BEUDAMED
    14 results · 27ms · 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 ×

    VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    EXPLANT™

    FDA UDI
    ZIMMER TRABECULAR METAL TECHNOLOGY INC.·00889024311718·

    OLYMPIC WARM-UP

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACUMATCH GXL 15DEG LINER 36MM SZ J

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JDI·April 19, 2024

    CAPSUREFIXNOVUS

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·April 10, 2013

    LANX SPINAL FIXATION SYSTEM

    FDA Adverse Event
    Injury ·LANX, INC.·Product code KWP·April 5, 2011

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR REDWOOD CITY·Product code MGB·May 22, 2008

    PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code KRR·October 15, 2025

    PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code KRR·October 20, 2025

    PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code KRR·October 15, 2025

    SENSE XL TORSO COIL 1.5T Mk2. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567502281, 453567502282, 453567502283, 453567502284, 453567502285, 453567502286, 459801585212.

    FDA Enforcement
    Class I ·Ongoing·Philips North America Llc·July 3, 2024

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    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