BEUDAMED
    17 results · 23ms · Sources: EU EUDAMED, US FDA

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    FlareHawk Interbody Fusion System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OnX Tough 2 - Bleach - 3kg

    FDA UDI
    Sprintray, Inc.·00850070544573·SprintRay OnX Tough 2 is a tooth shade ceramic-...

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112939·CORNEAL TREPHINE BLADE8.0MM

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112779·BARRON VACUUM PUNCH 8.0MM

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112991·CORNEAL TREPHINE BLADE16MM

    ENDOSCOPE SET FOR MAGNETIC RESONANCE (MR), MODELS 8767.412, 8767.121 & 8767.452

    FDA 510(k)
    FDA Class 2 ·Neurology

    FLUOROSCAN PROFILE, MODEL TCA 4 PLUS; FLUOROSCAN PROFILE IQ, MODEL TCA 4R PLUS

    FDA 510(k)
    FDA Class 2 ·Radiology

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·May 19, 2022

    WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code NGV·July 12, 2021

    ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE SYSTEM

    FDA Adverse Event
    Malfunction ·CORDIS CORPORATION·Product code NTE·October 16, 2008

    PLV-102B

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC.·Product code CBK·June 28, 2013

    ALLERGAN

    FDA Adverse Event
    AMO SALES & SERVICE, INC·Product code HQC·August 5, 2011

    UNKNOWN KNEE PATELLA

    FDA Adverse Event
    Malfunction ·DEPUY ORTHOPAEDICS INC US·Product code JWH·September 9, 2022

    FLEX 60 ARTICULATING

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

    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

    AcuTwist Acutrak Compression Screws Part Number/Part Description: AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw AI-0018-S 18mm AcuTwist¿ Acutrak Compression Screw AI-0020 20mm AcuTwist¿ Acutrak Compression Screw AI-0020-S 20mm AcuTwist¿ Acutrak Compression Screw AI-0022-S 22mm AcuTwist¿ Acutrak Compression Screw AI-0024-S 24mm AcuTwist¿ Acutrak Compression Screw AI-0026 26mm AcuTwist¿ Acutrak Compression Screw AI-0026-S 26mm AcuTwist¿ Acutrak Compression Screw AI-0028-S 28mm AcuTwist¿ Acutrak Compression Screw AI-0030 30mm AcuTwist¿ Acutrak Compression Screw AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw

    FDA Enforcement
    Class II ·Ongoing·Acumed LLC·January 4, 2023

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021