BEUDAMED
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    Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming Arm and 125 Degree Aiming Arm are a part of the TFN-ADVANCED (TFNA) System. The TFN-ADVANCED Proximal Femoral Nailing System is intended for treatment of fractures in adults and adolescents (12-21) in which the growth plates have fused.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·April 8, 2015

    VOLISTA StandOP Surgical Light, ARD568811961 VLT600DF AIM STP; ARD568821961 VLT600DF AIM STP QL; ARD568811911 VLT600SF AIM STP; ARD568821911 VLT600SF AIM STP QL; ARD568821910 VLT600SF STP QL; ARD568811901 VLT600SF AIM STP Product Usage: The Maquet VOLISTA surgical lights are designed to illuminate the body of a patient during surgical operations, diagnostics and treatment. StandOP VOLISTA is a system of ceiling-mounted surgical lights suited for installation in surgical suites, examining rooms, doctors surgeries and out-patient consultations.

    FDA Enforcement
    Class II ·Terminated·Maquet SAS·July 25, 2018

    Thumb Screw for the Synthes Recon Locking Aiming Arm for Lateral Entry Femoral Nails-EX (part number 03.010.048) and the Thumb Screw for the Aiming Arm for Titanium Cannulated Tibial Nails-EX (part number 03.010.052). The Recon Locking Aiming Arm for Lateral Entry Femoral Recon Nails- EX is used when locking the Femoral Nail-EX. The Aiming Arm for Titanium (TI) Cannulated Tibial Nails-EX is used when locking the Tibial Nail-EX.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·March 25, 2015

    VOLISTA StandOP (model 600) surgical lights shipped from October 2012 until June 2017 equipped with keypads with Ref. ARD568801560; Part numbers: 568811901, VLT600SF AIM STP; 568811911, VLT600SF AIM STP; 568811961, VLT600DF AIM STP; 568821910, VLT600SF STP QL; 568821911, VLT600SF AIM STP QL; 568821960, VLT600DF STP QL; 568821961, VLT600DF AIM STP QL VOLISTA surgical lights are intended to be used to provide visible illumination of the surgical area or patient during surgical operations, diagnostics and treatment.

    FDA Enforcement
    Class II ·Terminated·Maquet SAS·June 6, 2018

    VOLISTA StandOP Surgical Light; Model numbers VLT600 SF AIM STP, VLT600 DF AIM STP, Ref. codes ARD568811901, ARD568811911 ARD568811951, ARD568811961 The device is designed to illuminate the body of a patient during surgical operations, diagnostics and treatment. These surgical lights may be installed in surgical suites, examining rooms, doctors' surgeries and outpatient consultations.

    FDA Enforcement
    Class II ·Terminated·GETINGE US SALES LLC·April 18, 2018

    Synthes Periarticular Insertion Handle for 4.5mm LCP Proximal Tibia Plates and Periarticular Aiming Arm for 4.5mm LCP Proximal Tibia Plates

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·October 14, 2015

    Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2408 ( 3 x 8 channel)

    FDA Enforcement
    Class II ·Terminated·QiG Group LLC·March 30, 2016

    Algostim LLC, Algovita External Pulse Generator, Trial Stimulator, Model 3400

    FDA Enforcement
    Class II ·Terminated·QiG Group LLC·March 30, 2016

    Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2412 ( 2 x 12 channel)

    FDA Enforcement
    Class II ·Terminated·QiG Group LLC·March 30, 2016

    Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229003A Model: VST66DF AIM

    FDA Enforcement
    Class II ·Terminated·Maquet Cardiovascular Us Sales, Llc·July 3, 2019

    Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229002A Model: VST66SF AIM

    FDA Enforcement
    Class II ·Terminated·Maquet Cardiovascular Us Sales, Llc·July 3, 2019

    Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229000A Model: VST60SF AIM

    FDA Enforcement
    Class II ·Terminated·Maquet Cardiovascular Us Sales, Llc·July 3, 2019

    Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229001A Model: VST60DF AIM

    FDA Enforcement
    Class II ·Terminated·Maquet Cardiovascular Us Sales, Llc·July 3, 2019

    Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811901 Model: VLT600SF AIM STP

    FDA Enforcement
    Class II ·Terminated·Maquet Cardiovascular Us Sales, Llc·July 3, 2019

    Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811911 Model: VLT600SF AIM STP

    FDA Enforcement
    Class II ·Terminated·Maquet Cardiovascular Us Sales, Llc·July 3, 2019

    Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811961 Model: VLT600DF AIM STP

    FDA Enforcement
    Class II ·Terminated·Maquet Cardiovascular Us Sales, Llc·July 3, 2019

    Synthes B37 Replacement Screws. M3.5 Screw for insertion handle guide/aiming arm, part numbers 3.113.025 and 03.113.026. Surgical instrument for use with Low Bend Medial Distal Tibia Plate. Orthopedic.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·July 9, 2014

    GIBCO CTS AIM V Serum-Free Media (SFM), Model Number 0870112BK. Tissue and cell culture medium.

    FDA Enforcement
    Class II ·Terminated·Life Technologies, Corp.·August 1, 2018

    Ellex Medical Fixed eye Safety filters Model Integre S LP5532. The filter is located in the binocular mount of the laser delivery head. The filter prevents transmission of treatment laser light to physician eyes while the aiming beam to remain visible. .

    FDA Enforcement
    Class II ·Terminated·Laserex Systems Inc.·April 13, 2016

    GUIDE WIRE 2.2MM X 28IN, Aim/Art Guide wire, Item No. 809222028 - Product Usage: These instruments and delivery systems are used to facilitate implantation of orthopedic medical devices.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019