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

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    Filters FDA Recall × Status: Terminated × Clear all

    Adept-Med brand Glassman Viscera Retainer FISH Sterile, Item Numbers: 3204, 3202, 3203, 3202, 3201, 3200, 3206; Product is manufactured and distributed by Adept-Med International, Inc., 665 Pleasant Valley Rd., Diamond Springs, CA 95619

    FDA Recall
    Terminated ·Adept-Med International Inc·Product code GZC·August 17, 2004

    VasoNova Vascular Positioning System (VPS ) G4 Console Catalog number VPS-G4C Cardiovascular: The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters.

    FDA Recall
    Terminated ·VasoNova, Inc.·Product code OBJ·March 30, 2015

    Drug Screening Component: Uncut Sheets Part Number/ Description/ LOT Number 100163/ EDI OPI (300) Uncut Sheet-Card /187876, 100195/ EDI PPX Uncut Sheet-Card/ 187877, 160130/ EDI COC Uncut Sheet-Cup/ 188168, 160180/ EDI PCP Uncut Sheet-Cup/ 189027, 160140/ EDI THC Uncut Sheet Cup /189028, 160170/ EDI BZO Uncut Sheet-Cup/ 189081, 160120/ EDI MET1000 Uncut Sheet-Cup/ 189082, 160160/ EDI OPI2000 Uncut Sheet-Cup / 189123, 160130/ EDI COC Uncut Sheet-Cup/ 189124, 160160/ EDI OPI2000 Uncut Sheet-Cup/ 189166, 160163/ EDI OPI (300) Uncut Sheet-Cup/ 189191, 160110/ EDI AMP Uncut Sheet-Cup/ 189371, 160140/ EDI THC Uncut Sheet Cup/ 189372, 160123/ EDI MET(300) Uncut Sheet-Cup/ 189425, 160170/ EDI BZO Uncut Sheet-Cup/ 189426, 100163/ EDI OPI (300) Uncut Sheet-Card/ 189456, 160170/ EDI BZO Uncut Sheet-Cup/ 189565, 160180/ EDI PCP Uncut Sheet-Cup/ 189601, 160125/ EDI MET(500) Uncut Sheet-Cup/ 189748, 160130/ EDI COC Uncut Sheet-Cup/ 189786, 160160/ EDI OPI2000 Uncut Sheet-Cup / 189844, 160180/ EDI PCP Uncut Sheet-Cup/ 189937, 160172/ EDI BZO(200) Uncut Sheet-CUP/189956 Updated 09/03/2020: EDI Affected products -Catalog Numbers/ Lot Numbers 31105-3/ PI-01081 60503s-3ZC/ PH-10132 60600/ PH-11005

    FDA Recall
    Terminated ·Ameditech Inc·Product code DIO·August 18, 2020

    Biomet Microfixation outer packaging labeled in part:"REF: SP-2411***RUBBER BAND, LATEX FREE SMALL, HEAVY, 300/PACKAGE 4MM, (3/16" INNER DIAMETER) NON LATEX ELASTICS LOT 307850***DISTRIBUTED BY: BIOMET MICROFIXATION 1520 Tradeport Drive, Jacksonville, FL 32218 USA www.biometmicrofixation.com***." Inner Vendor/Manufacturer Label labeled in part:"H4 Elastics 4mm (3/16") Heavy 4 oz. REF 11-102-04***Manufactured for DENTSPLY GAC INTERNATIONAL DENTSPLY INTERNATIONAL, INC. Phone 631-419-1700 Fax 631-419-1599 355 Knickerbocker Avenue Bohemia NY 11716 USA***MediMark Europe BP2332 F-38033 Grenoble Cedex 2. France***LOT 82936-32 QTY:100 pk use by 2012-07 Made in USA ISSUED DATE 2009-04 GN***" Elastic bands used as elastomeric ties for ligation that facilitate treatment of fracture of the mandible and maxilla. They are commonly used with braces or arch bar wire.

    FDA Recall
    Terminated ·Biomet Microfixation, Inc.·Product code ECI·August 18, 2011

    Spanish 100-120V Cosmo Plus 8100, Respironics/Philips product. Used to provide spirometric, carbon dioxide and pulse oximetry monitoring.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code BZC·November 19, 2009

    REFURBISHED TIDALWAVE SP 710, REFURBISHED, Respironics/Philips product. Intended use of the monitors is to provide short term monitoring of carbon dioxide and oxygen saturation during anesthesia/recovery, in the intensive care unit (ICU), and in Emergency Medicine/transport of Respiratory Care.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code BZC·November 19, 2009

    SuperElastic Regular force NiTi lower or upper Natural arches. 0.14 size 10 or 100 count packages. Highland Metals Inc. San Jose, CA The devices are intended to provide force to the teeth to effect movement in order to alter their position.

    FDA Recall
    Terminated ·Highland Metals, Inc.·Product code DZC·December 13, 2013

    Innocor Cardiopulmonary Exercise and Lung Function Testing System Non-invasive diagnostic device that measures or calculates a number of hemodynamic and metabolic parameters.

    FDA Recall
    Terminated ·Innovision A/S Skovvaenget 2 Glamsbjerg Denmark·Product code BZC·May 13, 2016

    SuperElastic Regular force NiTi lower or upper Natural arches. 0.16 size 10 or 100 count packages. Highland Metals Inc. San Jose, CA The devices are intended to provide force to the teeth to effect movement in order to alter their position.

    FDA Recall
    Terminated ·Highland Metals, Inc.·Product code DZC·December 13, 2013

    Copper NiTi Preformed Archwires; Copper NiTi 40 BAF .016X.022 LO Pk10, Part No. 211-0952. Intended to provide tooth movement.

    FDA Recall
    Terminated ·Ormco/Sybronendo·Product code DZC·November 4, 2015

    TMA Archwires, Part Number 211-1402, Lot Number 10K291, Product Description and Intended Use: The intended use of this device is an archwire during orthodontic treatment.

    FDA Recall
    Terminated ·Ormco Corporation·Product code DZC·March 15, 2011

    Resp Profile Monitor, 8100 Cosmo+, Respironics/Philips product. Used to provide spirometric, carbon dioxide and pulse oximetry monitoring.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code BZC·November 19, 2009