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

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

    LICOX temperature probe, Model C8.B

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

    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

    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

    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

    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

    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

    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

    Labeling is as follows: Product labeling: ''***Argon Medical Devices***RE-ORDER NO./REF 193248***12cc Control Syringe***ST/FR/TR/FM w/ Reservoir***This device is designed for the administraion and removal of fluids.***DISPOSABLE*SINGLE USE*DO NOT RESTERILIZE***STERILE EO***STERILIZED BY EtO***Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751 800-927-4669***'' Carton Labeling: ''***Argon Medical Devices***12cc Control Syringe***ST/FR/TR/FM W/ Reservoir***This device is designed for the administraion and removal of fluids.***REF/REORDER NO. 193248***Quantity: 25 ea.***STERILE EO***STERILIZED BY EtO***DISPOSABLE*SINGLE USE*DO NOT RESTERILIZE***Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751 800-927-4669***''

    FDA Recall
    Terminated ·Argon Medical Devices, Inc·Product code IZI·June 27, 2005

    Product consists of a syringe used to inject fluids during an angiographic procedure for fluoroscopic imaging. Labeling is as follows: Product Label ''***Argon Medical Device***10cc Control Syringe FR/TR/FM w/ Reservoir SINGLE USE ONLY***REF/REORDER NO. 093205***This device is designed for the administration and removal of fluids***Quantity: 25ea***NON-STERILE*FURTHER PROCESSING REQUIRED***Eto (ethylene oxide) Sterilization Recommended***1445 FLAT CREEK ROAD - ATHENS, TX 75751***800-927-4669***'' Carton Label ''***Argon Medical Device***10cc Control Syringe FR/TR/FM w/ Reservoir SINGLE USE ONLY***REF/REORDER NO. 093205***This device is designed for the administration and removal of fluids***Quantity: 250ea***NON-STERILE*FURTHER PROCESSING REQUIRED***Eto (ethylene oxide) Sterilization Recommended***1445 FLAT CREEK ROAD - ATHENS, TX 75751***800-927-4669***''

    FDA Recall
    Terminated ·Argon Medical Devices, Inc·Product code IZI·June 27, 2005

    Product consists of a syringe used to inject fluids during an angiographic procedure for fluoroscopic imaging. Labeling is as follows: Product Label ''***Argon Medical Device***REORDER NO./REF 193205***10cc Control Syringe FR/TR/FM w/ Reservoir***This device is designed for the administration and removal of fluids***DISPOSABLE***SINGLE USE ONLY***DO NOT RESTERILIZE***STERILE***EO***STERILIZED BY EtO***Sterile Unless Opened or Damaged***Argon Medical Devices, Inc. 1445 FLAT CREEK ROAD - ATHENS, TX 75751***800-927-4669***'' Carton Label ''***Argon Medical Device***10cc Control Syringe FR/TR/FM w/ Reservoir***This device is designed for the administration and removal of fluids***REF/REORDER NO. 193205***Quantity: 25ea***STERILE***EO***STERILIZED BY EtO***DISPOSABLE***SINGLE USE ONLY***DO NOT RESTERILIZE***Sterile Unless Opened or Damaged***Argon Medical Devices, Inc. 1445 FLAT CREEK ROAD - ATHENS, TX 75751***800-927-4669***''

    FDA Recall
    Terminated ·Argon Medical Devices, Inc·Product code IZI·June 27, 2005

    LifeSync ECG System - Disposable leadwear, Ls-222, Ls-223

    FDA Recall
    Terminated ·GMP Companies/Lifesync Corporation·Product code DRG·January 10, 2007

    Mindray V12 Size: 320 mm X 320 mm X 450 mm N.W.: 3 kg G.W.: 6 kg Qty:1 Manufactured in China Mindray V21 Size: 515 mm X 335 mm X 685 mm N.W.: 8 kg G.W.: 11 kg Qty:1 Manufactured in China One product, V Series monitor, available in two sizes: The V12 has a 12 inch screen, the V21 has a 21 inch screen. The V Series Monitor is a Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices. It also monitors of the following human physiological parameters: 1) ECG waveform derived from 3, 5, 6 and 12 lead measurements, 2) Heart Rate, 3) Pulse Oximetry (Sp O2), 4) ST Segment Analysis, 5) Arrhythmia Detection, 6) Non Invasive Blood Pressure (NIBP), 7) Invasive Blood Pressure (IBP), 8) Cardiac Output (CO), 9) Respiratory Gasses, 10) Respiration Rate, 11) Temperature, It is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner.

    FDA Enforcement
    Class II ·Terminated·Mindray DS USA, Inc. d.b.a. Mindray North America·December 26, 2012

    Mindray V21, Size: 515 mm X 335 mm X 685 mm, N.W.: 8 kg, G.W.: 11 kg, Qty:1 The V-Series Monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indications for use include the monitoring of ECG waveform derived from 3,5,6 and 12-lead measurements, Heart Rate, Pulse Oximetry (Sp)s), ST Segment Analysis, Arrhythmia Detection, Non Invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), Cardia Output (CO), Respiratory Gases, Respiration Rate and Temperature.

    FDA Enforcement
    Class II ·Terminated·Mindray DS USA, Inc. dba Mindray North America·October 29, 2014

    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