BEUDAMED
    19 results · 46ms · Sources: EU EUDAMED, US FDA

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    PARIETEX PROGRIP

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

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172974025·UniTip High Resolution Catheter 10F

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+3MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·August 18, 2022

    MEDCOMP Z-CATH

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MODIFICATION TO BASIC DENTAL IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    AIRSENSE 10 CPAP USA CO

    FDA Adverse Event
    Malfunction ·RESMED LTD·Product code BZD·October 19, 2021

    AIRSENSE 10 CPAP USA CO

    FDA Adverse Event
    Injury ·RESMED LTD·Product code BZD·October 19, 2021

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 9, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

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

    HIRES 90K

    FDA Adverse Event
    Injury ·ADVANCED BIONICS, LLC.·Product code MCM·May 20, 2011

    SURGIQUEST AIRSEAL

    FDA Adverse Event
    Injury ·SURGIQUEST, INC.·Product code GCJ·September 25, 2014

    SURGIQUEST AIRSEAL

    FDA Adverse Event
    Injury ·SURGIQUEST, INC.·Product code GCJ·March 11, 2015

    SURGIQUEST AIRSEAL

    FDA Adverse Event
    Other ·SURGIQUEST, INC.·Product code HIF·December 12, 2013

    Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. . Model Number: 718132

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021

    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

    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