BEUDAMED
    18 results · 22ms · Sources: EU EUDAMED, US FDA

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    SimpleSENSE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Dornier Thulio Performance Fiber

    FDA UDI
    INNOVAQUARTZ LLC·00816959021887·

    Dornier MedTech

    FDA UDI
    DORNIER MEDTECH AMERICA, INC.·00810116023448·THULIO LL-R TM 200µM 3M PERF. FIBER 3ST 10X USE

    Classic by RISKONTROL

    FDA UDI
    ACTEON MANUFACTURING·03760243001093·Disposable single use tips for air/water syring...

    6450 RV2 MASK

    FDA UDI
    HANS RUDOLPH, INC.·00874750004928·DISP V2 PET FACEPC/HG/MASK ADP

    Puget Sound Energy - 18 Metal

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588014692·Puget Sound Energy - 18 Metal

    PHYSICIAN'S DESKTOP REVIEW

    FDA 510(k)
    FDA Class 2 ·Radiology

    HANGER CRANIAL BAND

    FDA 510(k)
    FDA Class 2 ·Neurology

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code NEW·April 4, 2018

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAM·June 6, 2018

    CONTINUUM TM SHELL WITH CLUSTER HOLES

    FDA Adverse Event
    Injury ·ZIMMER INC·Product code LZO·June 28, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 17, 2014

    EXTERNAL NEUROSTIMULATOR, UNKNOWN

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LGW·August 17, 2016

    EXTERNAL NEUROSTIMULATOR, UNKNOWN

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LGW·August 17, 2016

    Dexcom G4 PLATINUM (Professional) Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black. Intended to detect trends and track glucose patterns in persons with diabetes. The G4 PLATINUM CGM System and G4 PLATINUM (Professional) CGM System use the same receiver, MT20649. The kits differ due to other kit contents, such as indications for use and professional receiver shield.

    FDA Enforcement
    Class I ·Terminated·Dexcom Inc·April 20, 2016

    EMBLEM MRI S-ICD Model A219

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·February 17, 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