18 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Vantage Total Ankle Flat Cut Talar Components
FDA 510(k)
FDA Class 2
·Orthopedic
Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012
L300 PLUS SYSTEM (RIGHT, LEFT), L300 PLUS SYSTEM UPGRADE KIT (RIGHT, LEFT)
FDA 510(k)
FDA Class 2
·Neurology
HEADWAY 17 MICROCATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
BD LUER-LOK
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·November 5, 2025
UPJ OCCLUSION BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code EZL·December 6, 2021
JETSTREAM XC-2.4 CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code MCW·February 10, 2015
STRYKER EPIC II
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·October 1, 2008
TOTAL ASR ACET IMP SIZE 60
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code KWA·June 21, 2013
SPRINT FIDELIS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·July 28, 2011
Sof-Flex Double Pigtail Ureteral Stent Set, Global Product No. G15076 G14906 G14840 G14865 G17128
FDA Enforcement
Class II
·Terminated·Cook Inc.·February 12, 2020
UPJ OCCLUSION BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code EYB·July 2, 2024
UPJ OCCLUSION BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code EZL·February 28, 2022
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
UPJ OCCLUSION BALLOON CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code EZL·July 8, 2022
UPJ OCCLUSION BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code EZL·January 15, 2021
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
Reagent Kits/ containing flow cells, components of NextSeq 550Dx Instrument: NextSeq 550Dx High Output Reagent Kit v2.5 (75 cycles) IVD, REF: 20028870/NextSeq 550Dx HO FC Cart v2.5, 75 Cycles, REF: 20031098; NextSeq 550Dx High Output Reagent Kit v2.5 (300 cycles) IVD, REF: 20028871/NextSeq 550Dx HO FC Cart v2.5, 300 Cycles, REF: 20026365; CN NextSeq 550Dx High Output Reagent Kit v2.5 (75 cycles) IVD, REF: 20064341/CN NEXTSEQ 550Dx HO FLOW CELL V2.5, REF: 20062316; CN NextSeq 550Dx High Output Reagent Kit v2.5 (300 cycles) IVD, REF: 20064344/CN NEXTSEQ 550Dx HO FLOW CELL V2.5, REF: 20062316; CN NextSeq 550Dx Mid Output Reagent Kit v2.5 (150 cycles) IVD, 20064345/CN NEXTSEQ 550Dx MO FLOW CELL V2.5, REF: 20062530; CN NextSeq 550Dx Mid Output Reagent Kit v2.5 (300 cycles) IVD, 20064346/CN NEXTSEQ 550Dx MO FLOW CELL V2.5, REF: 20062530; /FLOWCELL, FIT FLUIDICS TESTING, REF: 15050205
FDA Enforcement
Class II
·Ongoing·Illumina, Inc.·December 10, 2025