BEUDAMED
    22 results · 22ms · Sources: EU EUDAMED, US FDA

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    BIOPLEX 2200 HSV-1 AND HSV-2 IGG KIT

    FDA 510(k)
    FDA Class 2 ·Microbiology

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970560·

    SPECIMEN RETRIEVAL SYSTEM

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

    GLO-SPEC I, II AND III

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172973479·

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970881·

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172973080·

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172973707·

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970362·

    ENDURO MENISCAL COMPONENT F2 22MM

    FDA Adverse Event
    Malfunction ·AESCULAP AG & CO. KG·Product code KRO·December 9, 2014

    ENDURO MENISCAL COMPONENT F2 10MM

    FDA Adverse Event
    Malfunction ·AESCULAP AG AND CO. KG·Product code KRO·January 14, 2015

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 20, 2013

    BELT CLIP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·September 26, 2014

    EON IMPLANTABLE PULSE GENERATOR

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 9, 2011

    1.5MM/2.0MM SCREWDRIVER BLADE WITH HOLDING SLEEVE, LONG

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code HXX·July 21, 2015

    PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code LPH·October 17, 2025

    ENDURO MENISCAL COMPONENT F1 10MM

    FDA Adverse Event
    Injury ·AESCULAP IMPLANT SYSTEMS·Product code KRO·October 11, 2016

    Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033, K172726, K201758, K033225, K183419.

    FDA Enforcement
    Class II ·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023

    Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033, K172726, K201758, K033225, K183419.

    FDA Recall
    Open, Classified ·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code EOQ·September 25, 2023

    Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO)

    FDA Enforcement
    Class II ·Ongoing·Isopure Corp·July 20, 2022