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

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    BACTEC PEDS PLUS/F CULTURE VIALS

    FDA 510(k)
    FDA Class 1 ·Microbiology

    BD BACTEC PEDS PLUS/ F CULTURE VIALS

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code MDB·July 14, 2021

    HENNSON INTERNATIONAL DENTAL CAD/CAM SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    ICOR CALARIC MEASUREMENT UNIT (CMU)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code JFY·February 11, 2013

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·January 10, 2011

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·July 24, 2014

    The RIO (TGS 2.), Model # MAKO TGS 2.0 (Part No. 204000). The RIO is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. The RIO is indicated for use in surgical knee and hip procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These procedures include: Unicondylar knee replacement (UKA) and/or Patellofemoral knee replacement (PKA) and Total Hip Arthroplasty (THA).

    FDA Recall
    Terminated ·Mako Surgical Corporation·Product code OLO·September 12, 2012

    Tibial Array and Femoral Array. Model Number(s): 0150ARR00001 and 0150ARR00002. Manufactured by: MAKO Surgical, Corp. The devices are accessories used with MAKO's Tactile Guidance System (TGS). The Tactile Guidance System is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.

    FDA Recall
    Terminated ·Mako Surgical Corporation·Product code HAW·May 2, 2008

    MAKO PN 204588 Camera 204588 Label With Camera Stand Number ***PN 200294 SN CAM XXX 2011-01.*** Weight 86.2kg.***Class I Equipment. Conforms to IEC 60601-1/A2: 1995, EN 60601-1/A2: 1995, UL 60601-1: 2003, CAN/CSA-C22.2 No. 601.1-M90.*** Manufactured in USA*** MAKO SURGICAL CORP. 2555 Davie Road, Ft. Lauderdale, FL 33317.*** 204589 Robot Arm Label***PN 203999 SN ROB XXX 2011-01.***V 100/120/230 A 9.6/8.0/4.2 Hz 50/60***Weight 39.4kg***Class I Equipment Conforms to IEC 60601-1/A2: 1995, EN 60601-1/A2: 1995, UL 60601-1:2003 CAN/CSA-C22.2 No. 601-1-M90.***Manufactured in USA***MAKO SURGICAL CORP. 2555 Davie Road, Ft. Lauderdale, FL 33317.*** 204588 Label With Guidance Module Number***PN 201251 SN GUD XXX 2011-01***Weight 51.7kg***Class I Equipment. Conforms to IEC 60601-1/A2: 1995, En 60601-1/A2: 1995, UL 60601-1: 2003, CAN/CSA-C22.2 No. 601.1-M90***Manufactured in USA***MAKO SURGICAL CORP. 2555 Davie Road, Ft. Lauderdale, FL 33317.*** THE RIO uses an infra-red camera for the purpose of spatial navigation. This camera is present on the Camera Stand and communicates with the Guidance Module to provide the locations of the tracked instruments (i.e. robotic-arm, patient trackers, probes, etc). The information is then used to provide the virtual representation of the patient anatomy and the tools on the monitor, and provides necessary information to the robotic-arm to ensure proper bone preparation.

    FDA Recall
    Terminated ·Mako Surgical Corporation·Product code KQM·October 25, 2010

    Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAX Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical drugs, blood, blood products and mixture if required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluids. Spectrum infusion pump is intended to be used in conjunction with legally marketed intravenous administration sets and medications provided by user. The Spectrum and Spectrum with MAster Drug Library is intended to reduce operator interaction through automated programming thereby helping to reduce errors associated with complex device programming.

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·May 16, 2018

    200996-Cable Assembly, Hybrid Extended Length, 200997 Cable Assembly, Hybrid, Guidance Module, 200998 Cable Assembly, Hybrid, UI Panel Subcomponents for the 203000 RIO STANDARD SYSTEM Manufactured by: MAKO Surgical, Corp. Fort Lauderdale, FL. All three cables are integral components and are not purchased separately. However, 200996-Cable Assembly is the only cable visible. This cable is labeled: 200996-REV-1, KSM 390634-1, SN 000001. 200997 and 200998 Cable Assembly are not visible . The Tactile Guidance System v2.0 is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.

    FDA Recall
    Terminated ·Mako Surgical Corporation·Product code HAW·July 17, 2009