BEUDAMED
    21 results · 31ms · Sources: EU EUDAMED, US FDA

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    TRABECULAR METAL FEMORAL CONE AUGMENTS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CD HORIZON® Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00885074250687·CROSSLINK 8103517 X10 FOR 3.5ROD L 17

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814800·GENUMEDI EXTRA WIDE SILVER SIZE VII

    FlexStep

    FDA UDI
    Liftup A/S·05714420035171·FlexStep V2, 800, 3 step, indoor

    Baby Gorilla®/Gorilla® Plating System

    FDA UDI
    Paragon 28, Inc.·00889795050663·Drill, 3.5 x 190mm, Cannulated, AO

    MINIMUM ESSENTIAL MEDIUM EAGLE (MEM), 210-3517

    FDA 510(k)
    FDA Class 1 ·Hematology

    10600 DEFLECTABLE CATHETER SYSTEM, MODEL 10600

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OTRES TOOTHBRUSH SANITIZER MODEL TB100W

    FDA 510(k)
    FDA Class 1 ·Dental

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·December 23, 2014

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code IOR·May 9, 2013

    PARADIGM INSULIN INFUSION PUMP

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

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 26, 2011

    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

    EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021

    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

    INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f) W173

    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