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

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    M2 SINGLE USE MICROKERTOME

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113578·PRESET 600 MICRON KNIFE (BX/5)

    INSTANT-VIEW FSH Midstream Cassette Test

    FDA UDI
    ALFA SCIENTIFIC DESIGNS, INC.·10796918002164·INSTANT-VIEW FSH Midstream Cassette Test

    Reicodent

    FDA UDI
    devemed GmbH·04061644063482·Rubber-dam clamp forceps "Ivory"

    INSTANT-VIEW FSH Midstream Cassette Test, 2t

    FDA UDI
    ALFA SCIENTIFIC DESIGNS, INC.·10796918002003·INSTANT-VIEW FSH Midstream Cassette Test, 2t

    MCKESSON SYRINGE

    FDA Adverse Event
    Malfunction ·MCKESSON MEDICAL-SURGICAL·Product code FMF·April 6, 2026

    GE LOGIQ A100 MP, MODEL 2272413

    FDA 510(k)
    FDA Class 2 ·Radiology

    SHEEP ANTI-HUMAN IGE IMMUNOFIXATION GRADE KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    NEWLIFE ELITE

    FDA Adverse Event
    Death ·AIRSEP CORP.·Product code CAW·March 22, 2013

    MIRA CR4010 OPHTHALMIC CRYO PROBE

    FDA Adverse Event
    Malfunction ·MIRA, INC.·Product code HPS·February 16, 2011

    V-CAT NEO MAGIC

    FDA Adverse Event
    Other ·HDC CORP.·Product code LJS·March 31, 2008

    BIOMET StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 433175.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

    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

    The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

    FDA Enforcement
    Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014