BEUDAMED
    16 results · 21ms · Sources: EU EUDAMED, US FDA

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    Quantum Workstation 12 Elite

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ARCHITECT C16000

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code JJE·September 13, 2021

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112922·CORNEAL TREPHINE BLADE7.75MM

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112502·BARRON VACUUM TREPHINE 7.75MM

    Blade Scalpel

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113462·SCLEROTOME BLADE #57 (BX/5)

    ARCHITECT C16000 SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES (IRVING IA/CC)·Product code JJE·July 21, 2020

    SUTURE WELDING SYSTEM AND KIT-(J-TIP DESIGN)

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

    NOVAKONE SPHERICAL AND TORIC LENSES

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    TERUMO ADVANCED PERFUSION SYSTEM 1

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEM CORP·Product code DTQ·September 18, 2014

    X3 TRIATHLONG CS INSERT #5 11MM

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS LIMERICK·Product code JWH·August 8, 2011

    ECHELON*FLEX60

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 2, 2013

    ELCA CORONARY LASER ATHERECTOMY CATHETER

    FDA Adverse Event
    Death ·SPECTRANETICS CORPORATION·Product code LPC·May 6, 2026

    TITAN INFLATABLE PENILE PROSTHESIS FAMILY

    FDA Adverse Event
    Injury ·COLOPLAST A/S·Product code FHW·March 9, 2026

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 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

    OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012-44-XXXX; c. OPTETRAK Logic CR Tibial Inserts, Product Line 02-012-47-XXXX; d. OPTETRAK Logic CR Slope + Tibial Inserts, Product Line 02-012-48-XXXX; e. OPTETRAK Logic CR Slope ++ Tibial Inserts, Product Line 02-012-49-XXXX; f. OPTETRAK Logic CRC Tibial Inserts, Product Line 02-012-51-XXXX; g. OPTETRAK Logic CC Tibial Inserts, Product Line 02-012-65-XXXX; Affected 510(k) numbers include: K033883, K132161, K093360, K110547, K111400, K121307, K123342, K150890. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021