BEUDAMED
    52 results · 13ms · Sources: EU EUDAMED, US FDA

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    Filters FDA Recall × Status: Terminated × Clear all

    Coloplast, Saline Filled Testicular Prosthesis, Sterile R, Manufacturer Coloplast A/S 3050 Denmark. Catalogue Number Description Part Number 450-1323 Extra Small 520600 450-1325 Small 520610 450-1327 Medium 520630 450-1329 Large 520650 The Coloplast Saline-Filled Testicular Prosthesis is intended for use when cosmetic testicular replacement is indicated i.e., in the case of agenesis or following the surgical removal of a testicle. The Butterfly Needle is used to fill the implant with saline.

    FDA Recall
    Terminated ·Coloplast Manufacturing US, LLC·Product code FAF·April 30, 2010

    CT Goldseal BrightSpeed 16 PWR TIO 2 YR

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code JAK·May 24, 2018

    Polyisoprene condomns Product Usage: The Durex Synthetic polyisoprene male condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted disease).

    FDA Recall
    Terminated ·Reckitt Benckiser LLC·Product code MOL·August 6, 2018

    Mar Cor Purification CWP Reverse Osmosis System. Models 101, 102, 104, and 106.

    FDA Recall
    Terminated ·Mar Cor Purification·Product code FIP·June 27, 2012

    Mar Cor Purification Millenium HX Portable Reverse Osmosis System. Model 3025975. Product Usage: Water Purification System is intended to be used as a dialysis accessory to produce water through reverse osmosis for use with hemodialysis equipment..

    FDA Recall
    Terminated ·Mar Cor Purification·Product code FIP·June 26, 2013

    Mar Cor Purification, Central Water Platform (CWP), 102, 104 and 106. Product Usage: The CWP is a Central reverse osmosis system with the intended use of producing water for dialysis of multiple patients.

    FDA Recall
    Terminated ·Mar Cor Purification·Product code FIP·April 24, 2014

    Tourni-Cot - Universal, UDI 00855364004085, Model Number TCU, Non-pneumatic Tourniquet - Product Usage: The device is intended to be used in surgery on fingers or toes to provide a blood-less field.

    FDA Recall
    Terminated ·Mar-Med Co·Product code GAX·December 28, 2020

    Arkon Anesthesia Delivery System, Model 99999. Product Usage: Continuous Ventilator The Arkon Anesthesia Delivery System is designed to provide emergency oxygen, vaporized agent delivery and manual ventilation in the event of a power failure scenario. Clinicians are able to use Emergency O2 and manually ventilate the patient, providing gas and agent. However, the anesthesiologist will not have access to mechanical ventilation or ventilator monitoring.

    FDA Recall
    Terminated ·Del Mar Reynolds Medical, Ltd.·Product code CBK·February 8, 2017

    Spacelabs Pediatric Flow Sensor Kit, PN: 376-0561-00. This kit is for Spacelabs Healthcare Blease 700/900 Series Ventilators. Designed specifically for the mechanical ventilation of adult and pediatric patients under general anesthesia.

    FDA Recall
    Terminated ·Del Mar Reynolds Medical, Ltd.·Product code CBK·March 5, 2015

    Spacelabs Healthcare Arkon Anesthesia Delivery System is intended for use in the hospital environment and operating room. Absorber Adapter Assembly Service Kit, part number: 050-9045-00. Absorber Adapter Assembly, part number: 650-1648-01. Arkon Absorber Canister Carrier, part number: 380-0916-01.

    FDA Recall
    Terminated ·Del Mar Reynolds Medical, Ltd.·Product code BSZ·April 14, 2017

    Juxta-Lite compression wrap Large Full Calf Short 28cm Length with Anklet Catalog 23025117

    FDA Recall
    Terminated ·Circaid Medical Products Inc·Product code MDR·April 20, 2010

    Organogenesis Apligraf, interactive wound and burn dressing, Organogenesis, Inc., Canton, Massachusetts 02021

    FDA Recall
    Terminated ·Organogenesis, Inc.·Product code MGR·December 26, 2007

    Juxta-Lite compression wrap XL Full Calf Long 33cm Length with Separate Small AFW Catalog 23226117

    FDA Recall
    Terminated ·Circaid Medical Products Inc·Product code MDR·April 20, 2010

    Juxta-Lite compression wrap XL Full Calf Short 28cm Length with Separate Medium AFW Catalog 23136117

    FDA Recall
    Terminated ·Circaid Medical Products Inc·Product code MDR·April 20, 2010

    Organogenesis, Inc., Apligraf (draftskin) packaging, Canton, MA 02021. Indicated for use with standard therapeutic compression for the treatment of non-infected partial and full-thickness skin ulcers and for the treatment of full-thickness neuropathic diabetic foot ulcers.

    FDA Recall
    Terminated ·Organogenesis, Inc.·Product code MGR·September 27, 2009

    Juxta-Lite compression wrap XL Long 33cm Length with Separate Medium AFW Catalog 23236017

    FDA Recall
    Terminated ·Circaid Medical Products Inc·Product code MDR·April 20, 2010

    Juxta-Lite compression wrap XL Full Calf Short 28cm Length with Anklet Catalog 23026117

    FDA Recall
    Terminated ·Circaid Medical Products Inc·Product code MDR·April 20, 2010

    Immulite 2000 H. pylori IgG Kit lot 118 (L2KHQ6, 600 test size kit)

    FDA Recall
    Terminated ·Diagnostic Products Corp·Product code LYR·July 31, 2003

    H. Pylori IgM ELISA 96 Well Kit, Catalog Number: HP015M The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only.

    FDA Recall
    Terminated ·Calbiotech Inc·Product code LYR·August 27, 2008

    H. Pylori IgA ELISA 96 Well Kit, Catalog Number: HP014A The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only.

    FDA Recall
    Terminated ·Calbiotech Inc·Product code LYR·August 27, 2008