BEUDAMED
    242 results · 12ms · Sources: EU EUDAMED, US FDA

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    Version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS) released on July 11, 2016

    FDA Recall
    Terminated ·Roche Diabetes Care, Inc.·Product code NDC·September 14, 2016

    Version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS) released on July 11, 2016

    FDA Enforcement
    Class II ·Terminated·Roche Diabetes Care, Inc.·November 23, 2016

    Carton: Richard-Allan Scientific CYTO-STAIN; REF 7501R; Quantity: 1x1 Gallon; Size: 1 Gallon/3.8L; LOT 313833; 11/2016; Bottle: Richard-Allan Scientific CYTO-STAIN G; REF 7501G; 1 Gallon/3.8L; Thermo Scientific.

    FDA Recall
    Terminated ·Richard-Allan Scientific Company·Product code HZJ·February 19, 2015

    Carton: Richard-Allan Scientific CYTO-STAIN; REF 7501R; Quantity: 1x1 Gallon; Size: 1 Gallon/3.8L; LOT 313833; 11/2016; Bottle: Richard-Allan Scientific CYTO-STAIN G; REF 7501G; 1 Gallon/3.8L; Thermo Scientific.

    FDA Enforcement
    Class III ·Terminated·Richard-Allan Scientific Company·March 18, 2015

    iConnect Enterprise Archive (ICEA) software. iConnect Enterprise Archive is intended for use as a vendor neutral archive for storage and communications of medical images and data

    FDA Recall
    Terminated ·Merge Healthcare, Inc.·Product code LMB·April 4, 2016

    M/L Taper Hip Prosthesis (Item: 00-7711-012-20, Lot: 62937093

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code LPH·February 11, 2016

    Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD

    FDA Recall
    Terminated ·Clark Laboratories, Inc. (dba, Trinity Biotech USA)·Product code PCL·July 11, 2016

    OptraPol Polishing Discs, Rx ONLY: OptraPol Refill Cup /10: REF/Product ID 634459, OptraPol Refill Small Flame/10: REF/Product ID 634458, OptraPol Assortment: REF/Product ID 634464 --Device Listing # B106952. One step polishing system for all common dental composites and amalgam.

    FDA Recall
    Terminated ·Ivoclar Vivadent, Inc.·Product code EHJ·July 11, 2016

    VITROS Chemistry Products URIC Slides, REF/Product Code 194 3927 (300 slides per sales unit), Unique Device Identifier No. 10758750000340, Rx ONLY, IVD --- For in vitro diagnostic use only.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code KNK·August 11, 2016

    VITROS Chemistry Products LAC Slides, REF/Product Codes 843 3880 (300 slides per sales unit) and 815 0112 (90 slides per sales unit), Unique Device Identifier Nos. 10758750004911 and 10758750004454, Rx ONLY, IVD --- For in vitro diagnostic use only. VITROS Chemistry Products 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 KHP·August 11, 2016

    VITROS Chemistry Products TRIG Slides, REF/Product Codes 133 6544 (300 slides per sales unit) and 832 9930 (90 slides per sales unit), Unique Device Identifier Nos. 10758750008889 and 10758750004768, Rx ONLY, IVD --- For in vitro diagnostic use only. VITROS Chemistry Products TRIG Slides quantitatively measure triglyceride (TRIG) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code CDT·August 11, 2016

    Merge Cardio software using EchoIMS. The firm name on the label is Merge Healthcare, Hartland, WI.

    FDA Recall
    Terminated ·Merge Healthcare, Inc.·Product code LLZ·April 4, 2016

    DR Systems Unity PACS software, now known as Merge Unity PACS

    FDA Recall
    Terminated ·Merge Healthcare, Inc.·Product code LLZ·April 8, 2016

    Merge Cardio software.

    FDA Recall
    Terminated ·Merge Healthcare, Inc.·Product code LLZ·April 4, 2016

    Merge Eye Station Import Utility (ESIU). The firm name on the labeling is Merge Healthcare.

    FDA Recall
    Terminated ·Merge Healthcare, Inc.·Product code OUG·April 4, 2016

    VITROS Chemistry Products GLU Slides, REF/Product Code 170 7801 (300 slides per sales unit), Unique Device Identifier No. 10758750009572, Rx ONLY, IVD --- For in vitro diagnostic use only. VITROS Chemistry Products GLU Slides quantitatively measure glucose (GLU) concentration in serum, plasma, urine, and cerebrospinal fluid 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 CGA·August 11, 2016

    iConnect Enterprise Archive when used with RadSuite. The firm name on the label is Merge Healthcare.

    FDA Recall
    Terminated ·Merge Healthcare, Inc.·Product code LMB·April 4, 2016

    Safil QUI + UNDY 5/0 (1) 45CM DSMP13 Suture

    FDA Recall
    Terminated ·Aesculap Implant Systems LLC·Product code GAM·August 1, 2016

    25 gauge VersaVit 2.0 Vitrectomy Cutter, Product/Part Number 70935, packaged in a Tyvek/Mylar double pouch configuration.

    FDA Recall
    Terminated ·Synergetics Inc·Product code HQE·August 11, 2016

    Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI.

    FDA Recall
    Terminated ·Merge Healthcare, Inc.·Product code LLZ·April 4, 2016