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

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    i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

    FDA Recall
    Open, Classified ·Abbott Point Of Care Inc.·Product code CHL·August 21, 2025

    i-STAT EG7+ cartridge. List Number: 03P76-25.

    FDA Recall
    Open, Classified ·Abbott Point Of Care Inc.·Product code CHL·August 21, 2025

    i-STAT EG6+ cartridge. List Number: 03P77-25.

    FDA Recall
    Open, Classified ·Abbott Point Of Care Inc.·Product code CHL·August 21, 2025

    VIDAS CLINICALVIDAS VARICEL. ZOSTER IGG 60 T, CATALOG 30217

    FDA Recall
    Open, Classified ·Biomerieux Inc·Product code LFY·November 9, 2022

    HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144

    FDA Recall
    Open, Classified ·Mizuho OSI·Product code LXH·July 29, 2021

    Mizuho CE IPX4, mode MOT-5602BW, 100-240, 50-60Hz, 400VA, REF 18-140-20 containing hand control Unit - Product Usage: intended to support a patient during surgical operations.

    FDA Recall
    Open, Classified ·Mizuho OSI·Product code GDC·February 8, 2021

    One Step P in vitro diagnostic test REF: 8194

    FDA Recall
    Open, Classified ·DFI Co., Ltd. 388-25 Gomo-Ro Jillye-Myeon Gimhae Korea (the Republic of)·Product code JIR·April 2, 2026

    One Step pH in vitro diagnostic test REF: 31I4P

    FDA Recall
    Open, Classified ·DFI Co., Ltd. 388-25 Gomo-Ro Jillye-Myeon Gimhae Korea (the Republic of)·Product code CEN·April 2, 2026

    QUCARE Total Cholesterol in vitro diagnostic test REF: 6407

    FDA Recall
    Open, Classified ·DFI Co., Ltd. 388-25 Gomo-Ro Jillye-Myeon Gimhae Korea (the Republic of)·Product code CHH·April 2, 2026

    Uric Acid in vitro diagnostic test REF: 31H0P

    FDA Recall
    Open, Classified ·DFI Co., Ltd. 388-25 Gomo-Ro Jillye-Myeon Gimhae Korea (the Republic of)·Product code KNK·April 2, 2026

    One Step UTI in vitro diagnostic test REF: 3374

    FDA Recall
    Open, Classified ·DFI Co., Ltd. 388-25 Gomo-Ro Jillye-Myeon Gimhae Korea (the Republic of)·Product code LJX·April 2, 2026

    One Step 10A in vitro diagnostic test

    FDA Recall
    Open, Classified ·DFI Co., Ltd. 388-25 Gomo-Ro Jillye-Myeon Gimhae Korea (the Republic of)·Product code MVO·April 2, 2026

    One Step K in vitro diagnostic test REF: 81A4

    FDA Recall
    Open, Classified ·DFI Co., Ltd. 388-25 Gomo-Ro Jillye-Myeon Gimhae Korea (the Republic of)·Product code JIN·April 2, 2026

    INDICAID COVID-19 Rapid Antigen At-Home Test, REF: P0040

    FDA Recall
    Open, Classified ·PHASE SCIENTIFIC INTERNATIONAL LIMITED 1/f, E Phase 3 Hong Kong Science Park Sha Tin Hong Kong SAR·Product code QMN·October 25, 2023

    UFSK Treatment chair 500 XLE- Treatment chair for positioning and support of the patient during diagnostic and therapeutic treatments of temporary to short-term duration, especially in ophthalmology Art.no. / REF no.: 15000004 Art.no. / REF no.: 15000006

    FDA Recall
    Open, Classified ·UFSK International OSYS Gmbh Kirchhoffstr. 1 Ratisbon Germany·Product code HME·May 31, 2023

    PENTAX Medical Video Colonoscope- Intended to provide optical visualization of (via a video monitor), and therapeutic access to the lower gastrointestinal tract Model: EC38-i20cL

    FDA Recall
    Open, Classified ·Pentax of America Inc·Product code PEA·January 29, 2025

    PENTAX Medical Video Upper GI Scope-Intended to provide optical visualization of (via a video monitor), and therapeutic access to the lower gastrointestinal tract Model: EG29-i20c

    FDA Recall
    Open, Classified ·Pentax of America Inc·Product code PEA·January 29, 2025

    Pentax Medical Video Processor- Intended to be used with PENTAX Medical endoscopes, monitors and other peripheral devices for endoscopic diagnosis, treatment, and video observation. Model: EPK-i8020c

    FDA Recall
    Open, Classified ·Pentax of America Inc·Product code PEA·January 29, 2025

    Pentax Medical Video Processor; Model Number: EPK-i8020c;

    FDA Recall
    Open, Classified ·Pentax of America Inc·Product code PEA·July 16, 2025

    Gastroscope Family # 1-Gastroscopes without a Water Jet Channel Models: EG-2790i, EG-1690K, EG-2490K, EG-2790K, EG27-i10; Gastroscope Family # 2- Gastroscopes with a Water Jet Channel Models: EG-2990i, EG-2990K, EG-3490K, EG29-i10; Gastroscope Family # 3-Gastroscopes with Two Instrument Channels and a Water Jet Channel Models: EG-3890TK

    FDA Recall
    Open, Classified ·Pentax of America Inc·Product code FDF·July 14, 2021