BEUDAMED
    18 results · 23ms · Sources: EU EUDAMED, US FDA

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    BEHIND EAR GENTLE TOUCH THERMOMETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    K2M General Instruments

    FDA UDI
    VB Spine LLC·10888857520592·Split Tube Retractor, Size Ø18x110 mm

    CENTRAL VENOUS CATHETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BIO-RAD PLATELIA TOXO IGG TMB

    FDA 510(k)
    FDA Class 2 ·Microbiology

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 10, 2013

    SENSOR ENLITE

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OZO·September 19, 2014

    ZUK FEMORAL COMPONENT, HIGH FLEX

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code HSX·May 24, 2011

    THROMBUSTER II

    FDA Adverse Event
    Malfunction ·KANEKA CORPORATION·Product code MMY·March 17, 2014

    THROMBUSTER II

    FDA Adverse Event
    Malfunction ·KANEKA CORPORATION·Product code DXE·October 23, 2012

    THROMBUSTER II

    FDA Adverse Event
    Malfunction ·KANEKA CORP.·Product code DXE·December 21, 2012

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·June 30, 2023

    THROMBUSTER II

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code DXE·January 16, 2019

    SPECIFIC DEVICE NOT REPORTED

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·May 23, 2024

    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

    VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Spacelabs Healthcare qube Compact Monitor, Model 91390. The Spacelabs Healthcare qube Compact Monitor (91390), functioning as either bedside or central monitors; passively displays data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. Key monitored parameters available on the Model 91390 when employing the Spacelabs Command Module, consist of ECG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·March 4, 2015

    GE Healthcare Centricity Radiology RA600 (RA600), Model Numbers: 1) 2022296-001; 2) 2033901-001; 3) 2038437-001; 4) 2038437-011; 5) 2038437-012; 6) 2038437-013; 7) 2038437-014; 8) 2038437-0XX; 9) 2098071-004; 10) 2109571-002; 11) 2109571-006; 12) 2109571-010; 13) 2109594-009; 14) 2109594-011; 15) K2090PS; 16) K2090PTED; 17) MANLEGACY114; 18) MANLEGACY64.

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare·April 9, 2025