BEUDAMED
    78 results · 12ms · Sources: EU EUDAMED, US FDA

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    ARIES Extraction Kit; ARIES System; SYNCT , REF 50-10026, UDI # 00840487100073

    FDA Enforcement
    Class II ·Ongoing·Luminex Corporation·August 21, 2019

    YOUNG DH Dry Heat Indicators, PRESSURE SENSITIVE LABELS with COLOR INDICATOR STRIP, REF 116312 Intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process.

    FDA Enforcement
    Class II ·Ongoing·Young Dental Mfg Co I LLC·February 9, 2022

    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

    NeiMed NasoGel for DRY NOSES UDI-DI/UPC code: 00705928045309 SKU GSP30-2R-48-ENU-USL GSP30-0R-96-ENU-USL GSP30-ARA-INTL GSP30-SWE-INTL GSP30-ENG-INT GSP30-MAL-INTL GSP30-SPA-INT NasoGel Spray is a saline-based gel formula that can be sprayed to moisturize and lubricate dry and irritated anterior or front of nasal passages caused by dry climate and indoor heat.

    FDA Enforcement
    Class II ·Ongoing·Neilmed Pharmaceuticals Inc·February 12, 2025

    ARIES SARS-CoV-2 Assay

    FDA Enforcement
    Class II ·Ongoing·Luminex Corporation·August 24, 2022

    a. SporView Culture Set SporView Sterilization Biological Indicator Kit Steam / EO Gas / Dry Heat / Chemical Vapor Model Number: CS-020 b. SPORVIEW CULTURE SET SporView Sterilization Biological Indicator Kit Steam / EO Gas / Dry Heat / Chemical Vapor Model Number: CS-100

    FDA Enforcement
    Class III ·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·October 5, 2022

    Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DYN Sapphire, Model CD Sapphire, list number 08H00-01. Multi-parameter, automated hematology analyzer.

    FDA Enforcement
    Class II ·Ongoing·Abbott Laboratories·December 27, 2023

    Aries Bordetella Assay, REF 50-10037, UDI # 00840487101452

    FDA Enforcement
    Class II ·Ongoing·Luminex Corporation·August 21, 2019

    ARIES GBS Assay , REF 50-10021, UDI # 00840487100165

    FDA Enforcement
    Class II ·Ongoing·Luminex Corporation·August 21, 2019

    ARIES SARS-CoV-2 Assay, REF: 50-10047

    FDA Enforcement
    Class II ·Ongoing·Luminex Corporation·November 2, 2022

    MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·April 15, 2026

    ARIES C. difficile Assay , REF 50-10018, UDI # 00840487100059

    FDA Enforcement
    Class II ·Ongoing·Luminex Corporation·August 21, 2019

    ARIES HSV 1&2 Assay , REF 50-10017, UDI # 00840487100295

    FDA Enforcement
    Class II ·Ongoing·Luminex Corporation·August 21, 2019

    ARIES Group A Strep Assay , REF 50-10041, UDI # 00840487101469

    FDA Enforcement
    Class II ·Ongoing·Luminex Corporation·August 21, 2019

    Express Mini 500 Dry Seal Chest Drain, Part Number 16400

    FDA Enforcement
    Class II ·Ongoing·Atrium Medical Corporation·April 5, 2023

    Citric Complete - Dry Citric Acid Concentrate Model Number: DCA+225-25

    FDA Enforcement
    Class II ·Ongoing·Nipro Renal Soultions USA, Corporation·January 15, 2025

    Brand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 Product Name: Olympus GIF-1TH190 Model/Catalog Number: GIF-1TH190 Software Version: N/A Product Description: This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·November 27, 2024

    DuoDERM" Extra Thin dressings are highly flexible, control gel formula dressings designed for use on dry to lightly exudating wounds. DuoDERM" Extra Thin dressings are particularly suitable in areas subject to friction and those requiring contouring, e.g., elbows, heels. DuoDERM" Extra Thin dressings interact with wound moisture producing a soft mass that enables removal of the dressing with little or no damage to newly formed tissues. They help isolate the wound against bacterial and other external contamination. INDICATIONS " Management of superficial, dry to lightly exudating dermal ulcers. " Post-operative wounds. " Protective dressings.

    FDA Enforcement
    Class II ·Ongoing·ConvaTec, Inc·October 22, 2025

    Spiros CLOSED MALE LUER w/RED CAP, 25 UNITS, REF: 011-CH2000SC-25; 76 cm (30") Appx 3.2 ml, 20 Drop Admin Set w/Integrated ChemoClave Drip Chamber, Spiros w/Purple Cap, Bag Hanger, REF: 011-CH3185; 46 cm (18") Appx 7.4 ml, Trifuse Add-On Set w/2 Spiros w/Purple Caps, Bag Spike, 3 Clamps (Blue, 2 Red), Dry Spike Adapter, REF: 011-CH3266; 76 cm (30") Appx 3.3 ml, Admin Set, 2 Spiros w/Purple Cap, 20 Drop In-Line Drip Chamber, Bag Hanger, REF: 011-CH3446; 61 cm (24") Appx 8.2 ml, Bifuse Add-On Set w/Bag Spike, Spiros w/Purple Cap, 3 Clamps (1 Blue, 2 White), Check Valve, Dry Spike Adapter, REF: 011-CH3729; 25 UNITS of Spiros CLOSED MALE LUER, REF: 011-H2457; Appx 1.0 ml, Adattatore per Pompa con Spiros, REF: 011-H2629; 179 cm (70") Appx 11.5 ml, PUR Ambr. Deflussore con Spiros, Camera, BCV, Y-Clave e LL Gir., REF: 011-H2776; 180 cm (71IN)APPX 11.5ml,PUR AMBR,Spiros,CAMERA,REG.FLUSSO,BCV,Y-Clave, REF: 011-H2864-HSR; 181cm(71 IN)APPX11.6ml,PUR DEFLUSSORE,Spiros,20 DROP IN LINE,BCV,Clave, REF: 011-H2904; 38 cm (15 IN) APPX 2.9 ml, TRIFUSE EXT SET, 3 MicroClave, Spiros, PURPLE CAP, REF: 011-H3449; 42cm(16.5 IN)APPX 2.6ml,PUR TRANSFER SET,Clave ADDITIVE PORT,BCV,Spiros, REF: 011-H3597; 41cm(16 IN)APPX 2.9ml,PUR SET PERFORATORE,Clave,VALVOLA,Spiros, REF: 011-H3628; 41cm(16 IN)APPX 3.1ml,SET AMBRATO,PERFORATORE,Clave,VALVOLA,Spiros, REF: 011-H3629; 42cm(16.5 IN)APPX 5.6ml,SET,PERFORATORE,Clave,FILTRO,VALVOLA,Spiros, REF: 011-H3630; 109 cm(43 IN) APPX 7.2 ml,KIT,EXT SET W/Spiros,STOPCOCK,5 Clave,4-GANG STOPCOCK, REF: 011-MC330632; 2 Ext Sets w/5-Gang Stopcock, 9 Clave, Spiros, Stopcock, REF: 011-MC33242; Kit for multiple transfers, REF: 011-N1000; Kit per il riempimento pompe elastomeriche con SPIROS / Kit for elastomeric pump priming with SPIROS, REF: 011-N1000-P2; APPX 2.3ml, ZYTO-VERBINDUNGSLEITUNG (ZYTO-CONNECTING LINE), REF: 011-N1664SP; Appx 1.0 ml, Adaptador universal para sistemas IV con Spiros, REF: 034-H2629; Spinning Spiros Closed Male Luer, Red Cap (No Flange), REF: CH2000S-NR; 15" (38 cm) Appx 5.2 ml, Bifuse Add-On Set w/Bag Spike, Spiros, 3 Clamps (Blue, 2 White), Dry Spike Adapter, REF: CH3187; 14" (36 cm) Appx 8.0 ml, Quinfuse Add-On Set w/4 Spiros, Bag Spike, 5 Clamps (Blue, 4 Red), Dry Spike Adapter, REF: CH3225; 20" (51 cm) Appx 9.5 ml, Quadfuse Add-On Set w/3 Spiros, Bag Spike, 4 Clamps (Blue, 3 Red), Dry Spike Adapter, REF: CH3226; 16" (41 cm) Appx 6.3 ml, Trifuse Add-On Set w/2 Spiros, Bag Spike, 3 Clamps (Blue, 2 Red), Dry Spike Adapter, REF: CH3227; 30" (76 cm) Appx 4.1 ml, Yellow 20 Drop Admin Set w/15 Micron Filter, Spiros, REF: CH3235; 28" (71 cm) Appx 5.1 ml, Add On Set w/Clave Spike, Spiros, Clamp, REF: CH3354; 16cm(6 IN)APPX 2.4ml,SET,MicroClave Clear,STOPCOCK,DROP-IN ADD-ON,Spiros, REF CH3411: APPX 1.9 ml,13 cm (5 IN),BAG SPIKE,Spiros,ACCESS DEVICE w/Clave, REF: CH3502; 60 (152 cm) Appx 1.9 ml, Smallbore Ext Set w/MicroClave Clear, 0.2 Micron Low Protein Binding Filter, Spiros w/Red Cap, Clamp, REF: CH3603; Spinning Spiros Closed Male Luer, REF: K7040-001; APPX 0.76ml, 4-WAY STOPCOCK w/2 Clave, VIAL ADAPTER, 3 Spiros, REF: K7052-001; ZYTOmed Verab.-Set Onko II lichtschutz, REF: SN1205AG; ZYTOmed - Verabreichungs-Set Onko III lichtgesch¿tzt, REF: SN1206A; Conector macho cerrado Spinning Spiros, tapon purpura, REF: 034-CH2000S-PC

    FDA Enforcement
    Class II ·Ongoing·ICU Medical, Inc.·December 30, 2020

    ARIES Flu A/B & RSV Assay , REF 50-10020, UDI # 00840487100158

    FDA Enforcement
    Class II ·Ongoing·Luminex Corporation·August 21, 2019