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

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    DEPUY GLOBAL AP CTA HUMERAL HEAD

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LiteTouch

    FDA UDI
    RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD·00383730000770·LiteTouch Medium Mask, 10-pack.

    COATED VICRYL PLUS ANTIBACTERIAL SUTURE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code GAM·April 20, 2006

    COATED VICRYL PLUS ANTIBACTERIAL SUTURE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code GAM·April 20, 2006

    COATED VICRYL PLUS ANTIBACTERIAL SUTURE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code GAM·April 20, 2006

    COATED VICRYL PLUS ANTIBACTERIAL SUTURE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code GAM·April 20, 2006

    ECAT PET SCANNER

    FDA 510(k)
    FDA Class 2 ·Radiology

    HYGIA HEALTH SERVICES REPROCESSED NELLCOT D-25 OXISENSOR II

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SPECTRA WAVEWRITER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·January 10, 2025

    COATED VICRYL PLUS ANTIBACTERIAL SUTURE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code GAM·April 25, 2006

    COATED VICRYL PLUS ANTIBACTERIAL SUTURE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code GAM·April 21, 2006

    ASAHI REXEED-LX SERIES DIALYZER

    FDA Adverse Event
    Injury ·ASAHI KASEI MEDICAL CO., LTD.·Product code KDI·May 4, 2012

    Mach 4 Mouse Probe vial within the Mach 4 Universal HRP-Polymer Kit; Catalog number M4U534L; For In Vitro Use Immunology: MACH 4 Universal HRP-Polymer is a horseradish peroxidase (HRP)-antibody conjugate system intended for use in the detection of mouse lgG and lgM, and rabbit IgG primary antibodies on formalin-fixed, paraffin-embedded (FFPE) tissues in an immunohistochemistry (IHC) procedure. The clinical interpretation of any staining or its absence should be complemented by morphological studies and proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.

    FDA Enforcement
    Class III ·Terminated·Biocare Medical, LLC·April 27, 2016

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·April 29, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·April 27, 2011

    KNIGHTSTAR 330

    FDA Adverse Event
    Malfunction ·NELLCOR PURITAN BENNETT·Product code CBK·July 23, 2008

    Mach 4 Mouse Probe vial within the Mach 4 Universal HRP-Polymer Kit; Catalog number M4U534L; For In Vitro Use Immunology: MACH 4 Universal HRP-Polymer is a horseradish peroxidase (HRP)-antibody conjugate system intended for use in the detection of mouse lgG and lgM, and rabbit IgG primary antibodies on formalin-fixed, paraffin-embedded (FFPE) tissues in an immunohistochemistry (IHC) procedure. The clinical interpretation of any staining or its absence should be complemented by morphological studies and proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.

    FDA Recall
    Terminated ·Biocare Medical, LLC·Product code NJT·March 31, 2016

    Cocoon Convective Warming System, Product Code: CWS4000 (110V).

    FDA Enforcement
    Class II ·Terminated·Care Essentials Pty., Ltd.·February 12, 2020

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012