BEUDAMED
    16 results · 21ms · 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 ×

    QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGA ELISA

    FDA 510(k)
    FDA Class 2 ·Immunology

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040010815·Zirlux 16+ B3 100X22

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526189751·LEVAMED ACTIVE ANKLE SUP BLACK L VI

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526189812·LEVAMED ACTIVE ANKLE SUP BLACK R VI

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450218877·

    INSET II

    FDA Adverse Event
    Injury ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·July 15, 2025

    STERILE LATEX SURGICAL GLOVES (POWDERED) WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS)

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code HWC·July 8, 2014

    STEM: AMISTEM P AMISTEM-P COLLARED STD STEM SIZE 5

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·February 7, 2022

    SYNDEO SYRINGE PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code MEA·October 8, 2009

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC.·Product code LFR·May 16, 2007

    RESTORE SENSOR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·March 19, 2013

    BIOFINITY SPHERE (COMFILCON A)

    FDA Adverse Event
    Injury ·COOPERVISION MANUFACTURING LIMITED·Product code LPM·March 7, 2011

    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

    Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018