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

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    DEN-MAT POLISHING PASTE

    FDA 510(k)
    FDA Class 1 ·Dental

    X-Box

    FDA UDI
    INNO Holdings, Inc.·M71188012250·PEEK, Ta

    N/A

    FDA UDI
    GEORGE TIEMANN & CO.·B58208012250·INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

    NUPRO® Prophylaxis Paste with Fluoride

    FDA UDI
    DENTSPLY INTERNATIONAL INC.·D0038012251·NUPRO® Prophy Paste, Grape, Fine, Single Box (2...

    Oph.Forceps

    FDA UDI
    KATENA PRODUCTS, INC.·00841668117590·Pierce Colibri Corneal Fcps, .3mm Teeth

    CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM

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

    ACCUSIGN AMP 300, BIOSIGN AMP 300, STATUS DS AMP 300, SYVA RAPID TEST D.A.U.

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    STAT DL 9.5 FR. 40 CC. IAB

    FDA Adverse Event
    Injury ·DATASCOPE CORP.·Product code DSP·October 10, 1998

    1.8MM TI VA LCKNG BUTTRESS PIN WITH T8 STARDRIVE RECESS/22MM

    FDA Adverse Event
    Malfunction ·OBERDORF : SYNTHES PRODUKTIONS GMBH·Product code HWC·December 21, 2017

    STAT DL 9.5 FR. 40 CC. IAB

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·October 10, 1998

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 8, 2014

    ENTERRA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LNQ·October 23, 2012

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·May 28, 2015

    EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mouse, High pH (Link) EnVision FLEX Mini Kit, High pH (Link) EnVision FLEX, High pH (Dako Omnis) Multi-component, sealed package. For in vitro diagnostic use.

    FDA Enforcement
    Class II ·Terminated·Dako North America Inc.·November 11, 2015

    Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021

    ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022

    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