BEUDAMED
    19 results · 22ms · 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 ×

    SIMPLEX P BONE CEMENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DS DS I-SERIES

    FDA 510(k)
    FDA Class 2 ·Radiology

    GSIBP BLOOD PRESSURE CUFF

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AIRVO TUBE AND CHAMBER KIT WITH NEBULIZER ADAPTER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·November 23, 2021

    AIRVO TUBE AND CHAMBER KIT WITH NEBULIZER ADAPTER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·April 18, 2022

    AIRVO2 TUBE AND CHAMBER KIT WITH NEBULIZER ADAPTER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·January 18, 2022

    CURLIN INFUSION IV PUMP

    FDA Adverse Event
    Malfunction ·MOOG MEDICAL DEVICES GROUP·Product code FRN·March 18, 2013

    MISTRAL AIR PLUS (115V) BLOWER

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code DWJ·August 18, 2014

    UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS CORK·Product code LPH·April 7, 2011

    HEATED BREATHING TUBE AND CHAMBER KIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·April 5, 2022

    AIRVO TUBE AND CHAMBER KIT WITH NEBULIZER ADAPTER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·November 18, 2021

    AIRVO TUBE AND CHAMBER KIT WITH NEBULIZER

    FDA Adverse Event
    Malfunction ·Product code BTT·October 7, 2021

    FISHER & PAYKEL HEALTHCARE

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code CAF·November 7, 2023

    MOZAIK

    FDA Adverse Event
    Injury ·ISOTIS ORTHOBIOLOGICS INC.·Product code MQV·January 7, 2021

    Integra Mozaik Putty 2.5cc, 5 cc, 10 cc Product Usage: The product is a bone graft substitute composed of collagen (Type 1) and ceramic (IP3-Tricalcium phosphate) matrix in putty and strip forms. The product is intended for use as a bone void filler to fill voids or gaps of the skeletal system in the extremities, spine. and pelvis not intrinsic to the stability of the bony structure. Integra Mozaik is also indicated for use in the treatment of surgically treated osseous defects or osseous defects created from traumatic injury to the bone. Following placement in the bone void or a defect Integra Mozaik is reabsorbed and replaced with bone during the healing process.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·June 20, 2012

    Zeiss brand IOLMaster 500, Model 500, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec, Inc.·November 27, 2013

    IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec AG·December 9, 2015

    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

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015