BEUDAMED
    23 results · 20ms · 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 ×

    Powder Free Nitrile Examination Gloves, Blue and Violet Blue, Test For Use With Chemotherapy Drugs

    FDA 510(k)
    FDA Class 1 ·General Hospital

    LUMEX

    FDA UDI
    GF HEALTH PRODUCTS, INC.·M36882202281·W/C CUSHIONGEL/FOAM22x18x4

    Certi-Strips - Woven - Knuckle - 25/Box

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588202280·Certi-Strips - Woven - Knuckle - 25/Box

    Coral

    FDA UDI
    Seaspine Orthopedics Corporation·10889981029272·Fixed X-Conn 28mm

    Omron Model BP7900 Blood Pressure Monitor + EKG

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ClearCam System

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

    FLOWFLEX COVID-19 ANTIGEN HOME TEST

    FDA Adverse Event
    Malfunction ·ACON LABORATORIES, INC.·Product code QKP·June 8, 2023

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·November 3, 2014

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 23, 2011

    DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·July 11, 2013

    OT ULTRA METER

    FDA Adverse Event
    Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 16, 2014

    NEUTROGENA VISIBLY CLEAR LIGHT THERAPY SPOT TREATMENT

    FDA Adverse Event
    Injury ·JOHNSON & JOHNSON CONSUMER INC·Product code OLP·October 6, 2020

    BARD MAX-CORE Disposable Core Biopsy Instrument - Product Usage: The core needle biopsy device is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.

    FDA Enforcement
    Class II ·Terminated·Bard Peripheral Vascular Inc·January 1, 2020

    Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), REF PT-65509 (finished good kit) The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.

    FDA Enforcement
    Class I ·Terminated·TELEFLEX MEDICAL INC·February 23, 2022

    Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter Inc.·October 13, 2021

    Bard Conquest 40 PTA Dilation Catheter, 8mm X 20mm x 75cm (CQF7582), 8mm x 40mm x 75cm (CQF7584); Recommended Guidewire .035"; Recommended Introducer 6F; Nominal Pressure 8atm, Rated Burst Pressure 40atm; Syringe inflation 1cc; UDI: (01)00801741060533(17)220228(10)REDQ3444

    FDA Recall
    Terminated ·Bard Peripheral Vascular Inc·Product code LIT·August 14, 2019

    Bard Conquest 40 PTA Dilation Catheter, 8mm X 20mm x 75cm (CQF7582), 8mm x 40mm x 75cm (CQF7584); Recommended Guidewire .035"; Recommended Introducer 6F; Nominal Pressure 8atm, Rated Burst Pressure 40atm; Syringe inflation 1cc; UDI: (01)00801741060533(17)220228(10)REDQ3444

    FDA Enforcement
    Class II ·Terminated·Bard Peripheral Vascular Inc·February 5, 2020

    Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where minimizing blood loss is essential.

    FDA Enforcement
    Class II ·Terminated·Abbott Medical·January 15, 2020

    Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), PT-45509 containing components: PT-45509-S6, PT-45509-T The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.

    FDA Enforcement
    Class I ·Terminated·TELEFLEX MEDICAL INC·February 23, 2022

    Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-12709-WC, containing components: PT-12709-CA, PT-12709-C, The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.

    FDA Enforcement
    Class I ·Terminated·TELEFLEX MEDICAL INC·February 23, 2022