BEUDAMED
    10,000 results · 10ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Classification: Class Ii × Status: Ongoing × Clear all

    Syringes labeled as: a) SYR 10ML L/L CONTROL, Item Numbers: 1. DNSC91881, 2. DYNJSYRPPC10; b) SYRINGE 20ML BLUE L/L LOW PR, Item Number: DYNJSYRPP20B; c) SYRINGE 20ML RED L/L LOW PRESS, Item Number: DYNJSYRPP20R; d) SYRINGE 10ML RED L/L LOW PR, Item Number: DYNJSYRPP10R; e) SYRINGE 10ML GREEN L/L LOW PR, Item Number: DYNJSYRPP10G; f) SYRINGE 10ML WHITE L/L LOW PR, Item Number: DYNJSYRPP10W; g) SYRINGE CNTRL 10ML RED L/L LP, Item Number: DYNJSYCPP10R; h) SYRINGE 5ML YELLOW L/L LOW PR, Item Number: DYNJSYRPP5Y; i) SYRINGE CNTRL 10ML YEL L/L LP, Item Number: DYNJSYCPP10Y; j) SYRINGE 3ML YELLOW L/L LOW PR, Item Number: DYNJSYRPP3Y; k) SYRINGE 5ML WHITE L/L LOW PR, Item Number: DYNJSYRPP5W; l) SYRINGE,CONTROL,LL,FINGER GRIPS,10ML, Item Number: DYNJPOLYCON1

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·June 12, 2024

    Change Healthcare Cardiology Hemodynamics software

    FDA Enforcement
    Class II ·Ongoing·A L I Technologies Ltd·January 22, 2025

    Change Healthcare Cardiology Hemo software

    FDA Enforcement
    Class II ·Ongoing·A L I Technologies Ltd·January 22, 2025

    McKesson Cardiology Hemo software

    FDA Enforcement
    Class II ·Ongoing·A L I Technologies Ltd·January 22, 2025

    Icelock 125 Ratchet, REF: L-125000; Icelock 600XM Ratchet, REF: L-621200; Icelock 621 Ratchet, REF: L-621000; Icelock 621 Ratchet Adaption Kit, REF: L-621100; Ratchet Lock Body, REF: L-692020

    FDA Enforcement
    Class II ·Ongoing·Ossur H / F·June 21, 2023

    Various reprocessed products: PROVISION, Reprocessed Smith and Nephew Arthroscopic Shavers, STERILE EO; PROVISION Reprocessed Depy Mitek Ablation Electrodes, VAPR COOLPULSE 90 deg; PROVISION Reprocessed Smith and Nephew Trocars/ Cannulas (Class I); PROVISION Reprocessed Conmed/ Linvatec Suture Retrievers/ Passers C6387 See updated product list attached for details.

    FDA Enforcement
    Class II ·Ongoing·ReNovo, Inc.·March 10, 2021

    Medline Syringes: 1) SYRINGE 12ML CONTROL W/ROTATOR, Model Number: DYNJSYR12CWR; 2) SYRINGE 10ML CONTROL W/ROTATOR, Model Number: DYNJSYR10CWR; 3) SYR CONTROL PAD 12ML L/L, Model Number: DYNJSYR12CP; 4) TBG PRESS 72IN M/F ROT BRAID, Model Number: DYNJBRT72R; 5) SYRINGE 10ML CONTROL MLL, Model Number: DYNJSYR10C; 6) SYRINGE 8ML CONTROL MLL, Model Number: DYNJSYR8C; 7) SYRINGE 12ML CONTROL MLL, Model Number: DYNJSYR12C; 8) SYR CONTROL PAD 10ML L/L ROT, Model Number: DYNJSYR10CRP; 9) SYR CONTROL PAD 12ML L/L ROT, Model Number: DYNJSYR12CRP; 10) CTRL SYRINGE 6ML RING ROT L/L, Model Number: DYNJSYRC6CWR

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·April 29, 2026

    SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L Prepared with Dipotassium EDTA Purple, Model: 07 6011; SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L Prepared with Dipotassium EDTA Self-sealing Cap, Purple, Model: 07 6013; SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L Prepared with Dipotassium EDTA Purple, Model: 07 7051; SAFE-T-FILL Micro Capillary Blood Collection, 150 ¿L Prepared with Dipotassium EDTA Purple, Model: 07 7052; SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L Prepared with Dipotassium EDTA Purple, Model: 07 7053; SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L Prepared with Dipotassium EDTA Purple, Model: 07 7056; SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L Prepared with Dipotassium EDTA Flat Bottom Microtube, Purple, Model: 07 7058 SAFE-T-FILL¿ End-to-End Capillary Tubes, 30 ¿L; Plastic, Prepared with EDTA Dipotassium Model: 06 0910

    FDA Enforcement
    Class II ·Ongoing·ASP Global, LLC. dba Anatomy Supply Partners, LLC.·November 5, 2025

    CareEvent Event Management System, Model Numbers 866435 and 866436 (CareEvent Upgrade), Software Version Number C.03.X

    FDA Enforcement
    Class II ·Ongoing·Philips North America·April 3, 2024

    GORE ACUSEAL Vascular Graft, REF: ECH050020J, ECH050020W, ECH050050J, ECH050050W, ECH060010A, ECH060020A, ECH060020J, ECH060020W, ECH060040, ECH060040A, ECH060040W, ECH060050A, ECH060050J, ECH460045A, ECH460045J, ECH470045, ECH470045A; used with Instructions for Use.

    FDA Enforcement
    Class II ·Ongoing·W L Gore & Associates, Inc.·October 8, 2025

    GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System

    FDA Enforcement
    Class II ·Ongoing·W L Gore & Associates, Inc.·November 4, 2020

    GORE TAG CONFORMABLE Thoracic Stent Graft with ACTIVE CONTROL System

    FDA Enforcement
    Class II ·Ongoing·W L Gore & Associates, Inc.·November 4, 2020

    REF/Catalogue Number GSXE0030B, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132620128 *Not distributed within the US

    FDA Enforcement
    Class II ·Ongoing·W L Gore & Associates, Inc.·November 3, 2021

    REF/Catalogue Number GSXE0030, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132617661 *Not distributed within the US

    FDA Enforcement
    Class II ·Ongoing·W L Gore & Associates, Inc.·November 3, 2021

    REF/Catalogue Number GSX0025A, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132631025 *Not distributed within the US

    FDA Enforcement
    Class II ·Ongoing·W L Gore & Associates, Inc.·November 3, 2021

    GORE CARDIOFORM Septal Occluder, REF: GSX0030A

    FDA Enforcement
    Class II ·Ongoing·W L Gore & Associates, Inc.·February 8, 2023

    Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 6 mm, Length 15 cm, Rx Only, Sterile EO, for the following Reference numbers: HPT060015 UDI: (01)00733132606368 HPT060015A UDI: (01)00733132606375

    FDA Enforcement
    Class II ·Ongoing·W L Gore & Associates, Inc.·August 25, 2021

    Gore Molding & Occlusion Balloon Catheter, REF Catalogue Number MOB37, SN XXXXXXXX, 10 mm - 37 m 10 Fr, Guidewire Compatibility 0.035", STERILE EO, CE2797, UDI: (00)733132639489

    FDA Enforcement
    Class II ·Ongoing·W. L. Gore & Associates Inc.·September 1, 2021

    REF/Catalogue Number GSXE0025, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132617647 *Not distributed within the US

    FDA Enforcement
    Class II ·Ongoing·W L Gore & Associates, Inc.·November 3, 2021

    REF/Catalogue Number GSX0020A, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132631018

    FDA Enforcement
    Class II ·Ongoing·W L Gore & Associates, Inc.·November 3, 2021