BEUDAMED
    12 results · 28ms · Sources: EU EUDAMED, US FDA

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    LAKE MALE EXTERNAL CATHETERIZATION KIT

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    icotec Lumbar Cage PLIF 0° / 25 mm x 08 mm

    FDA UDI
    icotec AG·07640164848228·icotec Lumbar Cage PLIF 0° / 25 mm x 08 mm

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/13 MM R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·May 10, 2022

    FAST-FIX 360 MENISCAL REPAIR SYSTEM, STRIAGHT, CURVED, REVERSE CURVED,FAST FIX 360 AB MENISCAL REPAIR SYSTEM, STRAIGHT,

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    EQUIPMENT DRAPES

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 30, 2014

    RIATA ACTIVE FIXATION

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·January 8, 2013

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER CORP., MEDICAL DIVISION·Product code FNL·November 12, 2010

    Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·November 12, 2025

    UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·August 13, 2025

    Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025

    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