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

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    1.5T HEAD COIL (HC150), 3T HEAD COIL (HC300)

    FDA 510(k)
    FDA Class 2 ·Radiology

    Drive

    FDA UDI
    Drive Devilbiss Healthcare·50822383119293·Cane,Ortho K Grip,6/cs

    Navigation Instruments

    FDA UDI
    VB Spine LLC·10888857523869·MI Awl-Tap, Special Connector Size Ø8.5 mm

    YELLOW SPECIAL

    FDA 510(k)
    FDA Class 2 ·Dental

    FORCE FIBER GREEN ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE NON ABSORBABLE SUTURES MODEL:X-5000FFK, X-5001FFK, X-5002FFK

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    LUX 1440

    FDA Adverse Event
    Malfunction ·PALOMAR MEDICAL TECHNOLOGIES, INC.·Product code GEX·May 5, 2012

    CAIMAN DISP.INSTR.NON ARTICUL.D:5/360MM

    FDA Adverse Event
    Malfunction ·AESCULAP, INC.·Product code GEI·March 4, 2015

    SYNGO SUITE FOR ONCOLOGY SYSTEM

    FDA Adverse Event
    Malfunction ·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code MUJ·November 9, 2012

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·May 9, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 19, 2014

    SEE H-10

    FDA Adverse Event
    Malfunction ·STAAR SURGICAL COMPANY·Product code HQL·May 26, 2011

    7F ZUMA 2 SR3.0 100CM CATHETER Z27SR30 Z2 7F 100CM SR30 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z27SR30

    FDA Recall
    Terminated ·Medtronic, Inc.·Product code DQY·April 5, 2006

    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

    INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (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

    Hemodialysis Delivery System, Software Version 2.x.

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·November 17, 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

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018