BEUDAMED
    24 results · 11ms · Sources: EU EUDAMED, US FDA

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    14F x 20CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061423 Product Usage: An aid for introducing a hemodialysis catheter

    FDA Recall
    Terminated ·Medical Components, Inc dba MedComp·Product code LFJ·March 13, 2019

    14F x 30CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061425 Product Usage: An aid for introducing a hemodialysis catheter

    FDA Recall
    Terminated ·Medical Components, Inc dba MedComp·Product code LFJ·March 13, 2019

    14F x 24CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061424 Product Usage: An aid for introducing a hemodialysis catheter

    FDA Recall
    Terminated ·Medical Components, Inc dba MedComp·Product code LFJ·March 13, 2019

    14F SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061422

    FDA Recall
    Terminated ·Medical Components, Inc dba MedComp·Product code LFJ·March 13, 2019

    Hemodialysis Catheters and PICCs: Product identification: MCDLTSL24P (SF X 24CM LT HEMO-CATH), MC061422 (14FX15CM SLX DBL LMN ST CATH), MRCTP41017 (4F X 55CM SINGLE CT PICC), MRCTP52007 (5F DUAL PRO-PICC NURSING TRAY), MRCTP52010 (5F DUAL PRO-PICC MAX BARR TRAY), MR81013106MB (3FX60CM SGL TAPRLS VASCU-PICC). Intended uses: To attain long-term vascular access for hemodialysis and apheresis. The Medcomp SLX Silicone Double Lumen Catheter is designed for acute hemodialysis and apheresis. The Pro-PICC CT catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injection of contrast media, and allows for central venous pressure monitoring. The Peripherally Inserted Central Vein Access Catheters are designed for Long or Short- Term peripheral access to the central venous system for intravenous therapy and blood sampling, and allows for central venous pressure monitoring.

    FDA Recall
    Terminated ·Medical Components, Inc dba MedComp·Product code LFJ·January 21, 2015

    CHS Custom Convenience Kit- COBAN¿, LF (1"X5 YDS) Product Number:D5-14591

    FDA Enforcement
    Class II ·Terminated·Custom Healthcare Systems, Inc.·October 31, 2018

    Sterile Co-Flex LF2 3" - Product Usage: Single Use secondary wound dressing or compression wrap

    FDA Enforcement
    Class II ·Terminated·Andover Healthcare Inc.·October 30, 2019

    Sterile Co-Flex LF2 4" - Product Usage: Single Use secondary wound dressing or compression wrap

    FDA Enforcement
    Class II ·Terminated·Andover Healthcare Inc.·October 30, 2019

    CHS Custom Convenience Kit- COBAN, LF (1"X5 YDS) Product Number:D5-14591

    FDA Recall
    Terminated ·Custom Healthcare Systems, Inc.·Product code LRO·August 13, 2018

    Multi-Drug iCup Drug Screen Test Cup. Part Number DUE-1127-022-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

    FDA Recall
    Terminated ·Biosite Inc·Product code DKZ·April 27, 2009

    Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-1107-012-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

    FDA Recall
    Terminated ·Biosite Inc·Product code DKZ·April 27, 2009

    Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-197-014-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

    FDA Recall
    Terminated ·Biosite Inc·Product code DKZ·April 27, 2009

    Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUD-187-013-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

    FDA Recall
    Terminated ·Biosite Inc·Product code DKZ·April 27, 2009

    Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUE-187-071-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

    FDA Recall
    Terminated ·Biosite Inc·Product code DKZ·April 27, 2009

    Soft Face "No Bounce" Mallet Model/Catalog: BIO-1-1090

    FDA Recall
    Terminated ·Signal Medical Corporation·Product code GFJ·February 20, 2017

    VITROS Chemistry Products LAC Slides packaged as 300 slides/pack catalog number 8433880 and packaged as 90 slides/pack catalog number 8150112 VITROS LAC Slides quantitatively measure lactate (LAC) concentration in plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code CFJ·June 12, 2013

    Advia Chemistry Assay: Lactate

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CFJ·March 17, 2016

    smith&nephew PROFIX Mallet, 750 GRAMS, REF 71512452 - Product Usage: The PROFIX Mallet is a reusable surgical instrument used to tap instruments or implants during knee or hip surgery.

    FDA Recall
    Terminated ·Smith & Nephew, Inc.·Product code GFJ·November 11, 2019

    Lactate. Intended for use on COBAS INTEGRA 800 and 400 plus systems, cobas c111, Roche/Hitachi MODULAR systems, and cobas c systems for the quantitative determination of lactate concentration in plasm and cerebrospinal fluid.

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code CFJ·May 7, 2015

    Lactate Reagent (LACT 2 x 50), Catalog No. A95550 Intended for the quantitative determination of Lactate concentration in human plasma and cerebrospinal fluid (CSF).

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CFJ·April 3, 2017