BEUDAMED
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    Filters FDA Recall × Status: Terminated × Clear all

    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

    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

    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

    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

    QRS Diagnostic Universal ECG 12 Channel ECG (IEC), Rx only, REF Z-7000-0400, Manufactured for QRS Diagnostic, 14755 27th Ave North, Plymouth, MN 55447 USA. Product Usage: The Universal ECG is an Electrocardiograph Diagnostic System designed to provide measurements and interpretative statements of a patients ECG waveform. The interpreted ECG with measurements and diagnostic statements are provided to the physician on an advisory basis only, for the physician to over read and validate or change the ECG interpretation. The ECG measurements and interpretive statements may be reviewed, edited, distributed electronically or printed. No real time monitoring or alarm capability is provided.

    FDA Recall
    Terminated ·Qrs Diagnostic·Product code LOS·February 16, 2012

    Dual Tip Marker, Sterile Product Usage: A writing instrument intended to mark paper and plastic items around the sterile field during surgery. It has two tips. One is black for miscellaneous use. The other is for surgical skin marking.

    FDA Recall
    Terminated ·Viscot Medical LLC·Product code FZZ·August 22, 2012

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

    FDA Recall
    Terminated ·Philips Electronics North America Corporation·Product code MHX·September 20, 2017

    Non-continuous ventilator accessories under the following brand names: a) REMStar Plus M US model number DS200; b) REMStar Plus M w/Humid AHP model number AHP200H; c) REMStar Plus M w/Humid US model number DS200H; d) REMStar Plus M w/Humid, w/Smartcard, AHP model number AH200HS; e) REMStar Plus M w/Smartcard, US model number DS200S; and f) REMStar Plus w/C Flex Dom model number 1009586. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.

    FDA Recall
    Terminated ·Respironics, Inc.·Product code BZD·October 15, 2007

    3M Bair Hugger(M) Normothermia System, Sterile Full Access Underbody, Model 63700 The 3M Bair Hugger Temperature Management System is intended to prevent and treat hypothermia. In addition, the temperature management system can be used to provide patient thermal comfort when conditions exist that may cause patients to become too warm or too cold. The temperature management system can be used with adult and pediatric patients.

    FDA Recall
    Terminated ·3M Company Health Care Business 3m Center·Product code DWJ·January 23, 2018

    3M Bair Hugger(M) Normothermia System, Full Access Underbody Warming Blanket, REF 63500 The 3M Bair Hugger Temperature Management System is intended to prevent and treat hypothermia. In addition, the temperature management system can be used to provide patient thermal comfort when conditions exist that may cause patients to become too warm or too cold. The temperature management system can be used with adult and pediatric patients.

    FDA Recall
    Terminated ·3M Company Health Care Business 3m Center·Product code DWJ·January 23, 2018

    P28 JAWS Nitinol Staple System kits are designed for use in an osteotomy, arthrodesis and fragment fixation of bones and joints of the foot including fixation of small bone fragments.

    FDA Recall
    Terminated ·Paragon 28, Inc.·Product code JDR·December 19, 2017

    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 Recall
    Terminated ·Mindray DS USA, Inc. d.b.a. Mindray North America·Product code MSX·May 12, 2011

    NAVIO Soft Tissue Protector, included in instrument kits. The NAVIO Tissue Protector is a reusable instrument designed to, when used as instructed, provide the required bone pin spacing for the Navio bone clamps and potentially reduce the amount of patient tissue affected when placing the bone pins.

    FDA Recall
    Terminated ·Smith & Nephew, Inc.·Product code OLO·February 27, 2020

    3M Red Dot Electrodes, Radiolucent Monitoring Electrode with Foam Tape, Catalog No. 2244, (3M ID (SKU): 70-2011-8506-6, SAP ID: 7100212989), packaged 10 electrodes per card, 5 cards per pouch, 20 pouches per shipper box, 1,000 electrodes total per shipper box. The 3M Red Dot Radiolucent Monitoring Electrode with Foam Tape 2244 is intended to be used by healthcare professionals for ECG monitoring. This electrode is disposable, intended for single use, and has been tested for up to 3 days wear.

    FDA Recall
    Terminated ·3M Company Health Care Business 3m Center·Product code DRX·October 6, 2021