BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    TECHFIT DISRP® System

    FDA 510(k)
    FDA Class 2 ·Dental

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694023283·FPS 3.5mm 8mm Wedge Plate

    MORELAND

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295123378·MORELAND REV INST TREPHINE REAMER 14mm 9 IN

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694078085·FPS 3.5/4.0 8mm Wedge Plate Sterile Qty 2

    Applanation Tonometer

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Luna G3 BPAP System

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MATRIX2 STANDARD 360 SR COIL

    FDA Adverse Event
    Injury ·NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORPORATION·Product code HCG·November 19, 2008

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·September 10, 2011

    SMARTSET MV 40G - EO

    FDA Adverse Event
    Injury ·9610921 DEPUY CMW·Product code LOD·July 23, 2013

    TRANSPAC¿ IV MONITORING KIT, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP, Item No. 011-42584-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·November 23, 2016

    PKG, ROTATING HANDLE, RATCHET, INSULATED/SHAFT, P/N 0250080233. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014