BEUDAMED
    23 results · 11ms · Sources: EU EUDAMED, US FDA

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    Sorin Stockert Heater-Cooler System 3T, a) Item #: 16-02-81, 240 v/60 Hz; b) Item #: 16-02-82, 208 v/60 Hz; c) Item #: 16-02-85, 120 v/60 Hz

    FDA Enforcement
    Class II ·Terminated·LivaNova USA·May 30, 2018

    Sorin Stockert Heater-Cooler System 3T, a) Item #: 16-02-81, 240 v/60 Hz; b) Item #: 16-02-82, 208 v/60 Hz; c) Item #: 16-02-85, 120 v/60 Hz

    FDA Recall
    Terminated ·LivaNova USA·Product code DWC·April 20, 2018

    Karl Storz SE & Co. KG, C-MAC Video Laryngoscope MIL # 1, for the following REF numbers: 1. 8403xx series, which includes: 8403AX, AXC, BX, BXC, DXC, EXC, GXC, HX, HXK, HXP, KXC, MXC 2. 8401xx series, which includes: 8401AX, AXC, BX, BXC, DXC, GXC, HX, HXP, KXC. Product Usage: Video Laryngoscopes are used to visualize the airways and vocal cords during endotracheal intubation and for the inspection and examination of the upper respiratory tract. Video Laryngoscopes are designed for transient use in invasive procedures through a body orifice.

    FDA Enforcement
    Class II ·Terminated·Karl Storz Endoscopy·April 8, 2020

    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 Enforcement
    Class II ·Terminated·Ameditech Inc·October 7, 2020

    Karl Storz SE & Co. KG, C-MAC Video Laryngoscope MIL # 1, for the following REF numbers: 1. 8403xx series, which includes: 8403AX, AXC, BX, BXC, DXC, EXC, GXC, HX, HXK, HXP, KXC, MXC 2. 8401xx series, which includes: 8401AX, AXC, BX, BXC, DXC, GXC, HX, HXP, KXC. Product Usage: Video Laryngoscopes are used to visualize the airways and vocal cords during endotracheal intubation and for the inspection and examination of the upper respiratory tract. Video Laryngoscopes are designed for transient use in invasive procedures through a body orifice.

    FDA Recall
    Terminated ·Karl Storz Endoscopy·Product code EQN·December 6, 2019

    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

    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

    Bardex Lubricath 3-Way 75cc Continuous Irrigation Foley Catheter (Creevy), 22Fr. Rx (01267522)

    FDA Recall
    Terminated ·C.R. Bard, Inc.·Product code EZC·December 13, 2017

    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

    Bard Foley procedural trays packaged in breather bags. The product is packaged ten units in each shipper box, and are sold sterile for single use. Used to catheterize patients. The finished trays are sold in Tyvek breather bags.

    FDA Recall
    Terminated ·C.R. Bard, Inc., Urological Division·Product code EZC·June 29, 2012

    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

    Safeway Sterile Preserved Saline Solution 12oz, Product SKU#321130-700707. This product is supplied in 12 fl. oz. (355 mL) bottles for use in rinsing of soft (hydrophilic) contact lenses after heat (thermal) disinfection and rinsing of contact lenses following chemical disinfection.

    FDA Recall
    Terminated ·K C Pharmaceuticals Inc·Product code LYL·February 3, 2010

    Kroger Sterile Preserved Saline Solution 12oz, Product SKU#011110-385956. This product is supplied in 12 fl. oz. (355 mL) bottles for use in rinsing of soft (hydrophilic) contact lenses after heat (thermal) disinfection and rinsing of contact lenses following chemical disinfection.

    FDA Recall
    Terminated ·K C Pharmaceuticals Inc·Product code LYL·February 3, 2010

    Publix Sterile Preserved Saline Solution 12oz, Product SKU#041415-003767. This product is supplied in 12 fl. oz. (355 mL) bottles for use in rinsing of soft (hydrophilic) contact lenses after heat (thermal) disinfection and rinsing of contact lenses following chemical disinfection.

    FDA Recall
    Terminated ·K C Pharmaceuticals Inc·Product code LYL·February 3, 2010

    CVS Sterile Preserved Saline Solution 12oz, Product SKU#050428-253793. This product is supplied in 12 fl. oz. (355 mL) bottles for use in rinsing of soft (hydrophilic) contact lenses after heat (thermal) disinfection and rinsing of contact lenses following chemical disinfection.

    FDA Recall
    Terminated ·K C Pharmaceuticals Inc·Product code LYL·February 3, 2010