BEUDAMED
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    The GMD UNIVERSAL URINARY INCONTINENCE SLING (Code 1010) is supplied sterile and is intended for single patient use only. The GMD Universal Sling is a sterile, single use device for the treatment of female stress urinary incontinence. It is comprised of a polypropylene sheath with a disposable universal low density polyethylene sleeve at each end of attachment of the sling to GMD's single use or reusable trocars. The universal sleeve has three trocar insertion points, the distal and proximal trocar insertion points are for inside-out, bottom-up approaches and a sleeve end trocar insertion point is for outside-in, top-down approaches. The design allows the physician to utilize the device for placement of a polypropylene mesh at the urethra or bladder neck.

    FDA Recall
    Terminated ·Generic Medical Devices·Product code FTL·February 14, 2011

    GMD UNIVERSAL URINARY INCONTINENCE SLING, Rx ONLY Product Code 1020-18. Intended for use in women as a suburethral sling for the treatment of stress urinary incontinence resulting from either urethral hypermobility and/or intrinsic sphincter deficiency.

    FDA Recall
    Terminated ·Generic Medical Devices·Product code FTL·June 18, 2009

    CRYPTOCOCCAL ANTIGEN LATERAL FLOW ASSAY, IMMY, Lateral Flow Assay for the Detection of Cryptococcal Antigen in serum and CSF, REF CR2003, IVD, UDI: (01)00816387020919

    FDA Recall
    Terminated ·Immuno-Mycologics, Inc·Product code GMD·January 3, 2022

    Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Model # CR2003 Product Usage: The CrAg Lateral Flow Assay is an immunochromatographic test system for the qualitative or semi-quantitative detection of the capsular polysaccharide antigens of Cryptococcus species complex (Cryptococcus neoformans and Cryptococcus gattii) in serum and cerebral spinal fluid (CSF). The CrAg Lateral Flow Assay is a prescription-use laboratory assay which can aid in the diagnosis of cryptococcosis.

    FDA Recall
    Terminated ·Immuno-Mycologics, Inc·Product code GMD·March 30, 2018

    Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003

    FDA Recall
    Terminated ·Immuno-Mycologics, Inc·Product code GMD·December 27, 2016

    IMCO brand Conforming Stretch Gauze Bandages, 4 x 4.1 Yds/10 cm x 3,7 cm, Reorder No. 704-IMC, Bar code 6 86864 04351 5, 96 per case (8 boxes x 12 sterile bandages), Single Use To cover and protect the primary dressing that is in contact with wounds from further injuries, contamination and infection. To be used in health care facilities

    FDA Enforcement
    Class II ·Terminated·Amd Ritmed·April 6, 2016

    AMD-RITMED brand Conforming Stretch Gauze Bandages, Sterile, 6 in x 4/1 yds./15 cm x 3.7 cm, Reorder Number/Code D606, Bar code 6 86864 04230 3, Made in China -- Manufactured for & distributed by: AMD-RITMED INC. Montreal Quebec H8T 3J8 -- US Distribution: AMD-RITMED INC. Tonawanda, NY 14150 -- Type of packaging: 1 roll/pouch, 12 pouches/inner box, 4 inner box/case, 48 rolls per case. Conforming bandages used to cover and protect wounds from further injuries and contamination. This type of product fits all parts of the body without restrictive movement. To be used in health care facilities.

    FDA Recall
    Terminated ·Amd-Ritmed, Inc.·Product code FQM·March 30, 2016

    MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 2 MASKS, Item Code 2040

    FDA Recall
    Terminated ·AMD Medicom Inc.·Product code FXX·October 11, 2019

    Harleco May and Grunwald's Stain; 0.17% w/v; Methanol Solution UN1230; EMD Chemicals Inc. An Affilifate of Merck KGaA Damstadt, Germany; 480 South Democrat Road; Gibbstown, NJ 08027; 1 liter and 4 liter poly bottles

    FDA Recall
    Terminated ·EMD Chemicals Inc·Product code KQC·July 30, 2007

    Picasso/Picasso Lite lasers Intended use: Dentistry.

    FDA Recall
    Terminated ·AMD Lasers, LLC·Product code GEX·April 15, 2010

    Harleco Giemsa Stain 25 gram glass bottle, Item #228-12 Manufactured for EMD Chemicals Inc., Gibbstown, NJ 08027 1-800-222-0342 Made in India. The product is a Class I, IVD dye and chemical stain for use in Hematology.

    FDA Recall
    Terminated ·EMD Chemicals Inc.·Product code KQC·April 4, 2011

    Anaerotest for microbiology Specification: Performance Test Anerobic: white within 4-6 hours; aerobic: blue with 20 minutes Merck KgaA 64271 Darmstadt, Germany 1.19034.0002 17.08.06 1 unit UPC 4 022536 667928

    FDA Recall
    Terminated ·EMD Chemicals Inc·Product code J·August 17, 2006

    Ethanol Standard, 1.5mg Ethanol in 1 mL. Product size configuration: 1 mL glass ampule shipped 10 ampules per case.

    FDA Recall
    Terminated ·EMD Chemicals Inc·Product code LCH·December 13, 2002

    EMD Chemicals, Harleco Brand Ethanol Standard, 1.0 mg/ml; 1.0 mg Ethanol in 1 ml, 10 ampules; Item number 68991/95; in vitro diagnostic.

    FDA Recall
    Terminated ·EMD Chemicals Inc·Product code DNN·March 27, 2008

    Histochemical PAS (Periodic Acid Schiff) Reaction Set' Class I, IVD; Set of 4 bottles including Schiff Reagent 225 mL, Light Green SF Yellowish Stain 225 mL, Sodium Carbonate Solution 225 mL and Periodic Acid Solution 225 mL' EMD Chemicals, Inc. 480 S. Democrat Road, Gibbstown, NJ 08027 Each kit provides reagents sufficient for a maximum of 100 tests.

    FDA Recall
    Terminated ·EMD Chemicals Inc·Product code HZT·June 2, 2008

    Ethanol Standard, 0.5mg Ethanol in 1 mL. Product size configuration: 1 mL glass ampule shipped 10 ampules per case. Item Number 68988/95

    FDA Recall
    Terminated ·EMD Chemicals Inc·Product code LCH·December 13, 2002

    Anaerotest;Microbiology , 50 test strips 1.15112 Store dry and tightly closed. Store at + 15 C to +25C Merck IVD 64271 Darmstadt, Germany

    FDA Recall
    Terminated ·EMD Chemicals Inc·Product code J·August 17, 2006

    Histochemical PAS (Periodic Acid Schiff) Reaction Set. in vitro diagnostic. Product size configuration: Set of 4 bottles including Schiff Reagent 225mL, Light Green SF Yellowish Stain 225mL, Sodium Carbonate Solution 225mL, and Periodic Acid Solution 225mL. Each kit provides reagents sufficient for a maximum of 100 tests.

    FDA Recall
    Terminated ·EMD Chemicals Inc·Product code KKS·July 25, 2006

    MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 3 MASKS, Item Code 2042

    FDA Recall
    Terminated ·AMD Medicom Inc.·Product code FXX·October 11, 2019

    Papanicolaou Stain EA-50. Product size configurations: 1L, 4L, and 10L. Item Nos. 7062X/75, 7062X/85, and 7062X/86.

    FDA Recall
    Terminated ·EMD Chemicals Inc·Product code HZJ·December 13, 2002