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

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    DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODELS DVS-I-11, DVS INSERTION TOOL, DVS-D-A, DVS DOSIMETER

    FDA 510(k)
    FDA Class 2 ·Radiology

    Mini-Sprint®

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR70610511·Mini Sprint-Brackets 5-5 McLaugh/Benn/Trev. .02...

    Kalitec Disc Prep

    FDA UDI
    Kalitec Direct LLC·B07319K0160510·Curette, Right Angle, #5

    ANNULOFLO SYSTEM, MITRAL MODEL AR700

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RX EVEREST

    FDA 510(k)
    FDA Class 2 ·Dental

    LINEAR ST

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 19, 2019

    PRECISION MONTAGE MRI

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 26, 2024

    RU NOVOSIBIRSK

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·October 16, 2013

    ST JOSEPHS PHOENIX, AZ 1

    FDA Adverse Event
    Malfunction ·SORIN GROUP USA·Product code DWF·July 31, 2009

    RU NOVOSIBRIRSK

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·April 11, 2013

    RU NOVOSIBIRSK

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DWF·October 16, 2013

    CP87170 DE MUENCHEN

    FDA Adverse Event
    Death ·SORIN GROUP ITALIA·Product code DTZ·July 15, 2011

    3.0MM TI CERVICAL SPINE LOCKING SCREW 16MM

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code OVE·April 16, 2013

    ACCU-CHEK ACTIVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·June 13, 2008

    OLYMPUS EVIS EXERA DUODENOVIDEOSCOPE

    FDA Adverse Event
    Other ·OLYMPUS MEDICAL SYSTEM CORPORATION·Product code KOG·April 1, 2011

    CP87641 GB SOUTHAMPTON

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DWE·March 22, 2010

    D 100 PH.I.S.I.O. NEWBORN HOLLOW FIBER MEMBRANE OXYGENATOR WITH RESERVOIR

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA S.R.L.·Product code DTZ·March 28, 2017

    Applied Medical's Inzii¿ 12/15mm Retrieval System. Applieds Inzii Tissue Retrieval Bag, Model Number CD004, is classified as a Class II device. It was cleared to market via 510(k) filing K060051. The retrieval bag is a disposable specimen retrieval bag intended for use as receptacle for the collection of tissue, organs, and calculi during laparoscopic procedures. Applieds CD004 has a shelf life of three years. It is provided sterile and packaged in a heat sealed Tyvek pouch.

    FDA Enforcement
    Class II ·Terminated·Applied Medical Resources Corp·November 20, 2013

    Applied Medical's Inzii 12/15mm Retrieval System. Applieds Inzii Tissue Retrieval Bag, Model Number CD004, is classified as a Class II device. It was cleared to market via 510(k) filing K060051. The retrieval bag is a disposable specimen retrieval bag intended for use as receptacle for the collection of tissue, organs, and calculi during laparoscopic procedures. Applieds CD004 has a shelf life of three years. It is provided sterile and packaged in a heat sealed Tyvek pouch.

    FDA Recall
    Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa # 3 Rancho Santa·Product code GCJ·October 21, 2013

    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