BEUDAMED
    198 results · 6ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Ongoing × Clear all

    Veran : Endobronchial Models: INS-5500 View Optical Probe INS-5450 SPiN Xtend¿ 21ga, 1.8 OD, 5/Bx INS-5440 View Peripheral Catheter, 3.8mm OD, 2.5mm WC INS-5411 0.016" Stylet, 1235 mm L, 10/Bx INS-5410 SPiN Flex¿ ANSO¿ Needle, 22ga, 1.8mm OD, 5/Bx INS-5323 Sliding stopper INS-5300 "Always-On Tip Tracked¿ Triple Needle Brush, 12mm L, 1.8mm OD, 5/Bx"

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·October 11, 2023

    The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of the Rapid fFN Specimen Collection kit (PN: 71738-001). The Collection Tube (PN: 71550-001) is manufactured by a third-party supplier, MML Diagnostics Packaging, and includes the transport tube, cap, and extraction buffer. Tubes are packaged into PN: 71738-00 at Hologic prior to kit release.

    FDA Enforcement
    Class II ·Ongoing·Hologic, Inc.·February 12, 2025

    Burlington Medical, Kilt

    FDA Enforcement
    Class II ·Ongoing·Burlington Medical, LLC·April 8, 2026

    Burlington Medical, Wrap Aprons.

    FDA Enforcement
    Class II ·Ongoing·Burlington Medical, LLC·April 8, 2026

    Burlington Medical, Vest

    FDA Enforcement
    Class II ·Ongoing·Burlington Medical, LLC·April 8, 2026

    Burlington Medical, Frontal Aprons

    FDA Enforcement
    Class II ·Ongoing·Burlington Medical, LLC·April 8, 2026

    Syringes with Low Dead Space labeled as: a) SOL-M 1ml Slip Tip Syringe w/o needle (low dead space), Model No. 180011LDS, UPC 840368511899; b) SOL-M 1ml Slip Tip Syringe w/o needle (low dead space), Model No. P180011LDS, UPC 810018097554; c) SOL-M 1ml Luer Lock Syringe w/Exch Needle 23G*1" (low dead space), Model No. 181023L, UPC Sold in Canada Only; d) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 25G*5/8" low dead space), Model No. 12558LDS, UPC 810062435319; e) SOL-M 1ml Luer Lock Syringe w/o Needle (PP) (low dead space), Model No. P180001PP, UPC 818392018165; f) SOL-M 1ml TB Slip Tip Syringe w/Exch Needle 25G*5/8'' (low dead space), Model No. 181025S, UPC Sold in Canada Only

    FDA Enforcement
    Class II ·Ongoing·Sol-Millennium Medical Inc.·September 18, 2024

    Medicina Oral Tip Syringe 1ml Code: OT01

    FDA Enforcement
    Class II ·Ongoing·Medicina Uk Ltd·October 26, 2022

    Medicina Reusable Oral syringe 1ml Code: OTH01

    FDA Enforcement
    Class II ·Ongoing·Medicina Uk Ltd·October 26, 2022

    Medicina ENFit 1ml Reusable Low Dose Enteral Syringe Code: LHE01LD

    FDA Enforcement
    Class II ·Ongoing·Medicina Uk Ltd·October 26, 2022

    Cardinal Health Monoject Tuberculin Syringe, 1 mL Luer Lock, Catalog Number 1180100777

    FDA Enforcement
    Class II ·Ongoing·Cardinal Health 200, LLC·April 8, 2026

    1ml of DTT in liquid phase, in PET tube with capture cap, in bulk

    FDA Enforcement
    Class II ·Ongoing·Copan Italia·December 24, 2025

    PCRopsis BCSNano (1mL), REF 2276001; nucleic acid extraction from a variety of biological samples

    FDA Enforcement
    Class II ·Ongoing·Entopsis , Inc.·April 5, 2023

    Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: C-SECTION PREP, REF DYNJ32702B

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·July 30, 2025

    Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: LABOR TRIAGE KIT, REF DYKM1564

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·July 30, 2025

    Monoject(TM) 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, Model Number/Product Code: 1180100777

    FDA Enforcement
    Class II ·Ongoing·Cardinal Health 200, LLC·October 25, 2023

    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001973;

    FDA Enforcement
    Class II ·Ongoing·Beaver Visitec International, Inc.·September 4, 2024

    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001775;

    FDA Enforcement
    Class II ·Ongoing·Beaver Visitec International, Inc.·September 4, 2024

    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001200;

    FDA Enforcement
    Class II ·Ongoing·Beaver Visitec International, Inc.·September 4, 2024

    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000789;

    FDA Enforcement
    Class II ·Ongoing·Beaver Visitec International, Inc.·September 4, 2024