BEUDAMED
    111 results · 19ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Status: Terminated ×

    Thermage Face Tip 3.0, REF/UDI: TTNS3,00C3-400/UDI (01)000850608002377; REF TTNS3.00C3-600/UDI (01)000850608002384; REF TTNS3.00C3-900; UDI (01)000850608002391 Used in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

    FDA Enforcement
    Class II ·Terminated·Solta Medical Inc·April 15, 2020

    EM2 NC AEM Monitor (NON-COM)

    FDA Recall
    Terminated ·Encision, Inc.·Product code GEI·June 23, 2003

    EM2M NC AEM Monitor, (NON-COM)

    FDA Recall
    Terminated ·Encision, Inc.·Product code GEI·June 23, 2003

    EM2+A NC AEM Monotor (NON-COM)

    FDA Recall
    Terminated ·Encision, Inc.·Product code GEI·June 23, 2003

    Philips SureSigns VSi / SureSigns VS2+ vital signs monitor used in healthcare environments and transport within a facility.

    FDA Enforcement
    Class III ·Terminated·Philips Electronics North America Corporation·December 27, 2017

    Kit Model #650305414, MTO Left Heart with DT Boulder Com Hosp - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Management finished good product families and potentially other devices designed and manufactured by original equipment manufacturers (OEM).

    FDA Enforcement
    Class II ·Terminated·Medline Industries Inc·October 14, 2020

    DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 The Central Monitoring Station (CMS) network transfers information between DOM Central Station and other network devices. It also allows information transfer between several CMS. Network connections consist of hardwired network cables and or WLAN connections. The DPM Central Station is used for remote monitor management, storing, printing, reviewing, or processing of information from net worked devices, and it is operated by medical personnel in hospitals or medical institutions.

    FDA Enforcement
    Class II ·Terminated·Mindray DS USA, Inc. d.b.a. Mindray North America·January 9, 2013

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Recall
    Terminated ·CareFusion 303, Inc.·Product code FRN·July 21, 2015

    JOGRAPHY Cardiovascular Angiographic Catheter, 5F *** pigtail *** tapered with perfusion ports *** MEDI-DYNE, INC., 604 Queensbury Ave., Queensbury, New York 12804 *** Single use, sterile, disposable intravascular catheters with an atraumatic tip.

    FDA Recall
    Terminated ·Jomed Catheters, Inc.·November 21, 2002

    Keyspan High-High Speed USB to Serial Adapter Product Usage: The Reporting Software is an application which serves as middle ware between the Tosoh Automated HPLC G8 analyzer and an LIS or as a stand alone data repository for the analyzer. It is designed to store and manage the received data and make reports as necessary. The application is installed on Dell All- in-One computers that do not have serial (RS232) ports only USB ports. The G8 analyzer does not have USB ports. The Key Span Adaptor connects the serial port on the G8 to the USB port on the Dell computer. Once installed the Keyspan adapter is assigned a COM port. The default for the firmware is dynamic which randomly assigns a port for the transmission of data. The port assignment can change when the power for the analyzer or computer is shut down or the cable is physically disconnected and then reconnected. The default can be changed to geographic which allows the port assignment to be static regardless of a power outage.

    FDA Enforcement
    Class II ·Terminated·Tosoh Smd Inc·March 1, 2017

    Ulnar Shorting Saw Blade is labeled in part: "Congruent Bone Plates, SIZE Ulnar Shortening Saw Blade - Hub Style S, REF 80-0499-S, Material: Stainless Steel, STERILE, Rx Only, ACUMED, Hillsboro, OR, USA". The Ulnar Saw Blade is an accessory used with a Congruent Bone Plate System covered under K012655, but it is labeled and sold separately by itself. The saw blade is also sold as part of the Upper Extremity Osteotomy System (BOM 15-0030). The BOM 15-0030 system does not have a label, but the saw blade is individually labeled and shipped together with this system when it is ordered. Intended use: Cutting Bones

    FDA Recall
    Terminated ·Acumed LLC·Product code HRS·April 14, 2010

    Bari Maxx II, KCI''s BariMaxx II bariatric bed, P/N 310611, November 2001, KCI The Clinical Advantage, P. O. Box 659508, San Antonio, Texas 78265-9508, Call Toll Free 1-800-531-5346, FAX (210) 308-3998, Http://www.kci1.com

    FDA Recall
    Terminated ·Kinetic Concepts, Inc·Product code FNL·August 16, 2004

    Large Stealth Chamber, Catalog Numbers: DS50-001-XL-T, DS50-002-XL-T, DS50-003-XL-T, DS50-102-XL-T, DS50-103-XL-T

    FDA Recall
    Terminated ·Iba Dosimetry·Product code IYE·April 26, 2017

    Phantom Nail System, Drill, 4.6 x 300mm, Cannulated, 3/16" Sq. Connection p28 P99-110-4630

    FDA Recall
    Terminated ·Paragon 28, Inc. 14445 Grasslands Dr Englewood CO 80112-7062·Product code HTW·July 30, 2021

    POM Procedural Oxygen Masks, Endoscopic, Conscious Sedation, Bronchoscopy Mask, as follows: (1) POM Medical, LLC, REF 1001-MM, High/Med Concentrations, Distributed by POM Medical, LLC, Moorpark, CA; (2) curaplex, REF 301-0318LT, Medium Concentration, Distributed by Sarnova HC, LLC's family of companies: Bound Tree Medical, LLC, Cardio Partners, Inc., Emergency Medical Products, Inc. & Tri-anim Health Services, Inc., Dublin, OH; and (3) POM Medical, LLC REF 1001-MF, High/Med Concentrations, Distributed by POM Medical, LLC, Moorpark, CA. All are packaged 1 mask/plastic pouch, 30 masks/case.

    FDA Enforcement
    Class II ·Terminated·POM Medical LLC·November 6, 2019

    TECOTHERM NEO, 100-130/200-240 VAC, 50-60 Hz/ max. 350VA, Class I, Schutzklasse I IP 20, UDI: 04260498580002 - Product Usage: The Thermo-Regulation System TECOTHERM NEO is designed for controlled cold & heat treatment procedures. By means of a mattress, cold and heat is provided to the patient, depending on the therapy objective.

    FDA Enforcement
    Class II ·Terminated·Tec Com Gmbh·November 20, 2019

    Kit Model #650305414, MTO Left Heart with DT Boulder Com Hosp - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Management finished good product families and potentially other devices designed and manufactured by original equipment manufacturers (OEM).

    FDA Recall
    Terminated ·Medline Industries Inc·Product code OEQ·September 14, 2020

    CORFLO Percutaneous Endoscopic Gastrostomy (PEG)Kit

    FDA Recall
    Terminated ·Avanos Medical, Inc.·Product code PSG·March 16, 2020

    BRANSIST safire Product Usage: DIGITAL ANGIOGRAPHY SYSTEM This system is intended to be used for radiologic visualization of the heart, blood vessels or lymphatic system during or after injection of a contrast medium. It is to be used in the diagnosis of the circulatory vascular system while being combined with a positioning device and other devices.

    FDA Recall
    Terminated ·Shimadzu Medical Systems Usa Com·Product code IZI·January 14, 2019