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Sources: EU EUDAMED, US FDA
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Spacelabs Ultraview DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT), Model Number 91330
FDA Enforcement
Class II
·Ongoing·Zoe Medical Incorporated·September 18, 2024
Spacelabs Ultraview DM4 Vital Signs Monitor (all variations -M, -N, -MF, -NF, -MW, -NW, -MFW, -NFW), Model Number 91331
FDA Enforcement
Class II
·Ongoing·Zoe Medical Incorporated·September 18, 2024
Spacelabs Ultraview DM3 Monitor Model Number: 91330-NT The Ultraview DM3 Monitor is indicated for use by health care professionals for monitoring patient vital signs. The Ultraview DM3 Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients. Monitored parameters include SpO2, pulse rate, NIBP, and temperature.
FDA Enforcement
Class II
·Terminated·Zoe Medical Incorporated·September 26, 2012
IDM-MICRO-R. Electrical wheelchair component.
FDA Enforcement
Class I
·Ongoing·mo-Vis BVBA·September 10, 2025
IDM-ARLITE-R. Electrical wheelchair component.
FDA Enforcement
Class I
·Ongoing·mo-Vis BVBA·September 10, 2025
All-round Joystick R-net Light. Electrical wheelchair component.
FDA Enforcement
Class I
·Ongoing·mo-Vis BVBA·September 10, 2025
IDM-MULTI-R. Electrical wheelchair component.
FDA Enforcement
Class I
·Ongoing·mo-Vis BVBA·September 10, 2025
Micro Joystick R-net. Electrical wheelchair component.
FDA Enforcement
Class I
·Ongoing·mo-Vis BVBA·September 10, 2025
Multi Joystick R-net. Electrical wheelchair component.
FDA Enforcement
Class I
·Ongoing·mo-Vis BVBA·September 10, 2025
Scoot Control R-net, Product Number P015-61. The Scoot Control is intended to support a wheelchair attendant in controlling or maneuvering a power chair
FDA Enforcement
Class II
·Ongoing·mo-Vis BVBA·January 17, 2024
VITROS chemistry Products Cl- Slides, Catalog No. 8445207 (which does NOT support Urine CL-). MicroSlides which contain reagents in a dry, multi-layered form.
FDA Enforcement
Class II
·Terminated·Ortho-Clinical Diagnostics·November 13, 2019
Implant Retrieval Kit - Product Usage: The kit itself does not have a specific intended Use, but included devices have specific intended use as shown above.
FDA Enforcement
Class II
·Terminated·Nobel Biocare Usa Llc·February 26, 2020
Abutment Screw Retrieval Kit - Product Usage: The kit itself does not have a specific intended Use, but included devices have specific intended use as shown above.
FDA Enforcement
Class II
·Terminated·Nobel Biocare Usa Llc·February 26, 2020
Stryker Vision Mounting Arm, for use with other Stryker Endoscopy medical device products for human patients. Model number 0240-095-200, manufactured by Stryker Endoscopy San Jose The intended use of the Stryker Vision Mount is to hold and position an LCD monitor. The Stryker Vision Mounting Arm can be used with any Stryker flat panel display and is It is compatible with Stryker Carts (0240099001, 0240099011 or 0240099020). It is indicated for use in a surgical operating room environment and is exposed to environmental conditions associated with the storage and shipping of the product. It is not intended to enter the sterile field. The Stryker Vision Mount does not deliver to and/or extract from the patient any energy or material. It does not process any biological materials, as it is not intended to be sterilized by the user. The Stryker Vision Mount is only used to display surgical images and video and does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·October 2, 2013
CAIRE MODEL: FreeStyle Comfort Oxygen Concentrator - Product Usage: The FreeStyle Comfort Oxygen Concentrator is intended for the administration of supplemental oxygen. The device is not intended for life support nor does it provide any patient monitoring capabilities.
FDA Enforcement
Class II
·Terminated·Caire, Inc.·January 22, 2020
Lazervida 10W diode laser cutter and engraver with Lazervida shield.
FDA Enforcement
Class II
·Ongoing·Flux Technology Inc.·June 11, 2025
Straumann SCS Screwdriver, driver, for ratchet, short, L 21mm, stainless steel Article Number: 046.401. dental surgical instrument.
FDA Enforcement
Class II
·Terminated·Straumann USA LLC·August 11, 2021
GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX. The Datex-Ohmeda S/5MT Compact Airway Module, E-CAiOVX family is used for monitoring hospital patients respiration, ventilation, and gas exchange status.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·June 25, 2014
Silhouette Lift brochure Silhouette Sutures are for use in midface suspension surgery to fixate the cheek subdermis in an elevated position.
FDA Enforcement
Class II
·Terminated·Silhouette Lift, Inc.·July 29, 2015
RadiForce RX650, 6MP Color LCD Monitor, Part Code No. 0FTD1957A5, 0FTD195B5, UPC 690592037203. This product is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners. It does not support the display of mammography images for diagnosis.
FDA Enforcement
Class II
·Terminated·Eizo Corporation·July 22, 2015