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

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    Bronchi and Gastrointestinal Cytology Brush

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

    Ophthalmic Ring

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100776·FLIERINGA FIXATION RING 16MM

    SPECTRA WAVEWRITER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 14, 2020

    ASA01 HEAVY DUTY SUCTION PUMP

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

    BIOMET 3I PATIENT SPECIFIC DENTAL ABUTMENTS - ENCODE ABUTMENTS

    FDA 510(k)
    FDA Class 2 ·Dental

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·October 14, 2014

    PFNA-II BLADE L100 TAN

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HSB·June 15, 2013

    OPTIFLOW JUNIOR INTERFACE

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code CAT·October 23, 2015

    INTELLIS

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·June 2, 2021

    BD SYRINGE 10ML LL S/C 200

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·November 21, 2023

    Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808

    FDA Enforcement
    Class II ·Ongoing·Philips North America·May 6, 2026

    CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-0105-03L c. 21-2120-0105-06L d. 21-2120-0105-07L e. 21-2120-0105-08L f. 21-2120-0105-12L g. 21-2120-0105-13L h. 21-2120-0105-14L i. 21-2120-0105-15L j. 21-2120-0105-17L k. 21-2120-0105-50L l. 21-2127-0105-02L m. 21-2127-0105-06L n. 21-2127-0105-50L

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD Inc.·October 27, 2021

    Panda Infant Radiant Warmer Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment or to provide a controlled open environment.

    FDA Enforcement
    Class I ·Terminated·GE Healthcare, LLC·July 17, 2019

    Panda iRes Infant Radiant Warmer. Device sold under the following product names: Panda iRes Warmer and Panda iRes Bedded Warmer.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·November 28, 2018

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018