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

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    ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517636645·CoRoent Ant TLIF PEEK, 12x13x32mm 12°

    RUSCH

    FDA UDI
    TELEFLEX INCORPORATED·04026704541713·PVC NASOPHARYNGEAL AIRWAY STERILE

    Novo Surgical Inc.

    FDA UDI
    NOVO SURGICAL, INC.·00842331145315·sterile surgical blades, box of 100 blades, no. 11

    Prime Medical LLC

    FDA UDI
    Prime Medical LLC·00850055249271·PrimePadPlus-K12-3422

    EVERCROSS 0.035 OTW PTA DILATION CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CORONIS 2MP MEDICAL FLAT PANEL DISPLAY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    WAVEWRITER ALPHA

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 1, 2023

    SYRINGE 0.3ML 30GA 8MM 10BAG 500 L AMR

    FDA Adverse Event
    Malfunction ·EMBECTA MEDICAL I LLC - HOLDREGE, NE·Product code FMF·July 23, 2024

    SYRINGE 0.3ML 30GA 8MM 10BAG 500 L AMR

    FDA Adverse Event
    Malfunction ·EMBECTA MEDICAL I LLC - HOLDREGE, NE·Product code FMF·July 30, 2024

    BD ULTRA-FINE?¿ II INSULIN SYRINGE

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·December 15, 2022

    OT VERIO PRO METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 21, 2013

    6.5CM ADULT CRANI ATTACHMT

    FDA Adverse Event
    Injury ·DEPUY SYNTHES POWER TOOLS·Product code HBC·September 26, 2014

    NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code FYD·June 8, 2011

    THREE PEG PATELLA 41MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·December 26, 2025

    OPTETRAK

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·July 1, 2024

    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 Recall
    Open, Classified ·Exactech, Inc.·Product code JWH·August 30, 2021

    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

    Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000

    FDA Enforcement
    Class I ·Ongoing·Covidien·November 8, 2023