BEUDAMED
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    Filters Classification: Class Ii × Status: Terminated × Clear all

    Trauma Large Screws: CANN BONE SCREW 7.0MMX100MMLG CANN BONE SCREW 7.0X105LG CANN BONE SCREW 7.0X105LG CANN BONE SCREW 7.0MMX105MMLG CANN BONE SCREW 7.0X110LG CANN BONE SCREW 7.0X110LG CANN BONE SCREW 7.0MMX110MMLG CANN BONE SCREW 7.0X115LG CANN BONE SCREW 7.0X115LG CANN BONE SCREW 7.0MMX115MMLG CANN BONE SCREW 7.0X120LG CANN BONE SCREW 7.0X120LG CANN BONE SCREW 7.0MMX120MMLG CANN BONE SCREW 7.0X125LG CANN BONE SCREW 7.0MMX125MMLG CANN BONE SCREW 7.0X130LG CANN BONE SCREW 7.0MMX130MMLG RECON SCR LGE 5.5MMDX105MM RECON SCR LGE 5.5MMDX110MM RECON SCR LGE 5.5MMDX115MM RECON SCR LGE 5.5MMDX120MM RECON SCR LGE 5.5MMDX125MM RECON SCR LGE 5.5MMDX130MM ITST ANTI-ROT SCR 6.5MMDX105MM ITST ANTI-ROT SCR 6.5MMDX110MM PERI. SCR 3.5MM X105MML PERI SCR. 6.5MM X 100MM L PERI SCR. 6.5MM X 140MM L PERI SCR. 6.5MM X 100MM L PERI SCR. 6.5MM X 100MM L 3.5MM CORT SCR X 105MM SELFTAP 3.5MM CORT SCR X 110MM SELFTAP 5.5MM X 100MM CANN LKNG SCREW Z NAIL 6.0 X 105 CANC SCREW PT Z NAIL 6.0 X 110 CANC SCREW PT Z NAIL 6.0 X 115 CANC SCREW PT Z NAIL 6.0 X 120 CANC SCREW PT Z NAIL 6.0 X 125 CANC SCREW PT Z NAIL 6.0 X 130 CANC SCREW PT Z NAIL 6.0 X 135 CANC SCREW PT Z NAIL 6.0 X 140 CANC SCREW PT Z NAIL 6.0 X 105 CANC SCREW FA Z NAIL 6.0 X 110 CANC SCREW FA Z NAIL 6.0 X 115 CANC SCREW FA Z NAIL 6.0 X 120 CANC SCREW FA Z NAIL 6.0 X 125 CANC SCREW FA Z NAIL 6.0 X 130 CANC SCREW FA Z NAIL 6.0 X 135 CANC SCREW FA Z NAIL 6.0 X 140 CANC SCREW FA Z NAIL 6.0 X 105 CANC SCREW PT Z NAIL 6.0 X 110 CANC SCREW PT Z NAIL 6.0 X 115 CANC SCREW PT Z NAIL 6.0 X 120 CANC SCREW PT Z NAIL 6.0 X 125 CANC SCREW PT Z NAIL 6.0 X 130 CANC SCREW PT Z NAIL 6.0 X 135 CANC SCREW PT Z NAIL 6.0 X 140 CANC SCREW PT Z NAIL 6.0 X 105 CANC SCREW FA Z NAIL 6.0 X 110 CANC SCREW FA Z NAIL 6.0 X 115CANC SCREW FA Z NAIL 6.0 X 120CANC SCREW FA Z NAIL 6.0 X 125 CANC SCREW FA Z NAIL 6.0 X 130 CANC SCREW FA Z NAIL 6.0 X 135 CANC SCREW FA Z NAIL 6.0 X 140 CANC SCREW FA 3.5X105 CORT SCR 3.5 X 105 CORT SCR SELF TAP 3.5X110 CORT SCR 3.5 X 110 CORT SCR SELF TAP 3.5X115 CORT SCR 3.5 X 115 CORT SCR SELF TAP 3.5X120 CORT SCR 3.5 X 120 CORT SCR SELF TAP 3.5X125 CORT SCR 3.5X130 CORT SCR 3.5X135 CORT SCR 3.5X140 CORT SCR 3.5X145 CORT SCR 3.5X150 CORT SCR 4.5 X 105 CORT SCR SELF TAP 4.5 X 110 CORT SCR SELF TAP 4.5 X 120 CORT SCR SELF TAP 6.5X105 CANC SCR, FULLY THDED 6.5X105 CANC SCR, 16MM THD 6.5X105 CANC SCR, 32MM THD 6.5X110 CANC SCR, FULLY THDED 6.5X110 CANC SCR, 16MM THD 6.5X110 CANC SCR, 32MM THD 6.5X115 CANC SCR, 32MM THD 6.5X120 CANC SCR, 32MM THD

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·September 3, 2014

    FEM PRC LT M/RT L SML FEM PRC RT M/LT L SML FEM PRC LT M/RT L SML+ FEM PRC RT M/LT L SML+ FEM PRC LT M/RT L REG FEM PRC RT M/LT L REG FEM PRC LT M/RT L REG+ FEM PRC RT M/LT L REG+ FEM PRC LT M/RT L LGE FEM PRC RT M/LT L LGE FEM PRC LT M/RT L LGE+ FEM PRC RT M/LT L LGE+ " These devices are indicated for patients with: - Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis. - Previous tibial condyle or plateau fractures with loss of anatomy or function. - Varus or valgus deformities. - Revision of previous arthroplasty procedures. " These devices are indicated for cemented use only. " The Zimmer Unicompartmental Knee System is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·March 21, 2018

    Ossur, J Tong, Sterile, Part/ Description: JT-115/ J TONG MED/LGE-No App; JT-200/ J TONG ASSEMBLY SML/MED; JT-210/ J TONG ONLY SML/MED; JT-400/ J TONG COMPONENT TRAY

    FDA Enforcement
    Class II ·Terminated·Ossur Americas·March 20, 2019

    SURG GOWN POLYREINF LGE CUSTOM 28/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

    FDA Enforcement
    Class II ·Terminated·Customed, Inc·September 9, 2015

    Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare·October 14, 2015

    enFlow IV Fluid Warmer (510k name: EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, MODEL 120). The Enginivity enFlow TM IV Fluid Warmer is intended for warming blood, blood products and intravenous solutions prior to administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia.

    FDA Enforcement
    Class II ·Terminated·Vital Signs Devices, a GE Healthcare Company·July 18, 2012

    Disposable Temperature Probes, (sterile), Sensor diameter: 3mm/0.12 in; 25 units per box. Vital Signs Inc. a GE Healthcare Company, 20 Campus Road, Totowa, NJ 07512 USA, www.gehealthcare.com/vitalsigns. Continuous temperature monitoring.

    FDA Enforcement
    Class II ·Terminated·Vital Signs Devices, a GE Healthcare Company·August 21, 2013

    Corometrics Qwik Connect Plus Spiral Electrode- Model #7000AA0 A fetal scalp circular (spiral) electrode and applicator is a device used to obtain a fetal electrocardiogram during labor and delivery.

    FDA Enforcement
    Class II ·Terminated·Vital Signs Devices, a GE Healthcare Company·November 28, 2012

    GE Healthcare, Discovery 3.0T MR750, 5148810-2, 5373011-2, 5499460-2.

    FDA Enforcement
    Class II ·Terminated·GE Medical Systems, LLC·October 31, 2018

    GE 1.5T Signa HDxt, 3.0T Signa HDxt, Signa Vibrant, HD23 Software and the following model numbers: 2395001, 2395001-2, 2395001-3, 2395001-4, 5269997-2, 5269997-4, 2377062-61, 5127452-3, 5127452, 5337894-3, 5337894-4, 5911000-4, 5911000-5, 53085735308573-2. GE Discovery MR750w 3.0T, Discovery MR750 3.0T, Optima MR450w 1.5T, Discovery MR450 1.5T. The 1.5T Signa HDx family and 3.0T Signa HDx family are a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. IT is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including but not limited to head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·October 2, 2013

    GE Healthcare, Proteus XR/a with wall stand model number 600-0301.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare·January 21, 2015

    GE Healthcare, Treadmill T2100 and Treadmill T2000 with power cord part numbers 408930-001 Rev E, 408930-002 Rev C, or 2028038-008 Rev B. Also Field Replaceable Unit P/Ns 408930-001 Rev E, 408930-002 Rev C. UPDATE: 3-30-2015: T2100 & T2000 Treadmills with power cord part numbers 408930-001, 408930-002, or 2028038-008 Also Field Replaceable Unit P/Ns 408930-001, 408930-002 Product Usage: Used for Exercise Testing, facilitating accurate blood pressure measurements and exercise testing within speed range of 0-13.5 miles per hour.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare·March 25, 2015

    GE Healthcare, SIGNA 1.5T TWINSPEED, SIGNA INFINITY MRISYSTEM, SIGNA 3.0T INFINITY WITH EXCITE, SIGNA 3.0T WITH EXCITE, SIGNA EXCITE 1.5T, SIGNA EXCITE 3.0T, GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM, Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T, SIGNA Contour, Brivo MR355, Optima MR360, GE 1.5T SIGNA HDE MR SYSTEM, Signa Openspeed 0.7T MR SYSTEM, Vectra, SIGNA 0.35T OVATION WITH EXCITE, SIGNA 0.2T PROFILE With EXCITE MRI Systems

    FDA Enforcement
    Class II ·Terminated·GE Healthcare·April 1, 2015

    GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR220 amx

    FDA Enforcement
    Class II ·Terminated·GE Healthcare·May 6, 2015

    GE Healthcare Engstrom Carestation, Engstrom Pro, Cart Only S/5 EC. GE model numbers 1505-8538-000, 1505-9000-000, and 1505-9003-000. Ventilators.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare·March 25, 2015

    GE Healthcare Innova IGS 630. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare·July 8, 2015

    GE Healthcare Innova IGS 530. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare·July 8, 2015

    GE Healthcare Innova 2121IQ. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare·July 8, 2015

    Stand-Alone Resuscitation, T-Piece, part numbers 2063771-001, 2063772-001, 2063773-001, 2063774-001, 2063775-001, M1226442, M1241420, M1241421, M1241424, M1241425, M1241427, M1241430, M1241461, M1241463, M1241464, and M1241589; labeled in part ***GE Healthcare 8880 Gorman Road Laurel, MD 20723 ***www.gehealthcare.com*** Provides the basic equipment required for pulmonary resuscitation of infants.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare·February 12, 2014

    GE Healthcare Automatic Mobile X-Ray (AMX) Series: Brivo XR285amx

    FDA Enforcement
    Class II ·Terminated·GE Healthcare·May 6, 2015