BEUDAMED
    5 results · 7ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii ×

    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

    Natus Neurology ErgoJust Carts labeled as the following: ICU Cart Export For PTZ Video Ext, IP PTZ HD ErgoJust Video Extension, EuroJust ICU Cart Export For PTZ Video Ext. Video cart used for mobile medical record documentation.

    FDA Enforcement
    Class II ·Terminated·Natus Neurology DBA Excel Tech., Ltd. (XLTEK)·August 15, 2018

    IPELA FHD PTZ TILE KITS with Axis cameras used in combination with Natus Neuroworks/Sleepworks software

    FDA Enforcement
    Class II ·Terminated·Natus Neurology DBA Excel Tech., Ltd. (XLTEK)·March 2, 2022

    Ventlab, LLC V-Care manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. V-Care Child Resuscitator REF #s: VN4100MB, VN4100MCFB-3, VN4100MCP; 2. V-Care Infant Resuscitator REF #s: VN3100OB, VN3100MB-2, VN3100MB-M01, VNW3100MB-2, VN3100MBP-3M, VN3100MB, VN3100MB-D1, VN3100MB-M00-0, VN3100MB-M1, VN3100OBP, VN3100MB-B, VN3100MB-I, VN3100MBP-000, VN3100MBP-2, VN3100MB-PW2, VN3100MBP, VN3100MBP-D1, VN3100MBPW-D2, VN3100MBP-F, VN3100MXK-2, VN3100MX-F, VN3100MC-2, VN3100MC, VN3100MC-B, VN3100MC-D1, VN3100MC-2U, VN3106MC-M1-2V, VN3104MCFB- M01, VN3106MC-D2V, VN3106MC-M1V, VN3100MCP-2, VN3100MCP, VN3106MCPF- M1V, VN3100MBF; 3. V-Care Pediatric Resuscitator REF #s: VN2100MB, VN2102MB, VN2102MBF, VN2102OBP, VN2100MBF, VN2100MBP, VN2100MB-PW, VN2102MX, VN2102MX-F, VN2100MX-M123, VN2100MC, VN2102MC, VN2102MC-B, VN2102MCP, VN2100MCP; 4. V-Care Small Adult Resuscitator REF #s: VN5000MB, VN5002MB, VN5100MB-F, VN5000MBPF, VN5000MBPF-I, VN5000MX, VN5100MX-F, VN5000MX-N, VN5000MXP, VN5000MXP-K, VN5000MC, VN5102MC, VN5100MCP, VN5000MC-N.

    FDA Enforcement
    Class II ·Ongoing·SunMed Holdings, LLC·November 29, 2023

    Philips IntelliVue MX4O WLAN Patient Wearable Monitor Product: 865352 Exchange part (service numbers): 453564615311 TELE PWM,802.lla/b/g,ECG only, US only 453564615331 TELE PWM,802.1 1 a/b/g,ECG&Sp02, US only Product Usage: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals. The MX4O is to be used primarily as a traditional telemetry medical device. It connects to the IntelliVue Information Center by way of a wireless network. When the MX4O is connected the IntelliVue Information Center the IntelliVue Information Center provides the primary patient monitoring and alarming function. The MX4O does not automatically provide local monitoring or alarming when connected to the Information Center.

    FDA Enforcement
    Class II ·Terminated·Philips Electronics North America Corporation·April 12, 2017