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

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    11-VI Incorporated Laser diode component Non-certified laser diode component used in laser sights for firearms

    FDA Enforcement
    Class II ·Terminated·Ii - Vi Incorporated·June 13, 2018

    Crimson Trace Corporation laser sights. The Finished Products are laser sighting systems for firearms, used for personal defense and target acquisition.

    FDA Enforcement
    Class II ·Terminated·Crimson Trace Corporation·May 2, 2018

    Crimson Trace Corporation laser sights. The Finished Products are laser sighting systems for firearms, used for personal defense and target acquisition.

    FDA Recall
    Terminated ·Crimson Trace Corporation·Product code REU·October 10, 2017

    ProScreen" Drugs of Abuse Test (AMT Item/ AMT Description): PSD-6MB/ "ProScreen" Drugs of Abuse Test (MET1000/OPI2000)+AMP+BZO+COC+THC", PSD-6MTDBO-300 /"ProScreen" Drugs of Abuse Test (COC/THC)+BZO+MTD+OPI300+OXY", PSCUP-5M-W/ ProScreen" Drugs of Abuse Cup AMP/COC/MET1000/OPI2000/THC), PSD-10MOB "ProScreen" Drugs of Abuse Test (COC/THC)+(MET1000/OPI2000)+(OXY/ MDMA)+AMP+BZO+BUP+MTD", PSD-5M / "ProScreen" Drugs of Abuse Test AMP/COC/MET1000/OPI2000/THC", PSCUPA-10OM / ProScreen" Drugs of Abuse Cup (COC/THC)+(MET1000/OPI2000)+(OXY/ MDMA) +(PCP/AMP)+BAR+BZO

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

    11-VI Incorporated Laser diode component Non-certified laser diode component used in laser sights for firearms

    FDA Recall
    Terminated ·Ii Vi Incorporated·Product code N/A·December 13, 2017

    Gyrus ACMI Tripolar Ultra Cutting Forceps: 10 mm X 32 cm w/rotation-Reference Number: 006689-903

    FDA Recall
    Terminated ·Gyrus ACMI Corporation·Product code KNS·February 19, 2007

    ProScreen" Drugs of Abuse Test (AMT Item/ AMT Description): PSD-6MB/ "ProScreen" Drugs of Abuse Test (MET1000/OPI2000)+AMP+BZO+COC+THC", PSD-6MTDBO-300 /"ProScreen" Drugs of Abuse Test (COC/THC)+BZO+MTD+OPI300+OXY", PSCUP-5M-W/ ProScreen" Drugs of Abuse Cup AMP/COC/MET1000/OPI2000/THC), PSD-10MOB "ProScreen" Drugs of Abuse Test (COC/THC)+(MET1000/OPI2000)+(OXY/ MDMA)+AMP+BZO+BUP+MTD", PSD-5M / "ProScreen" Drugs of Abuse Test AMP/COC/MET1000/OPI2000/THC", PSCUPA-10OM / ProScreen" Drugs of Abuse Cup (COC/THC)+(MET1000/OPI2000)+(OXY/ MDMA) +(PCP/AMP)+BAR+BZO

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

    LMA Esophageal Intubation Detector (EID), Catalog Number EID100 The device is used to assist verification of placement of the endotracheal tube or esophageal/tracheal double lumen tube. This device is to be used as an adjunct to assess intubation. Its purpose is not to eliminate clinical judgment

    FDA Enforcement
    Class II ·Terminated·LMA North America Inc·July 25, 2012

    LMA Esophageal Intubation Detector (EID), Catalog Number EID100 The device is used to assist verification of placement of the endotracheal tube or esophageal/tracheal double lumen tube. This device is to be used as an adjunct to assess intubation. Its purpose is not to eliminate clinical judgment

    FDA Recall
    Terminated ·LMA North America Inc·Product code BTR·May 23, 2012

    LMA- Unique Laryngeal Mask Airway Size 4, Catalog No. 12140, Lot FH041202 Size 4, Catalog No. 12150, Lot FJ021202

    FDA Recall
    Terminated ·LMA North America Inc·Product code CAE·June 18, 2003

    Micro Surgery Handpiece SGS, Model: SGS-E2S, Order Code: H266, Manufactured by: Nakanishi Inc The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible..

    FDA Recall
    Terminated ·Nakanishi Inc. 700 Shimohinata Kanuma Japan·Product code KMW·June 1, 2018

    Surgical Handpiece, Model: SGA-E Order Code: H083, Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible.

    FDA Recall
    Terminated ·Nakanishi Inc. 700 Shimohinata Kanuma Japan·Product code KMW·June 1, 2018

    LICOX Complete Brain IMC Probe Kit, Model IM3.ST C

    FDA Recall
    Terminated ·Integra Neuro Sciences·Product code GMW·January 21, 2005

    Micro Surgery Handpiece SGS, Model: SGS-ES, Order Code: H264, Manufactured by: Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible.

    FDA Recall
    Terminated ·Nakanishi Inc. 700 Shimohinata Kanuma Japan·Product code KMW·June 1, 2018

    Mattress Model 5185 and 5185XL. Manufactured by: Invacare Corp., 2101 East Lake Mary Blvd., Sanford, FL 32773. Mattress Model 5185 and 5185XL were packaged in the IVC Bed Models BED2-1633, BED4-1633, BED8-1633, BED9-1633, BED10-1633, BED12-1633, BED38LOW-1633, VCPKGIVC-1633 OR VCPKGIVC2-1633.

    FDA Recall
    Terminated ·Invacare Corporation·Product code FMW·August 29, 2007

    LICOX temperature probe, Model C8.B

    FDA Recall
    Terminated ·Integra Neuro Sciences·Product code GMW·January 21, 2005

    CareGuard Mattress Models CG10180 and CG10180A used with IVC and ValueCare Series of manual, semi-electric and electric beds. Mattresses can be identified by looking on the law label tag for the following information: Model # CG10180 or CG10180CA and a BLACK date code with the corresponding month and year of manufacture (i.e. September 2006. October 2006...August 2007). Manufactured by: Invacare Corp., 2101 East lake Mary Blvd. Sanford, FL 32773. Affected bed package model numbers: BED24IVC, BED25IVC, BED24CA or BED25CA,

    FDA Recall
    Terminated ·Invacare Corporation·Product code FMW·October 11, 2007

    Surgical Handpiece, Model: SGS-E, Order Code: H084, Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible.

    FDA Recall
    Terminated ·Nakanishi Inc. 700 Shimohinata Kanuma Japan·Product code KMW·June 1, 2018

    Surgical Handpiece, Model: SGS-E2G Order Code: H185, Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible.

    FDA Recall
    Terminated ·Nakanishi Inc. 700 Shimohinata Kanuma Japan·Product code KMW·June 1, 2018

    Micro Surgery Handpiece SGA, Model SGA-ES, Order Code:H263, Manufactured by: Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible.

    FDA Recall
    Terminated ·Nakanishi Inc. 700 Shimohinata Kanuma Japan·Product code KMW·June 1, 2018