BEUDAMED
    211 results · 21ms · 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

    Skytron Infinity Series surgical light, 4 bulbs in 1 - 22' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF54, IF54EL, IF54LH and IF54S.

    FDA Recall
    Terminated ·Skytron, Div. The KMW Group, Inc·Product code FTD·January 8, 2007

    Skytron Infinity series (also called Astro series) minor surgery light, 3 bulbs in 1 - 19' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Japan; Models IN19, IN19EL, IN19LH and IN19S.

    FDA Recall
    Terminated ·Skytron, Div. The KMW Group, Inc·Product code FTD·January 8, 2007

    Ergon III Series Skyboom Monitor Bracket. Part # 3FCM1 Flatscreen Bracket, single monitor mount, 27inch max. screen size

    FDA Recall
    Terminated ·Skytron, Div. The KMW Group, Inc·Product code FQO·March 28, 2016

    Skytron Infinity Series surgical light with triple lightheads, 4 bulbs in each of 3 - 22' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF545454 and IF545454EL.

    FDA Recall
    Terminated ·Skytron, Div. The KMW Group, Inc·Product code FTD·January 8, 2007

    Ergon 2 Articulating Equipment Boom Monitor Brackets mounting point for display interfaces utilized in clinical applications for viewing purposes and to provide an articulating point of movement on the ceiling mounted radial arm suspension system of the Ergon 2 equipment pendant / booms

    FDA Recall
    Terminated ·Skytron, Div. The KMW Group, Inc·Product code FQO·December 2, 2015

    Skytron Integrity 270 Steam Sterilizer and Skytron Integrity 270VP Steam Product Usage: The SKYTRON Integrity 270 Steam Sterilizer for use in health care facilities. The Integrity Sterilizer incorporates high-pressure steam to sterilize nonporous or porous items and materials used in the health care industry

    FDA Recall
    Terminated ·Skytron, Div. The KMW Group, Inc·Product code FLE·April 18, 2019

    Skytron General Purpose Surgical Table; Model 6600, Dist. by Skytron, Grand Rapids, MI.

    FDA Recall
    Terminated ·Skytron, Div. The KMW Group, Inc·Product code FQO·August 4, 2005

    Skytron Infinity Series surgical light with dual lightheads, 8 bulbs in 1 - 30' diameter lighthead and 5 bulbs in 1 - 22' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IN3022EL and IF3022EL. (note only the 22'' lighthead is affected).

    FDA Recall
    Terminated ·Skytron, Div. The KMW Group, Inc·Product code FTD·January 8, 2007

    Skytron Infinity Series surgical light, 5 bulbs in 1 - 22' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF22, IF22B, IF22LH, IF22LHH-B, IF22M-S, IN22, IN22EL, IN22LH and IF22(EL).

    FDA Recall
    Terminated ·Skytron, Div. The KMW Group, Inc·Product code FTD·January 8, 2007

    Skytron Infinity Series surgical light with dual lightheads, 5 bulbs in 1 - 22' lighthead and 8 bulbs in 1 - 30' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Model IF3022B. (note only the 22'' lighthead is affected.)

    FDA Recall
    Terminated ·Skytron, Div. The KMW Group, Inc·Product code FTD·January 8, 2007

    Skytron Infinity Series surgical light with dual lightheads, 5 bulbs in each of 2 - 22' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF2222, IF2222-B, IF2222B/PT, IF2222EL and IN2222EL.

    FDA Recall
    Terminated ·Skytron, Div. The KMW Group, Inc·Product code FTD·January 8, 2007

    Skytron Infinity Series surgical light with dual lightheads, 4 bulbs in each of 2 - 22' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF5454 and IF5454EL.

    FDA Recall
    Terminated ·Skytron, Div. The KMW Group, Inc·Product code FTD·January 8, 2007

    Skytron Infinity Series surgical light with triple lightheads, 8 bulbs in 1 - 30' diameter lighthead and 5 bulbs in each of 2 - 22' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Model IN302222EL, IF302222-B, IN30AR2222EL and IN30TV2222EL. (note only the 22'' lightheads are affected).

    FDA Recall
    Terminated ·Skytron, Div. The KMW Group, Inc·Product code FTD·January 8, 2007