BEUDAMED
    2,418 results · 29ms · 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 ×

    HERCULES 100 3 STAGE WIRE GUIDED BALLOON

    FDA Adverse Event
    Injury ·COOK ENDOSCOPY·Product code KCF·March 2, 2021

    HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC

    FDA Adverse Event
    Malfunction ·COOK ENDOSCOPY·Product code KCF·June 9, 2021

    FLEXOR RTPS GUIDING SHEATH

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·June 24, 2019

    HERCULES 100 3 STAGE WIRE GUIDED BALLOON

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code KCF·February 28, 2024

    FLEXOR ANSEL GUIDING SHEATH

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·October 23, 2023

    BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·MICROVASIVE ENDOSCOPY DIV. BOSTON SCIENTIFIC CORP.·Product code KCF·January 20, 1995

    BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·MICROVASIVE ENDOSCOPY DIV. BOSTON SCIENTIFIC CORP.·Product code KCF·January 20, 1995

    SAVOY DILATOR

    FDA Adverse Event
    Injury ·WILSON COOK·Product code KCF·July 21, 1994

    MALONEY DILATORS

    FDA Adverse Event
    Injury ·MEDOVATIONS·Product code KCF·July 21, 1994

    HERCULES 100 3 STAGE WIRE GUIDED BALLOON

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code KCF·April 27, 2023

    INFINITY

    FDA Adverse Event
    Injury ·HOPE MEDICAL·Product code KCF·December 13, 2023

    CRE STERIFLATE DISPOSABLE INFLATION DEVICE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KCF·February 1, 2019

    COOK ESOPHAGEAL DILATOR SET

    FDA Adverse Event
    Injury ·COOK INC.·Product code KCF·December 29, 1998

    CRE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KCF·May 3, 2016

    COOK BALLOON COOK HERCULES 3 STAGE

    FDA Adverse Event
    Malfunction ·COOK ENDOSCOPY·Product code KCF·September 12, 2019

    Dilator, Esophageal, Ent

    FDA classification
    FDA Class 1 ·Dilator, Esophageal, Ent

    Hudson RCI Sheridan: 1) CF 6.0 mm, Product Codes: 5-10112, 5-10212 2) CF 6.5 mm, Product Codes: 5-10113, 5-10213 3) CF 7.0 mm, Product Codes: 5-10114, 5-10214 4) CF 7.5 mm, Product Codes: V5-10115, 5-10115, 5-10215 5) CF 8.0 mm, Product Codes: 5-10116, 5-10216, V5-10116 6) CF 8.5 mm, Product Codes: 5-10117, 5-10217 Product Usage: Tracheal tube/airway management

    FDA Recall
    Terminated ·Teleflex Medical·Product code BTR·May 24, 2019

    Hudson RCI Sheridan: 1) CF 6.0 mm, Product Codes: 5-10112, 5-10212 2) CF 6.5 mm, Product Codes: 5-10113, 5-10213 3) CF 7.0 mm, Product Codes: 5-10114, 5-10214 4) CF 7.5 mm, Product Codes: V5-10115, 5-10115, 5-10215 5) CF 8.0 mm, Product Codes: 5-10116, 5-10216, V5-10116 6) CF 8.5 mm, Product Codes: 5-10117, 5-10217 Product Usage: Tracheal tube/airway management

    FDA Enforcement
    Class I ·Terminated·Teleflex Medical·June 26, 2019

    KCI Manufacturing

    FDA registration
    KCI Manufacturing·3 products·🇮🇪 Ireland

    ZOLL-DENTAL

    FDA UDI
    Zoll-Dental·00840105203612·LT-2CF