BEUDAMED
    26 results · 24ms · Sources: EU EUDAMED, US FDA

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    OTSC (OVER-THE SCOPE-CLIP) SYSTEM SET

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Performance Health

    FDA UDI
    Performance Health Supply, LLC·10885914087340·SEIRIN G-TYPE 0.30 X 75mm ACUPUNCTURE NEEDLE 1...

    Sterilance SteriHeel Plus Heel Incision Safety Lancet

    FDA UDI
    Sterilance Medical (Suzhou) Inc.·16945630115018·

    Sterilance SteriHeel Plus

    FDA UDI
    Sterilance Medical (Suzhou) Inc.·16945630111935·

    GUTTA PERCHA POINTS

    FDA UDI
    DiaDent Group International·08806383501040·Gutta Percha Points is used to root canal filin...

    UniTip Catheter

    FDA UDI
    Unisensor AG·07640172971239·

    OPTIMUM WETTING AND REWETTING DROP

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    TRICERAM

    FDA 510(k)
    FDA Class 2 ·Dental

    HS III PROXIMAL SEAL SYTEM 4.3MM

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code DXC·May 3, 2013

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 3, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·May 24, 2011

    MOTOCLIP SUPERELASTIC FUSION SYSTEM

    FDA Adverse Event
    Malfunction ·CROSSROADS EXTREMITY SYSTEMS LLC·Product code JDR·March 29, 2019

    GALAXY G3 MINI 2MM X 4CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·June 16, 2021

    GALAXY G3 5MM X 15CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·June 16, 2021

    GALAXY G3 MINI 3MM X 8CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·June 16, 2021

    GALAXY G3 MINI 2MM X 3CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·June 16, 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

    Spacelabs Healthcare XPREZZON Bedside Monitor, Model 91393. The Spacelabs Healthcare XPREZZON Bedside Monitor passively displays data generated by Spacelabs parameter modules, Flexport interfaces, and other Spacelabs SDLG based products as waveform and numeric displays, trends and alarms. Key monitored parameters available on the model 91393, when employing the Spacelabs Command Module consist of EGG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output.

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

    VALITUDE CRT-P pacemaker, Models: a) U125 b) U128

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·July 14, 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