BEUDAMED
    16 results · 23ms · 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 ×

    ATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Channels

    FDA UDI
    HENRY SCHEIN, INC.·10304040160951·Channels Flex 31mm 25.06

    Safco extruder guns

    FDA UDI
    SAFCO DENTAL SUPPLY CO.·D72310205750·Safco Easy Dispenser impression gun

    APC™ II Unitek™ Mini Uni-Twin

    FDA UDI
    3M UNITEK CORPORATION·00652221062611·Mini Uni-Twin(TM) Bracket APC(TM) II UL1 17T/5A...

    ENDOPATH ELECTROSURGERY PROBE PLUS II

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code GEI·January 29, 2001

    INTER-OP DURASUL ACETABULAR INSERTS (4MM)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GLOBAL ADVANTAGE EXTENDED HUMERAL HEAD

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BD CUSTOM KIT

    FDA Adverse Event
    Injury ·BECTON DICKINSON AND COMPANY·Product code KYG·December 24, 2008

    10MM INZII RETRIEVAL SYSTEM 10/BOX

    FDA Adverse Event
    APPLIED MEDICAL·Product code GCJ·March 20, 2013

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·February 16, 2011

    OBTAPE SLING

    FDA Adverse Event
    Injury ·MENTOR·Product code FTL·March 28, 2008

    UNK_SMART TOUCH BIDIRECTIONAL

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code LPB·June 20, 2023

    ECHELON 60

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·December 15, 2023

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    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