BEUDAMED
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    Gelsoft Plus, REF: 635024PE, 631514PE, 631222PE, 633008PE, 633010PE, 633007PE, 636010PE, 632522PE, 633012PE, 635018PE, 631516PE, 636016PE, 631220PE, 631608PE, 631206PE, 631407P50E, 631508PE, 636008PE, 636006PE, 632518PE, 634008PE, 634006PE, 631218PE, 632211PE, 634007PE, 633006PE, 631506PE, 632524PE, 636007PE, 631512PE, 636012PE, 636014PE, 632211P50E, 633016PE, 631407PE, 631809PE, 632010PE, 631608P50E, 632520PE, 632412PE, 631510PE, 635022PE, 631224PE, 632412P50E, 631507PE, 633014PE, 632010P50E, 635020PE, 631809P50E. Gelweave, REF: 736038E, 736036E, 736034E, 736032ST/10DE, 736032E, 736030ST/10DE, 736030E, 736028ST/10DE, 736028E, 736026ST/10DE, 736026E, 736024ST/10DE, 736024E, 736022ST/10DE, 736022E, 736020E, 736018E, 736016E, 736014E, 736012E, 736010E, 736008E, 736006E, 735034ST/8AE, 735034/8RME, 735034/10SEE, 735034/10RME, 735032STE, 735032ST/8AE, 735032/8SE, 735032/8RME, 735032/10SEE, 735032/10RME, 735030STE, 735030ST/8AE, 735030/8SE, 735030/8RME, 735030/10SEE, 735030/10RME, 735028STE, 735028ST/8AE, 735028E, 735028/8SE, 735028/8RME, 735028/10RME, 735026STE, 735026ST/8AE, 735026E, 735026/8SE, 735026/8RME, 735026/10RME, 735024STE, 735024ST/8AE, 735024E, 735024/8SE, 735024/8RME, 735024/10SEE, 735024/10RME, 735022STE, 735022E, 735022/8SE, 735022/8RME, 735020E, 735020/8RME, 735018E, 734038E, 734036E, 734034E, 734034CX4RMSE, 734034/8E, 734034/10E, 734032E, 734032CX4RMSE, 734032/8E, 734032/10E, 734030E, 734030CX4RMSE, 734030/8E, 734030/10E, 734028CX4RMSE, 734028/8E, 734028/10E, 734026CX4RMSE, 734026/8E, 734026/10E, 734024CX4RMSE, 734024/8E, 734024/10E, 734022CX4RMSE, 734022/8E, 734022/10E, 734020CX4RMSE, 734020/8E, 734020/10E, 734018/8E, 73341088E, 73341088/8RME, 73341088/8E, 73341088/10RME, 73341088/10E, 73321488/8ARME, 7332148/10RMFE, 7332148/10RMEE, 733212810/10STDE, 7332128/10RMFE, 7332128/10RMEE, 73321088E, 73321088/8SDE, 73321088/8RME, 73321088/8E, 73321088/10RME, 73321088/10E, 7330888/8E, 7330668/6E, 733038E, 733036E, 733034E, 733032E, 733030E, 733028E, 733026E, 733024E, 733024/6AE, 733022E, 733022/6AE, 733020E, 733020/6AE, 733018E, 733018/6AE, 733016E, 733014E, 73301488/8ARME, 7330148/10RMFE, 7330148/10RMEE, 73301412/10ETE, 733012E, 733012810/10STDE, 7330128/10RMFE, 7330128/10RMEE, 733010E, 73301088E, 73301088/8SDE, 73301088/8RME, 73301088/8E, 73301088/10RME, 73301088/10E, 733010108/8S4E, 733010108/8RME, 733010/10RME, 733008E, 733006E, 7328888/8E, 7328668/6E, 73281488/8ARME, 7328148/10RMEE, 73281412/10ETE, 73281288/8E, 732812810/10STDE, 7328128/10RMFE, 7328128/10RMEE, 73281088E, 73281088/8SDE, 73281088/8RME, 73281088/8E, 73281088/10RME, 73281088/10E, 732810108/8S4E, 7326888/8E, 7326668/6E, 73261488/8ARME, 7326148/10RMEE, 732612810/10STDE, 7326128/10RMFE, 7326128/10RMEE, 73261088E, 73261088/8SDE, 73261088/8RME, 73261088/8E, 73261088/10RME, 73261088/10E, 732610108/8S4E, 732610/10RME, 732528E, 732526E, 732524E, 732522E, 732520E, 732518E, 7324888/8E, 7324668/6E, 73241488/8ARME, 7324148/10RMEE, 732412E, 732412810/10STDE, 7324128/10RMEE, 732412/6E, 73241088E, 73241088/8SDE, 73241088/8RME, 73241088/8E, 73241088/10RME, 73241088/10E, 732410108/8S4E, 73221488/8ARME, 732214/10/10CRME, 732212810/10STDE, 732212/10/8CRME, 732212/10/8ARME, 732211E, 73221088/8RME, 73221088/8E, 73221088/10E, 732210108/8S4E, 7320888/8E, 7320668/6E, 732038E, 732034E, 732034CX4RME, 732034/8E, 732034/10E, 732032E, 732032CX4RME, 732032/8E, 732032/10E, 732030E, 732030CX4RME, 732030/8E, 732030/10E, 732028CX4RME, 732028/8E, 732028/10E, 732026CX4RME, 732026/8E, 732026/10E, 732024CX4RME, 732024/8E, 732024/10E, 732022/10E, 732014/8X2E, 732014/8X2AE, 732014/10X2E, 732014/10X2AE, 732012810/10STDE, 732012/8X2E, 732012/8X2AE, 732012/10X2E, 732010E, 73201088/8RME, 73201088/8E, 732010108/8S4E, 732010/6E, 731809E, 731809/6E, 731608XL55E, 731608E, 731608/8/10RME, 731608/6E, 731608/10/10RME, 731516E, 731514E, 731512E, 731510E, 731508E, 731506E, 7314108/10RME, 731407XL55E,

    FDA Enforcement
    Class II ·Ongoing·Vascutek, Ltd.·March 11, 2026

    Brand Name: Valeda Light Delivery System Product Name: Light Based Device for Dry Age Related Macular Degeneration Product Description: Light Based Device for Dry Age Related Macular Degeneration Component: No

    FDA Enforcement
    Class III ·Ongoing·LUMITHERA INC·July 9, 2025

    Biological Age & Longevity Test

    FDA Enforcement
    Class II ·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025

    Firefly Floorsitter, Firefly Splashy Bathseat, Firefly GoTo Seat - Product Usage: The Splashy Bath-Seat is a Portable bath seat for children aged 1-8, The GoTo Seat is a light-weight, portable, postural support seat for kids, aged between 1 and 8 with disabilities.

    FDA Enforcement
    Class II ·Ongoing·James Leckey Design Ltd·April 15, 2020

    Medline convenience kits: ADD-A-CATH ARTERIAL INSERTION ARTNC185 PED SCHOOL AGE PICC DRSG TRAY DYNDC3291

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·June 24, 2026

    Blazer Open-Irrigated Ablation Batch Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF) Controller and Irrigation Pump, are indicated for: Cardiac electrophysiological mapping Delivering diagnostic pacing stimuli RF ablation of sustained or recurrent type 1 Atrial Flutter in patients age 18 years or older Treatment of drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation (PAF) in patients age 18 years or older, when used with a compatible mapping system

    FDA Enforcement
    Class III ·Ongoing·Boston Scientific Corporation·January 16, 2019

    IntellaTip MiFi Open-Irrigated Ablation Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF) Controller and Irrigation Pump, are indicated for: Cardiac electrophysiological mapping Delivering diagnostic pacing stimuli RF ablation of sustained or recurrent type 1 Atrial Flutter in patients age 18 years or older Treatment of drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation (PAF) in patients age 18 years or older, when used with a compatible mapping system

    FDA Enforcement
    Class III ·Ongoing·Boston Scientific Corporation·January 16, 2019

    IntellaNav MiFi Open-Irrigated Ablation Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF) Controller and Irrigation Pump, are indicated for: Cardiac electrophysiological mapping Delivering diagnostic pacing stimuli RF ablation of sustained or recurrent type 1 Atrial Flutter in patients age 18 years or older Treatment of drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation (PAF) in patients age 18 years or older, when used with a compatible mapping system

    FDA Enforcement
    Class III ·Ongoing·Boston Scientific Corporation·January 16, 2019

    CF Delivery Dev Caps Bravo x5, FGS-0635/FGS 0636 - Product Usage: intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age.

    FDA Enforcement
    Class II ·Ongoing·Covidien Llc·April 7, 2021

    BRAVO PH CAPS DELIVERY DEV5-PK, FGS-0312/FGS-0313 - Product Usage: intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age.

    FDA Enforcement
    Class II ·Ongoing·Covidien Llc·April 7, 2021

    Braun ThermoScan PRO 6000 Ear Thermometer-indicated for the intermittent measurement of human body temperature for patients having ages ranging from normal weight (full term) newborn to geriatric adults in a professional use environment. Model: 6000

    FDA Enforcement
    Class II ·Ongoing·Welch Allyn Inc·September 22, 2021

    Introducer Kit- Tearaway MicroSlide REF KIT-051-01, 00841268106130 INT-101-15, 00841268107380 These introducers are used for the procedures to introduce catheters and other intravascular devices into the coronary and peripheral vasculature of adult and pediatric patients of all ages.

    FDA Enforcement
    Class II ·Ongoing·Galt Medical Corporation·May 14, 2025

    ellacor System with Micro-Coring Technology-Indicated for use by medical professionals for the treatment of moderate and severe wrinkles in the mid and lower face in adults aged 22 years or older with Fitzpatrick skin types I-IV. Model #: Gen 4

    FDA Enforcement
    Class II ·Ongoing·Cytrellis Biosystems, Inc.·August 16, 2023

    The 4Kscore Test is an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total PSA (prostate specific antigen), Roche Elecsys free PSA, intact PSA, and human kallikrein 2) into a single numerical score that also incorporates the following information: a patients age, previous biopsy, and digital rectal exam (DRE). Patients file (sample type, prior biopsy status, DRE status and age) are uploaded to the Specimen Processing Module (SPM). The results from the four assays are exported automatically to Lab Manager Application (B2 LIS) which automatically triggers the 4Kscore calculation when values of the four analytes are available. The 4Kscore test results are determined automatically by the validated laboratory information system algorithm calculation software.

    FDA Enforcement
    Class II ·Ongoing·BioReference Health, LLC·June 14, 2023

    Myosa for Kids KS1 REF MyOSAKS1_Sb/Sp/Mb/Mp/Lb/Lc KS2 REF MyOSAKS2_Sb/Sc/Mb/Mc/Mp/Lb/Lc Myosa for Kids is a mouthguard in 3 different sizes (sm, med, lg) that can be used in children ages 3-15 to address breathing and myofunctional disorders. Catalog Numbers:

    FDA Enforcement
    Class II ·Ongoing·Myofunctional Research Company USA·December 24, 2025

    LIFEPAK CR2 Part / Catalog Numbers / UDI-DI code: CR2-2-001451 99512-001434 883873785911 LIFEPAK CR2: The LIFEPAK CR2 defibrillator is indicated for use on patients 1 year of age or older in cardiopulmonary arrest. The patient must be unresponsive (unconscious), not breathing normally, and showing no signs of circulation (for example, no pulse, no coughing, or no movement). The cprCOACHTM Feedback Technology in the LIFEPAK CR2 defibrillator is indicated for use on cardiopulmonary arrest patients and provides CPR guidance in accordance with the AHA Guidelines for patients 1 year of age or older. The LIFEPAK CR2 defibrillator is intended for use by personnel who have been trained in its operation. Users should have received training in basic life support/AED, advanced life support, or a physician-authorized emergency medical response training program.

    FDA Enforcement
    Class II ·Ongoing·Physio-Control, Inc.·September 10, 2025

    SystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, REMstar SE Auto Noncontinuous Ventilators The Philips Respironics E30 ventilator is intended to provide invasive and non-invasive ventilatory support for individuals with Respiratory Insufficiency. It is specifically for the care of adult and pediatric patients >7 years of age and >18kgs.

    FDA Enforcement
    Class I ·Ongoing·Philips Respironics, Inc.·July 21, 2021

    MiniMed 630G with SmartGuard, insulin pump, Ref/Model # MMT-1754K, MMT-1714K, MMT-1755K - Product Usage: intended for continuous delivery of basal insulin (at user selectable rates) and administration of insulin boluses (in user selectable amounts) for the management of diabetes mellitus in persons, fourteen years of age and older, requiring insulin.

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·December 9, 2020

    Philips Respironics E30 with Humidifier, Continuous Ventilator, Minimum Ventilatory Support, Facility Use; Product Numbers DSX9999H11, INX9999H19, RINX9999H19 The Philips Respironics E30 ventilator is intended to provide invasive and non-invasive ventilatory support for individuals with Respiratory Insufficiency. It is specifically for the care of adult and pediatric patients >7 years of age and >18kgs.

    FDA Enforcement
    Class I ·Ongoing·Philips Respironics, Inc.·July 21, 2021

    Embrace2- Indicated for use as an adjunct to seizure monitoring of adults and children age 6 and up in home or healthcare facilities during periods of rest. Models: (1) Flamingo Pink EM2-FP-S; (2) Sky Blue EM2-SB-2; (3) Seoul Grey EM2-SG-S; (4) Boston Blue EM2-BB-S; (5) Milan Black EM2-MB-S

    FDA Enforcement
    Class II ·Ongoing·EMPATICA SRL·November 1, 2023