BEUDAMED
    19 results · 29ms · Sources: EU EUDAMED, US FDA

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    ENDOWAVE INFUSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TWO-LUMEN CENTRAL VENOUS ACCESS KIT WITH HEMOSTASIS VALVE/SIDE PORT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    THE TRABECULAR METAL TECHNOLOGY ACETABULAR AUGMENT SYSTEM, MODELS 4893-XX-YY (ZIMMER), 02-212-05XX1 ( IMPLEX)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    E.CAM, SYMBIA E, SYMBIA S, SYMBIA T SERIES

    FDA Adverse Event
    Injury ·SIMENS MEDICAL SOLUTIONS, USA, INC. MI GROUP·Product code KPS·August 3, 2012

    E.CAM, SYMBIA E

    FDA Adverse Event
    Injury ·SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP·Product code KPS·July 13, 2012

    BD POSIFLUSH¿ NORMAL SALINE SYRINGES,

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·September 20, 2023

    E.CAM, SYMBIA E

    FDA Adverse Event
    Injury ·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code KPS·May 16, 2013

    E.CAM

    FDA Adverse Event
    Injury ·SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP·Product code KPS·January 7, 2014

    SYMBIA T-SERIES

    FDA Adverse Event
    Injury ·SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP·Product code KPS·September 20, 2013

    E.CAM, SYMBIA E, SYMBIA S, SYMBIA T SERIES

    FDA Adverse Event
    Injury ·SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP·Product code KPS·May 31, 2013

    PRECISE PRO RX CAROTID STENT SYSTEM

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code NIM·April 23, 2013

    7700

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·April 8, 2011

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·July 10, 2008

    E.CAM, SYMBIA E

    FDA Adverse Event
    Malfunction ·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code KPS·April 16, 2013

    BD VACUTAINER K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·October 5, 2020

    ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters The MAC(TM) Multi-Lumen Central Venous Access Device with ARROWg+ard Blue(R) permits venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins. The ARROWg+ard(R) technology is intended to help provide protection against catheter-related infections. Clinical data have not been collected that demonstrate the use of the ARROWg+ard(R) antimicrobial surface in decreasing catheter-related infections for this device. It is not intended to be used as a treatment for existing infections, nor is it indicated for long-term use.

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·June 14, 2017

    MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue(R) Access Device, Integral Hemostasis Valve, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters The MAC(TM) Multi-Lumen Central Venous Access Device with ARROWg+ard Blue(R) permits venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins. The ARROWg+ard(R) technology is intended to help provide protection against catheter-related infections. Clinical data have not been collected that demonstrate the use of the ARROWg+ard(R) antimicrobial surface in decreasing catheter-related infections for this device. It is not intended to be used as a treatment for existing infections, nor is it indicated for long-term use.

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·June 14, 2017

    KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE

    FDA 510(k)
    FDA Class 2 ·Neurology

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012