105 results
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18ms
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Sources: EU EUDAMED, US FDA
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TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, Atrial J, 60 degree Curve, and Right Heart. TB is packaged for sterile single use in a double tray. The lead is placed in a PETG inner tray that is sealed with a Tyvek inner lid. The sealed inner tray is placed in an outer PETG tray. The outer tray is sealed with an outer Tyvek lid. An inner label is placed on the outer Tyvek lid. The sealed trays are placed in a labeled white shelf box with on Instruction for use. Packed on lead per outer white shelf box.
FDA Enforcement
Class I
·Terminated·Oscor, Inc.·November 14, 2018
Intraocular Lens (IOL), Part No. EC-3 PAL, Diopter: 17.5, 18.0, 18.5, 19.0, 19.5, 21.5, 23.5, 9.0, 22.5, 23.0, 21.0, 24.0. The device is indicated for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed. Aaren Scientifics EC-3 IOLs are intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by phacoemulsification.
FDA Enforcement
Class II
·Terminated·Aaren Scientific, Incorporated·April 1, 2015
Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1004
FDA Enforcement
Class II
·Terminated·Kelyniam Global, Inc.·May 23, 2018
NICO Myriad Handpiece Product Number/Product Name: NN-8000 15x10 MHP; NN-8001 15x 13 MHP; NN-8002 15x 25 MHP - MINOP; NN-8003 13x10 MHP; NN-8004 13x13 MHP; NN-8005 15x25 MHP GAAB; NN-8006 11X10 MHP; NN-8007 11x13 MHP; NN-8008 19x28 MHP OI; NN-8010 17x31.5 MHP DECQ; NN-8015 NICO Fluid System (NFS); NN-8017 11x13 MHP/PB; NN-8018 13X13 MHP/PB; NN-8019 19x28 MHP Little LOTTA; NN-8020 19x21.5 MHP PaediScope; NN-8021 15x26.5 MHP LOTTA; NN-8500 15x10 MHP; NN-8501 15x13 MHP; NN-8502 15x25 MINOP MHP; NN-8503 13x10 MHP; NN-8504 13x13 MHP; NN-8505 15x25 GAAB MHP; NN-8506 11X10 MHP; NN-8507 11x13 MHP; NN-8508 19x28 OI MHP; NN-8510 17x31.5 DECQ MHP; NN-8517 13X13 MHP/PB; NN-8518 11x13 MHP/PB; NN-8519 19x28 Little LOTTA MHP; NN-8520 19x21.5 PaediScope MHP; NN-8521 15X26.5 LOTTA MHP;
FDA Enforcement
Class II
·Ongoing·Stryker Corporation·December 3, 2025
Maquet Getinge- (1) Material: 701067350R01 BEQ-TOP 5208 ECC Small-Cardiac (2) material: 701067350R02 BEQ-TOP 5208 ECC Small-Cardiac
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·June 5, 2019
Maquet Getinge- (1)Material: 701065765R01 BO-TOP 36504 Adult ECC Pack (2)Material: 701065765R02 BO-TOP 36504 Adult ECC Pack
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·June 5, 2019
Maquet Getinge- (1) Material: 701055490R01 BEQ-TOP 15801 ¿ inch ECC Pack (2) Material :701055490R02 BEQ-TOP 15801 1/4 in ECC Pack
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·June 5, 2019
SMR Shoulder/Spalla Trial Heads ECC .4 mm Adaptor, REF 9013.30.021; SMR Shoulder/Spalla Trial Heads ECC .8 mm Adaptor, REF 9013.30.031; for use in shoulder implant surgery.
FDA Enforcement
Class II
·Terminated·Limacorporate S.p.A·September 9, 2015
BEQ-TOP 24202 ADULT ECC, Catalog No. 701054295
FDA Enforcement
Class II
·Terminated·Datascope Corporation·May 16, 2018
Adult ECC Pack BEQ-TOP 22300, Catalog No. 701049504
FDA Enforcement
Class II
·Terminated·Datascope Corporation·May 16, 2018
Maquet Getinge-BEQ-TOP 44701 PEDIATRIC ECC Material: 701064825
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·June 5, 2019
Maquet Getinge-BEQ-T 8805 ECC PACK Material: 701053361
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·June 5, 2019
Maquet Getinge-BEQ-TOP 31000 PEDIATRIC ECC Material:701052843
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·June 5, 2019
Maquet Getinge-BEQ-TOP 21506 ECC PACK Material:701064505
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·June 5, 2019
Maquet Getinge-BEQ-TOP 26402 ECC PACK Material: 701062310
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·June 5, 2019
Maquet Getinge-BEQ-TOP 5502 ECC Pack Material: 701051791
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·June 5, 2019
Maquet Getinge-BEQ-TOP 24500 ADULT ECC Material: 701050253
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·June 5, 2019
Maquet Getinge-BEQ-TOP 24202 ADULT ECC Material:701054295
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·June 5, 2019
Maquet Getinge- BEQ-T 39700 ECC Pack Material:701062473R01
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·June 5, 2019
Maquet Getinge-BEQ-TOP 24202 ADULT ECC Material: 701054295R01
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·June 5, 2019