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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    SNIPER, MODEL OR-3872XX SERIES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·H65810012511·K-FILES 21MM #80

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·10304040093945·Maxima K-Files 21mm

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092001251·artVeneer life lower anteriors, UCL, B3

    Health-Tec/DHP Hand Instruments

    FDA UDI
    Dental Health Products Inc·D77370012510·Health-Tec/DHP Excavator DE 17

    Silicone Tubing

    FDA UDI
    INVOTEC INTERNATIONAL, INC.·00818501023080·Silicone Tubing 0.188" X 0.375"

    ACCU-CHEK FLEXLINK

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·June 25, 2025

    SPECTRUM SILICONE FOLEY CATHETER

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

    RX EVEREST

    FDA 510(k)
    FDA Class 2 ·Dental

    AUTOMATIC ASPIRATOR/IRRIGATOR

    FDA Adverse Event
    Injury ·SITE MICROSURGICAL SYSTEMS, INC.·Product code HQC·March 28, 1994

    BD PLASTIPAK 50ML LUER-LOK SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·June 15, 2020

    ACCU-CHEK FLEXLINK PLUS INFUSION SET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·May 26, 2025

    MALTZMAN INTRAOCULAR IRRIGATION/ASPIRATION

    FDA Adverse Event
    Injury ·XOMED-TREACE·Product code HQC·March 28, 1994

    IMPAX CV REPORTING

    FDA Adverse Event
    Malfunction ·AGFA HEALTHCARE CORP.·Product code LLZ·February 26, 2013

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·February 24, 2011

    AMX 4

    FDA Adverse Event
    Malfunction ·GE MEDICAL SYSTEMS, LLC·Product code IZL·February 22, 2008

    Colonoscope: for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve). Model Numbers: CF-2T160I, CF-2T160L, CF-H170I, CF-H170L, CF-H180AI, CF-H180AL, CF-H180DI, CF-H180DL, CF-H190I, CF-H190L, CF-HQ190I, CF-HQ190L, CF-LV1I, CF-LV1L, CF-Q150I, CF-Q150L, CF-Q160S, CF-Q180AI, CF-Q180AL. 510(k) Numbers: K954451, K112680, K100584, K051645, K111756, K001241, K911278.

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

    Colonoscope: for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve). Model Numbers: CF-2T160I, CF-2T160L, CF-H170I, CF-H170L, CF-H180AI, CF-H180AL, CF-H180DI, CF-H180DL, CF-H190I, CF-H190L, CF-HQ190I, CF-HQ190L, CF-LV1I, CF-LV1L, CF-Q150I, CF-Q150L, CF-Q160S, CF-Q180AI, CF-Q180AL. 510(k) Numbers: K954451, K112680, K100584, K051645, K111756, K001241, K911278.

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

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018