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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Status: Terminated ×

    Zee Clear Vinyl Medical Examination Gloves, Powder Free, Large, Non-Sterile; 100 gloves per box, 10 boxes per case; Distributed by Zee Medical, Inc., Irvine, CA 92606, Made in China; Zee Part No.: 3062 Single Use, medical exam glove worn on the hand to provide a barrier against potentially infectious materials and other contaminants

    FDA Recall
    Terminated ·Cypress Medical Products LLC·Product code LYZ·November 15, 2011

    Zee Clear Vinyl Medical Examination Gloves, Powder Free, X-Large, Non-Sterile; 100 gloves per box, 10 boxes per case; Distributed by Zee Medical, Inc., Irvine, CA 92606, Made in China; Zee Part No.: 3063 Single Use, medical exam glove worn on the hand to provide a barrier against potentially infectious materials and other contaminants

    FDA Recall
    Terminated ·Cypress Medical Products LLC·Product code LYZ·November 15, 2011

    Kimberly-Clark, Synthetic Powder Free Vinyl Exam Gloves, Small, Medium and Large, 100 gloves per box, Non-Sterile, For Medical Use, Catalogue Numbers: 55031, 55032, and 55033. Distributed by Kimberly Clark LLC, Roswell, GA

    FDA Recall
    Terminated ·Kimberly-Clark Corporation·Product code LYZ·April 30, 2009

    Select Medical Products Vinyl Powder-Free Exam Gloves, Medium Model # 6370 and Large Model # 6371, 100 per box; 10 boxes per case. Usage: Patient Examination.

    FDA Recall
    Terminated ·Gulf South Medical Supply Inc·Product code LYZ·June 20, 2012

    Powder Free Vinyl Exam Gloves, Item Nos. 14-116, 14-118 Product Usage: Medical exam glove for use by professional healthcare workers and/or consumers.

    FDA Recall
    Terminated ·Cypress Medical Products LLC·Product code LYZ·July 2, 2018

    Zee Clear Vinyl Medical Examination Gloves, Powder Free, Medium, Non-Sterile; 100 gloves per box, 10 boxes per case; Distributed by Zee Medical, Inc., Irvine, CA 92606, Made in China; Zee Part No.: 3061 Single Use, medical exam glove worn on the hand to provide a barrier against potentially infectious materials and other contaminants

    FDA Recall
    Terminated ·Cypress Medical Products LLC·Product code LYZ·November 15, 2011

    McKesson Powder Free Vinyl Exam Gloves Catalog numbers 14-116, 14-118, 14-120, 14-136, 14-138 and 14-140

    FDA Recall
    Terminated ·CYPRESS MEDICAL PRODUCTS·Product code LYZ·October 12, 2016

    QuikClot TraumaPad, , sterile, soft, white, X-ray detectable hemostatic dressing Part Number 460 Manufactured by Z-Medica, LLC 4 Fairfield Boulevard, Wallingford, CT 06492 USA For use as a topical dressing for local management of bleeding wounds such as cuts, lacerations, and abrasions. It may also be used for temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, dermatological, etc.) and traumatic injuries

    FDA Enforcement
    Class II ·Terminated·Z-Medica, LLC·June 28, 2017

    BioPlant, a dental bone grafting material. BioPlant has been assigned the product code LYC (Bone Grafting Material, Synthetic) by the FDA and is classified as a Class II Medical Device. BioPlant is a Class II Medical Device. The Device Listing Number is 0007254. BioPlant is a synthetic, multipurpose bone-grafting material intended to be used in dental applications to maintain and restore the bony alveolar ridge in post-extraction tooth-root sockets or after oral surgery, ridge preservation, ridge augmentation, augmentations in the maxillary sinus, repair of periodontal defects and bone voids associated with dental implant placement.

    FDA Enforcement
    Class II ·Terminated·Kerr Corporation·November 28, 2012

    QuikClot TraumaPad, , sterile, soft, white, X-ray detectable hemostatic dressing Part Number 460 Manufactured by Z-Medica, LLC 4 Fairfield Boulevard, Wallingford, CT 06492 USA For use as a topical dressing for local management of bleeding wounds such as cuts, lacerations, and abrasions. It may also be used for temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, dermatological, etc.) and traumatic injuries

    FDA Recall
    Terminated ·Z-Medica, LLC·Product code FRO·May 17, 2017

    Mistique Infusion Catheter, K12-MIC13510, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code KRA·January 6, 2010

    Mistique Infusion Catheter, K12-MIC09005, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code KRA·January 6, 2010

    Mistique Infusion Catheter, K12-MIC09010, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code KRA·January 6, 2010

    Mistique Infusion Catheter, K12-MIC04505, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code KRA·January 6, 2010

    Mistique Infusion Catheter, K12-MIC04510, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code KRA·January 6, 2010

    Mistique Infusion Catheter, K12-MIC13505, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code KRA·January 6, 2010

    Mistique Infusion Catheter, MIC5-135-5-035, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code KRA·January 6, 2010

    Mistique Infusion Catheter, MIC5-135-5-038, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code KRA·January 6, 2010

    Mistique Infusion Catheter, MIC5-90-20-038, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code KRA·January 6, 2010

    Mistique Infusion Catheter, MIC5-45-5-035, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code KRA·January 6, 2010