BEUDAMED
    26 results · 17ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii ×

    VTI 8 MHz Surgical Doppler Transceiver Selectabable Channel Ref. Number: 108910 Intraoperative (microvascular and vascular), Intraoperative Neurological, Transesophageal, Transrectal, Laparoscopic and Peripheral Vascular.

    FDA Enforcement
    Class II ·Terminated·Vascular Technology, Inc.·September 19, 2018

    Part # 313.232, 2.0mm Stardrive Screwdriver Bld Slf-Retain Med/66mm MQC, lot # 4363820, mfg. 9/11/2002 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·July 20, 2016

    Part # 313.212, 1.3mm Stardrive Screwdriver Bld Slf-Retain Med/60mm MQC, Lot # 4363780, mfg. 9/18/2002 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·July 20, 2016

    Part # SD313.011, Matrix Neuro Screwdriver Blade MQC/MR Conditional/Short, Lot # UR75220, mfg 7/18/2007 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·July 20, 2016

    Cooper Surgical 2 MHZ Waterproof OB Probe Product The CooperSurgical 2 MHz Waterproof OB probe is for obstetrical use in the labor and department for late term obstetrical examination associated with larger women. The product detects fetal heart beats as an aid for determining fetal viability.

    FDA Enforcement
    Class II ·Terminated·CooperSurgical, Inc.·March 28, 2018

    Nicolet¿ Elite¿ 2 MHz OB Water Proof Probe, Model #: X1L008, Catalog Code: NW20. Intended for non-invasive support, i.e. early detection of fetal life, monitor blood flow before and after surgery, etc.

    FDA Enforcement
    Class II ·Terminated·Natus Neurology Inc·July 19, 2017

    Part # 313.946, Low Profile Neuro Screwdriver Blade/MR Safe/MQC/56mm Medium, Lot # 5053374, mfg 7/27/2005 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·July 20, 2016

    Part # SD313.012, Matrix Neuro Screwdriver Blade MQC/MR Conditional/Med, lot # UR75221 & UR80162, mfg 7/18/2007-8/2/2007 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·July 20, 2016

    Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe Model/Catalog Number: ES-100V3 (device); BT2M20S8C (2 MHz fetal probe). Software Version: N/A Product Description: Hand-held, battery-powered ultrasonic Doppler blood-flow detector with LCD numeric display, used with interchangeable probes to detect vascular blood-flow signals and display heart rate; affected units were packaged with a 2 MHz BT2M20S8C fetal probe and labeled for both vascular and fetal applications.

    FDA Enforcement
    Class II ·Ongoing·Koven Technology, Inc.·April 1, 2026

    Part #313.231, 2.0mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341036, 4363819, 4427699, mfg. 3/4/2002-6/6/2002 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·July 20, 2016

    Part # 313.211, 1.3mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341031, 4363779, 4427697, mfg. 2/28/2002-6/6/2002 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·July 20, 2016

    Screwdriver Blade, Handle, Drill Bit, Part #313.945 Low Profile Neuro Screwdriver Blade/MR Safe/MQC/32mm Short Lot # 5053859 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·July 20, 2016

    P21x/5-1 MHz transducer, Part Number P07698-23 Product Usage: The P21x/5-1 MHz phased array transducer is designed for cardiac, abdominal and obstetric, TCD and orbital exams. It supports 2D with SonoMB Multi Beam Technology and Auto Gain capabilities, SonoHD Imaging Technology, Tissue Harmonic Imaging, M-Mode, Velocity Color Flow Doppler, Color Power Doppler (CDP), Pulsed Wave (PW), TDI Pulsed Wave, and Continuous Wave Doppler.

    FDA Enforcement
    Class II ·Terminated·SonoSite, Inc.·October 23, 2013

    Atlantis PV, 8.5F, 15 MHz Peripheral Imaging Catheter: Sterile, R; Sterilized using irradiation. Product Usage: This catheter is a 15 MHz ultrasound imaging catheter intended to operate with an IVUS instrument for diagnostic imaging. It is used with an 8.5F-introducer sheath and a 0.035 guidewire.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific Corporation·February 5, 2014

    Part #313.221, 1.5mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341033, 4589566, 4703774, 4363781, 4589567, 4793575, 4904305, 4427700,4589568, 4830581, 4532370, 4673943, 4871657, mfg. 2/12/2002-5/23/2005 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·July 20, 2016

    Nicolet¿ Elite¿ 2 MHz OB Probe, Non-Fetal Monitor, Model #: X1L007, Catalog Code: N200. Intended for non-invasive support, i.e. early detection of fetal life, monitor blood flow before and after surgery, etc.

    FDA Enforcement
    Class II ·Terminated·Natus Neurology Inc·July 19, 2017

    Opticross 35 15 MHz Peripheral Imaging Catheter 8F (2.74 mm) X 105 cm Expiration Date June 8th 2021 - July 22nd 2021 Material Number (UPN) # H7493932800350 UDI # 08714729984542 Lot #25754545; 25852104; 2582106; 25856700 Product Usage: intended for ultrasound examination of peripheral vascular pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific Corporation·October 28, 2020

    Brand Name: LimFlow Vector Product Name: LimFlow Vector Model/Catalog Number: VT-US-23

    FDA Enforcement
    Class II ·Ongoing·LimFlow, Inc.·February 4, 2026

    Arial 900 MHz Call Station, Model Number CSK200-900MR, with Firmware version: 1.6.3

    FDA Enforcement
    Class II ·Ongoing·Securitas Healthcare LLC·January 14, 2026

    Arial 900 MHz Call Station, Model Number CSK200-900, with Firmware version: 1.6.3

    FDA Enforcement
    Class II ·Ongoing·Securitas Healthcare LLC·January 14, 2026