BEUDAMED
    14 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 ×

    Qitexio® 4-Way Stopcock (QIT014)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MITEK

    FDA UDI
    Medos International Sàrl·10886705029136·Button top trocar for 5.9 mm sheath compatible ...

    Vilex Power Accessory

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731122315·KWire .094 x 9" (2.4x225mm)

    MORELAND

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295123330·MORELAND REV INST TREPHINE REAMER 17mm 5.5 IN

    Portex

    FDA UDI
    ICU MEDICAL, INC.·15019517110845·

    Skypro, SP02 Mask (3)

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

    EZSensor XHD

    FDA 510(k)
    FDA Class 2 ·Dental

    MATRIX2 STANDARD 360 SR COIL

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

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011

    G2

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·July 2, 2013

    Echostar Spica 1.5T MRI system, for magnetic resonance imaging of the body.

    FDA Recall
    Terminated ·Alltech Medical Systems America Inc·Product code LNH·January 9, 2015

    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, NEEDLE HOLDER, STRIAGHT, P/N 0250080340. 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

    Bayer brand A1CNow+ MULTI-TEST A1C SYSTEM TEST KITS (PART NUMBER 3021/08842610); Hemoglobin A1c Monitor; Glycosylated Hemoglobin Assay; Product is manufactured and distributed by Bayer HealthCare LLC, Sunnyvale, CA The A1CNow+ test provides quantitative measurement of the percent of glycated hemoglobin (%HbA1c or %A1C) levels in capillary (fingerstick) or venous whole blood samples. The test is for professional use to monitor glycemic control in people with diabetes.

    FDA Recall
    Terminated ·Bayer Healthcare Llc·Product code LCP·August 26, 2013