BEUDAMED
    13 results · 29ms · Sources: EU EUDAMED, US FDA

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    QUICKSCREEN BARBITURATE 300 SCREENING TEST, MODELS 9019, 9018; MULTI DRUG SCREENING TEST, MODEL 9317T; CUP MULTI DRUG SC

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Paltop

    FDA UDI
    PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290114694971·Final Drill for Ø6mm Implant, Long

    Paltop

    FDA UDI
    PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108696202·Final Drill for Ø6mm Implant, Long

    MODIFICATION TO CAVERMAP SURGICAL AID

    FDA 510(k)
    FDA Class 1 ·Gastroenterology, Urology

    SOFTLINE SPRING CLIP

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LUX 1440

    FDA Adverse Event
    Malfunction ·PALOMAR MEDICAL TECHNOLOGIES, INC.·Product code GEX·May 5, 2012

    SPECTRA WAVEWRITER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·September 19, 2024

    MAESTRO LARGE FIXED DURAGUARD

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code HBB·April 22, 2013

    CRYOSTORE EVA BAGS

    FDA Adverse Event
    Malfunction ·ORIGEN BIOMEDICAL, INC.·Product code KSR·April 21, 2011

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·July 3, 2008

    Welch Allyn Vital Signs Monitor 5300 Series 300 Part numbers 007-0098-00 through 007-0159-00

    FDA Recall
    Terminated ·Welch Allyn Protocol, Inc·Product code DQA·June 8, 2004

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015

    GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model/Catalog/Code Numbers: a)¿¿¿¿¿ 2089507-120; b)¿¿¿¿ 2089507-129; c)¿¿¿¿¿ 2089507-131; d)¿¿¿¿ 2089507-135; e)¿¿¿¿ 2089507-136; f)¿¿¿¿¿¿ 2089507-140; g)¿¿¿¿¿ 2089507-144; h)¿¿¿¿ 2089507-145; i)¿¿¿¿¿¿ 2089507-149; j)¿¿¿¿¿¿ 2089507-153; k)¿¿¿¿¿ 2089507-154; l)¿¿¿¿¿¿ 2089507-155; m)¿¿¿ 2089507-156; n)¿¿¿¿ 2089507-157; o)¿¿¿¿ K2037DAED; p)¿¿¿¿ K2037DBED; q)¿¿¿¿ K2037DED; r)¿¿¿¿¿ K2037DJED; s)¿¿¿¿¿ K2037DNED; t)¿¿¿¿¿ K2042TTED; u)¿¿¿¿ K2049DC; v)¿¿¿¿¿ K2049DD; w)¿¿¿ K2049DF; x)¿¿¿¿¿ P2037DAED; y)¿¿¿¿¿ P2037DBED; z)¿¿¿¿¿ P2037DED; aa)¿¿ To be provided

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare·October 16, 2024