BEUDAMED
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    iDesign, Model - G300: System AWS (International), System AWS (China), Advanced WaveScan Studio (United States); iDesign Refractive Studio Aberrometer (International) and (United States), Model: G301

    FDA Recall
    Open, Classified ·AMO Manufacturing USA, LLC·Product code LZS·October 21, 2021

    Babylog VN500 Ventilator with Installed CO2 Measurement Option-intended for the ventilation of neonatal patients from 0.4 kg (0.88 lbs) up to 10 kg (22 lbs) and pediatric patients from 5 kg (11 lbs) up to 20 kg (44 lbs) bodyweight. Catalog Number: 8417400

    FDA Recall
    Open, Classified ·Draeger Medical, Inc.·Product code CBK·September 10, 2021

    DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code JJE·May 22, 2024

    Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code JJE·May 22, 2024

    The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation line. UniCel DxI 600 Catalog Numbers: A30260, A71460, A71461, A92060. Unicel DxI 800 Catalog Numbers: 973100, A71456, A71457, A84545, A25288, A25285.

    FDA Recall
    Open, Classified ·Beckman Coulter Inc.·Product code JJE·December 5, 2018

    UniCel DxC 660i, 680i, 860i, and 880i SYNCHRON Access Clinical Systems, that are re-configured so that the DxI system is separated from the DxC system and the DxI instrument is then connected to an automation line. System Name/ Catalog Number: DxC 660i/ A64871, DxC 680i /A64903, DxC 860i /A64935, DxC 880i /A59102

    FDA Recall
    Open, Classified ·Beckman Coulter Inc.·Product code JJE·December 5, 2018

    Philips Laser System, REF LAS-100, Intermittent Operation, Duty cycle dependent upon device in use 100 - 240 VAC, 50/60HZ, 16 AM

    FDA Recall
    Open, Classified ·Spectranetics Corporation·Product code LPC·June 1, 2022

    Hill-Rom Progressa Bed System

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code FNL·October 18, 2022

    Altair 330 lbs w/o Hanger Bar, REF: 55200H-NA, 55220H-NA, and Roomer S 220 kg w/o Hanger Bar, REF: 55300H-NA, patient lifts

    FDA Recall
    Open, Classified ·Human Care Hc Sweden Ab Arstaangsvagen 21 B Stockholm Sweden·Product code FSA·February 23, 2024

    Philips Laser System, REF: LAS-100. Used in minimally invasive interventional procedures within the cardiovascular system, and for the removal of problematic pacemaker and defibrillator cardiac leads.

    FDA Recall
    Open, Classified ·Spectranetics Corporation·Product code LPC·October 14, 2022

    Philips, REF M5072A, INFANT/CHILD - SMART PADS CARTRIDGE (0-8 YEARS). Smart PADS CARTRIDGE , (0-8 YEARS) <55 lbs/25 kg, CE 0123, NON-STERILE, Rx only FOR USE WITH HEARSTART DEFIBRILLATORS

    FDA Recall
    Open, Classified ·Philips North America LLC·Product code MKJ·February 4, 2022

    ECONO STERILE medical procedure kits labeled as: ECONO STERILE" CURETTE EXCAVATOR STRL CS/25, Model Number 941-1320; general surgical

    FDA Recall
    Open, Classified ·Sklar Instruments·Product code FZS·December 3, 2024

    The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients weighing 60 lbs. or greater and having an abdominal thickness greater than 16 cm and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects.

    FDA Recall
    Open, Classified ·Medtronic Navigation, Inc.-Littleton·Product code OWB·July 25, 2023

    Osteosynthesis Compression Staple EasyClip

    FDA Recall
    Open, Classified ·Stryker GmbH Bohnackerweg 1 Selzach Switzerland·Product code JDR·September 25, 2020

    YelloPort Elite, REF: EO0507005, 5x70 Optical Trocar, , Rx Only, SterileR

    FDA Recall
    Open, Classified ·Surgical Innovations Ltd 6 Clayton Wood Bank Lds Leeds United Kingdom·Product code GCJ·March 28, 2023

    Brand Name: PERLA TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 55 45-S Software Version: Not Applicable Product Description: CANNULATED FENESTRATED POLYAXIAL SCREW

    FDA Recall
    Open, Classified ·SPINEART SA Chemin Du Pre-Fleuri 3 Plan-Les-Ouates Switzerland·Product code NKB·June 30, 2025

    JULIET Ti LL, LATERAL LUMBAR TI-LIFE PLATE SMALL, REF: JLT-PL 02 08-S, JLT-PL 02 10-S, JLT-PL 02 12-S, JLT-PL 02 14-S, JLT-PL 02 16-S; JULIET Ti LL, LATERAL LUMBAR TI-LIFE PLATE LARGE, REF: JLT-PL 04 08-S, JLT-PL 04 10-S, JLT-PL 04 12-S, JLT-PL 04 14-S, JLT-PL 04 16-S, JLT-PL 04 18-S

    FDA Recall
    Open, Classified ·SPINEART SA Chemin Du Pre-Fleuri 3 Plan-Les-Ouates Switzerland·Product code OVD·March 16, 2023

    Brand Name: TBS Osteo Product Name: TBS iNsight Model/Catalog Number: TBS iNsight v3.x / pn: OS-TBSi Software Version: V3.x: (1) V3.1.2, (2) V3.1.1, (3) V3.1.0, (4)V3.0.0 Product Description: TBS iNsight is a class II Medical Device software that is installed on bone densitometers for analysis of bone microarchitecture and bone health management Component: No

    FDA Recall
    Open, Classified ·Medimaps Group Fongit Chemin des Aulx 18 Plan-les-Ouates Switzerland·Product code KGI·February 3, 2025

    Product/Part: YelloPort Plus 5x70 Cannula + Luer/YC0507001. For use in laparoscopic procedures.

    FDA Recall
    Open, Classified ·Surgical Innovations Ltd 6 Clayton Wood Bank Lds Leeds United Kingdom·Product code GCJ·January 20, 2022

    YelloPort Elite, REF: EO0509505, 5x95 Optical Trocar, Rx Only, SterileR

    FDA Recall
    Open, Classified ·Surgical Innovations Ltd 6 Clayton Wood Bank Lds Leeds United Kingdom·Product code GCJ·March 28, 2023