BEUDAMED
    109 results · 9ms · Sources: EU EUDAMED, US FDA

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    Filters FDA Enforcement × Classification: Class Ii × Clear all

    Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle.

    FDA Enforcement
    Class II ·Completed·Teleflex Medical·October 25, 2017

    Drug Screening Component: Uncut Sheets Part Number/ Description/ LOT Number 100163/ EDI OPI (300) Uncut Sheet-Card /187876, 100195/ EDI PPX Uncut Sheet-Card/ 187877, 160130/ EDI COC Uncut Sheet-Cup/ 188168, 160180/ EDI PCP Uncut Sheet-Cup/ 189027, 160140/ EDI THC Uncut Sheet Cup /189028, 160170/ EDI BZO Uncut Sheet-Cup/ 189081, 160120/ EDI MET1000 Uncut Sheet-Cup/ 189082, 160160/ EDI OPI2000 Uncut Sheet-Cup / 189123, 160130/ EDI COC Uncut Sheet-Cup/ 189124, 160160/ EDI OPI2000 Uncut Sheet-Cup/ 189166, 160163/ EDI OPI (300) Uncut Sheet-Cup/ 189191, 160110/ EDI AMP Uncut Sheet-Cup/ 189371, 160140/ EDI THC Uncut Sheet Cup/ 189372, 160123/ EDI MET(300) Uncut Sheet-Cup/ 189425, 160170/ EDI BZO Uncut Sheet-Cup/ 189426, 100163/ EDI OPI (300) Uncut Sheet-Card/ 189456, 160170/ EDI BZO Uncut Sheet-Cup/ 189565, 160180/ EDI PCP Uncut Sheet-Cup/ 189601, 160125/ EDI MET(500) Uncut Sheet-Cup/ 189748, 160130/ EDI COC Uncut Sheet-Cup/ 189786, 160160/ EDI OPI2000 Uncut Sheet-Cup / 189844, 160180/ EDI PCP Uncut Sheet-Cup/ 189937, 160172/ EDI BZO(200) Uncut Sheet-CUP/189956 Updated 09/03/2020: EDI Affected products -Catalog Numbers/ Lot Numbers 31105-3/ PI-01081 60503s-3ZC/ PH-10132 60600/ PH-11005

    FDA Enforcement
    Class II ·Terminated·Ameditech Inc·October 7, 2020

    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

    Endoscopic Cleaning Brush, single use, sold in kits and labeled as the following: a. Item Number DYK1002DCB, BRUSH, CLEANING, DOUBLE ENDED, W/ HANDLE - 300 EA/CS, 50EA/BX, 6BX/CS; b. Item Number DYK1002DBDE, BRUSH, CLEANING, DBL, DIF ENDS - 500 EA/CS, 50 EA/BX, 10 BX/CS; c. Item Number DYK1002DBSE, BRUSH, CLEANING, DBL, SAME END - 500 EA/CS, 50 EA/BX, 10 BX/CS; d. Item Number DYK1002SBC, BRUSH, CLEANING, SINGLE END - 500 EA/CS, 50 EA/BX, 10 BX/CS

    FDA Enforcement
    Class II ·Terminated·Medline Industries Inc·September 26, 2018

    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

    Maquet Getinge-BEQ-T 39700 ECC PACK Material:701062473

    FDA Enforcement
    Class II ·Terminated·Maquet Cardiovascular, LLC·June 5, 2019