BEUDAMED
    19 results · 30ms · Sources: EU EUDAMED, US FDA

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    MSD SILO SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CD HORIZON® Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00613994325792·CONNECTOR 7042210 LAT CONN TI 4.5 12MM

    JOBST forMen

    FDA UDI
    BSN MEDICAL, INC.·04042809874976·FOR MEN 15-20 MM HG THIGH MICRO DOT BAND OPEN T...

    23GA Straight Laser Probe, SMA905

    FDA UDI
    Peregrine Surgical, Llc·00632307002069·23GA Straight Laser Probe, SMA905

    SOAR Retractor System

    FDA UDI
    SPINEOLOGY INC.·M7403042210·22mm x 100mm Portal Tube

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K0122100·T-Handle, Head Persuader

    SYNTRA DIALYZER, MODEL SYNTRA 120, 160

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

    MODIFICATION TO ACCU-CHEK INFORM METER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    NUVASIVE

    FDA Adverse Event
    Injury ·NUVASIVE·Product code NKB·January 10, 2011

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·February 20, 2025

    ASR UNI FEMORAL IMPL SIZE 47

    FDA Adverse Event
    Malfunction ·DEPUY INTERNATIONAL·Product code KWA·April 9, 2013

    HGP II ACETABULAR COMPONENTS BONE SCREW

    FDA Adverse Event
    Malfunction ·ZIMMER, INC.·Product code JDI·February 15, 2011

    ENDOTAK RELIANCE G

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008

    ARROW CVC SET: 2-LUMEN 4 FR X 5 CM

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL LLC·Product code DQY·September 10, 2024

    ARROW CVC SET: 2-LUMEN 7 FR X 20 CM

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL LLC·Product code FOZ·August 8, 2023

    EBI XFIX DFS Rail System (Adult Rail Gradual Swivel Clamp). The Biomet Rail System consists of a unilateral external fixator rail, modular bone screw clamps, and compression and distraction units. The device is used in the treatment of bone fractures.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·December 26, 2012

    FLS - Foot Locking Plates System and HOL - Hallux Osteotomy Locking Plate with the below descriptions and corresponding article numbers. 1. FLS - Foot Locking Plates System, Cancellous Stabilization Screw; Article Numbers: 37303-10, 37303-12, 37303-14, 37303-16, 37303-18, 37303-20, 37303-22, 37303-24, 37303-26, 37303-28, 37303-30. 2. FLS - Foot Locking Plates System, Cortical Screw; Article Numbers: 32271-10, 32271-12, 32271-14, 32271-16, 32271-18, 32271-20, 32271-22, 32271-24, 32271-26, 32271-28, 32271-32, 32271-34. 3. FLS - Foot Locking Plates System, Cortical Stabilization Screw; Article Numbers: 37304-10, 37304-12, 37304-14, 37304-16, 37304-18, 37304-20, 37304-22, 37304-24. 4. FLS - Foot Locking Plates System, FLS Plate, Curved; Article Numbers: 21413-6. 5. FLS - Foot Locking Plates System, FLS Plate, H-Shape; Article Numbers: 21431-ME. 6. FLS - Foot Locking Plates System, FLS Plate, L-Shape; Article Numbers: 21482, 21483. 7. FLS - Foot Locking Plates System, FLS Plate, Straight; Article Numbers: 21421-5. 8. FLS - Foot Locking Plates System, Stabilization Screw; Article Numbers: 37241-10, 37241-12, 37241-14, 37241-16, 37241-18, 37241-20, 37241-22, 37241-24, 37241-26, 37241-28, 37241-30. 9. HOL - Hallux Osteotomy Locking Plate, Hallux Osteotomy Plate; Article Numbers: 21015-08, 21015-09.

    FDA Enforcement
    Class II ·Ongoing·I.T.S. GmbH·April 1, 2026

    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·May 8, 2024

    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