BEUDAMED
    21 results · 20ms · Sources: EU EUDAMED, US FDA

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    Filters FDA Recall × Status: Completed × Clear all

    SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO

    FDA Recall
    Completed ·SynCardia Systems LLC·Product code LOZ·August 1, 2023

    Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug delivery device

    FDA Recall
    Completed ·Boston Scientific Corporation·Product code LKK·May 11, 2026

    Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC015/20, Sterile EO, UDI: (01)00630094430157

    FDA Recall
    Completed ·Bioseal Corporation·Product code KDD·March 23, 2021

    Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC009/20, Sterile EO, Single Use Only, UDI: (01)00630094430096

    FDA Recall
    Completed ·Bioseal Corporation·Product code KDD·March 23, 2021

    Bioseal, Chest Tube Insertion Tray, containing ChloraPREP Applicator 3 mL, REF: CHT017/20, Sterile EO, Single Use Only, UDI: (01)10630094820177

    FDA Recall
    Completed ·Bioseal Corporation·Product code KDD·March 23, 2021

    Energy FX: a) original Aluminum (100-3A) b) sleek (adult and kid & pet) (100-3B)

    FDA Recall
    Completed ·Basic Reset Inc.·Product code N/A·October 18, 2019

    ImmunoPass , COVID-19 Neutralizing Antibody Test, NAB 900-60

    FDA Recall
    Completed ·Empowered Diagnostics LLC·Product code QKO·December 22, 2021

    CovClear COVID-19 Rapid Antigen Test, ATG 900-031

    FDA Recall
    Completed ·Empowered Diagnostics LLC·Product code QKP·December 22, 2021

    Immundiagnostik IDK Lactoferrin ELISA- In vitro enzyme immunoassay intended for the determination of lactoferrin in stool. P/N: K6870 Single Kit P/N: K6870.20.US.L 20 Plates

    FDA Recall
    Completed ·IMMUNDIAGNOSTIK, Inc·Product code DEG·March 27, 2023

    NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service software

    FDA Recall
    Completed ·Illumina, Inc.·Product code PFF·April 5, 2023

    MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software.

    FDA Recall
    Completed ·Illumina, Inc.·Product code PFF·April 5, 2023

    REF 130-03-738, All-Poly e + Patella, Domed Tri-Peg, 9x38mm, STERILE H2O2

    FDA Recall
    Completed ·Product code PHX·October 5, 2023

    Reverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32mm, Semi-Constrained, Sterile H2o2, CE 2797

    FDA Recall
    Completed ·Product code PHX·October 5, 2023

    Outer Packaging Label: Protekt Sharps Safety Knives - REF: PG 44620MU, Sterile R, Multi-Use 2.2mm Double Bevel Slit, Angled 6 units, Individual Packaging Label: ProTekt Sharps Safety Knives - REF: PG 44620MU,2.2mm double Bevel Slit, Sterile R, Angled 1 unit, Handle Labeling; 2.5mm slit double bevel

    FDA Recall
    Completed ·International Science & Technology, LP, DBA Diamatrix Ltd.·Product code HNN·February 24, 2022

    Illumina NextSeq 550Dx, REF: 20005715, CE, IVD

    FDA Recall
    Completed ·Illumina, Inc.·Product code PFF·February 22, 2022

    Philips Affiniti 70, Diagnostic Ultrasound System Model # 795210

    FDA Recall
    Completed ·Philips Ultrasound, Inc.·Product code IYN·October 9, 2023

    Philips EPIQ Diagnostic Ultrasound System Models: EPIQ 7G(model # 795200), EPIQ 7C (Model # 795201), EPIQ 7W (Model # 795202), EPIQ 5G (model # 795204), EPIQ 5W (model # 795206), EPIQ CVx (Model # 795231), EPIQ Elite (model # 795234)

    FDA Recall
    Completed ·Philips Ultrasound, Inc.·Product code IYN·October 9, 2023

    Imperative Care, ZOOM 71 Reperfusion Catheter, REF: ICRC071137, TRX Tip, 137 cm, 6F (.083 in/2.11 mm), .071 in/1.8 mm), STERILE.EO, Rx Only, UDI: (01) 00812212030191. For neurovascular procedures.

    FDA Recall
    Completed ·IMPERATIVE CARE INC·Product code NRY·August 13, 2021

    Obalon Balloon System with Model 4300 Touch Dispenser Touchscreen; Software version 02.00.00.0076 - Product Usage: The System is intended to be used as an adjunct to a moderate intensity diet and behavior modification program. All balloons must be removed 6 months after the first balloon is placed. The Obalon Balloons are administered using the Navigation System.

    FDA Recall
    Completed ·Obalon Therapeutics Inc·Product code LTI·May 23, 2019

    Leccurate SARS-CoV-2, Antigen Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. for the qualitative detection of antigen SARS-CoV-2 in clinical samples (nasal swab).

    FDA Recall
    Completed ·LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD Building 7-1 NO. 37 Chaoqian Rd; Changping Tech Zone Beijing China·Product code QKP·April 26, 2021