BEUDAMED
    22 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 ×

    GENSTRIP TEST STRIP MODEL 100-201

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Neodent

    FDA UDI
    JJGC Indústria e Comércio de Materiais Dentários S/A.·07899878047124·NGS REGULAR TAPERED DRILL

    RINGLOC HIP SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304001602·

    RINGLOC HIP SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304229587·

    SELF CENTERING

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295003328·SELF CENTERING BI-POLAR HEAD 28mm ID 42mm OD

    PREAMP CABLE, MODEL B400-1011PA

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DENTIN CONDITIONING AND ADHESIVE SYSTEM (BOND-1)

    FDA 510(k)
    FDA Class 2 ·Dental

    FETAL MONITOR/CARDIOTOCOGRAM

    FDA Adverse Event
    Injury ·BISTOS CO., LTD.·Product code HGL·January 29, 2018

    PRECISION®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 9, 2013

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·September 19, 2014

    PERMANENT CAUTERY SPATUAL INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·May 26, 2011

    TPRLC XR T1 PPS 13X146MM

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code LPH·May 15, 2025

    TPRLC 133 MP TYPE1 PPS HO 15.0

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code KWA·May 15, 2025

    TPRLC XR FP TYPE1 PPS 4X128MM

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code LPH·May 15, 2025

    PRESIDIO 10 CERE 6MMX26CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code HCG·May 10, 2021

    The PrisMax System Version II Hemodialysis Delivery System: Automatic Repositioning System Pump Assembly, specifically tubing, Model Numbers: a) 955626 b) 955558 c) 955701 PrisMax V2 Preventive Maintenance Kit, Product Code SC616 ARPS PUMP, Product Code SC6035 ARPS Pump Assembly, Product Code SC6053

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·March 10, 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

    VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021