAL SYNTHETIC POLYMER TEETH
FDA 510(k)
FDA Class 2
·Dental
CLEANER ROTATIONAL THROMBECTOMY SYSTEM (9 MM X 65 CM) AND (9 MM X 120 CM)
FDA 510(k)
FDA Class 2
·Cardiovascular
ARSENAL PETITE LAPIDUS PLATE, R
FDA Adverse Event
Injury
·TRILLIANT SURGICAL·Product code HRS·April 3, 2020
CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·February 6, 2015
METS MODULAR DISTAL FEMUR IMPLANT
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·December 24, 2014
CUSTOM DISTAL FEMUR IMPLANT
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·December 24, 2014
CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT
FDA Adverse Event
Injury
·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·March 20, 2015
CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·March 13, 2015
CUSTOM DISTAL FEMUR IMPLANT
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·December 23, 2014
CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT
FDA Adverse Event
Injury
·STANMORE IMPLANTS WORLDWIDE LTD·Product code KRO·May 15, 2015
STABLE BASE
FDA Adverse Event
Injury
·LEONHARD LANG GMBH·Product code DRX·November 17, 2020
CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·December 19, 2014
CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT
FDA Adverse Event
Injury
·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·March 20, 2015
CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT
FDA Adverse Event
Injury
·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·April 16, 2015
CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·December 19, 2014
STABLE BASE
FDA Adverse Event
Injury
·LEONHARD LANG GMBH·Product code DRX·November 25, 2020
SJM BIOCOR SUPRA STENTED VALVE W/ FLEXFIT SYSTEM
FDA Adverse Event
Death
·ST JUDE MEDICAL BRASIL LTDA.·Product code LWR·June 21, 2013
RESTORE RECHARGEABLE NEUROSTIMULATOR
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·July 19, 2011
MITEK EXPRESSEW III NEEDLE
FDA Adverse Event
Malfunction
·DEPUY MITEK·Product code LXH·October 21, 2014