BEUDAMED
    1,320 results · 16ms · 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 Status: Open, Classified ×

    GE HealthCare CRITIKON ONE-CUF blood pressure cuffs, Model numbers: 1. ONE-A1-1B, ONE-CUF, SMALL ADULT, 1 TB BAYONET, 17 - 25 CM, 20/BOX; 2. ONE-A1-2A, ONE-CUF, SMALL ADULT, DINACLICK 80369-5, 17 - 25 CM, 20/BOX; 3. ONE-A2-1B, ONE-CUF, ADULT, 1 TB BAYONET, 23 - 33 CM, 20/BOX; 4. ONE-A1-1B-L, ONE-CUF, ADULT LONG, 1 TB BAYONET, 23 - 33 CM, 20/BOX; 5. ONEA2-2A, ONE-CUF, ADULT, DINACLICK 80369-5, 23 - 33 CM, 20/BOX; 6. ONE-A2-2A-L, ONE-CUF, ADULT LONG, DINACLICK 80369-5, 23 - 33 CM, 20/BOX; 7. ONE-A3-1B, ONE-CUF, LARGE ADULT, 1 TB BAYONET, 31 - 40 CM, 20/BOX; 8. ONE-A3-2A, ONE-CUF, LARGE ADULT, DINACLICK 80369-5, 31 - 40 CM, 20/BOX; 9. ONE-P1-1B, ONE-CUF, INFANT, 1 TB BAYONET, 08 - 13 CM, 20/BOX; 10. ONE-P1-2A, ONE-CUF, INFANT, DINACLICK 80369-5, 08 - 13 CM, , 20/BOX; 11. ONE-P2-1B, ONE-CUF, CHILD, 1 TB BAYONET, 12 - 19 CM, 20/BOX; and 12. ONE-P2-2A, ONE-CUF, CHILD, DINACLICK 80369-5, 12 - 19 CM, 20/BOX.

    FDA Recall
    Open, Classified ·GE Medical Systems Information Technologies Inc·Product code DXQ·April 9, 2024

    Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App Model/Catalog Number: SW14244 Software Version: versions 1.4.0 and earlier Product Description: Dexcom ONE+ iOS CGM App Component: Dexcom ONE+ Continuous Glucose Monitoring System

    FDA Recall
    Open, Classified ·Dexcom, Inc.·Product code QBJ·July 24, 2025

    Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App Model/Catalog Number: SW14244 Software Version: versions 1.5.0 and 1.6.0 Product Description: Dexcom ONE+ iOS CGM App Component: Dexcom ONE+ Continuous Glucose Monitoring System

    FDA Recall
    Open, Classified ·Dexcom, Inc.·Product code QBJ·April 14, 2026

    Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ Android CGM App Model/Catalog Number: SW14245 Software Version: versions 1.4.0 and earlier Product Description: Dexcom ONE+ Androind CGM App Component: Dexcom ONE+ Continuous Glucose Monitoring System

    FDA Recall
    Open, Classified ·Dexcom, Inc.·Product code QBJ·July 24, 2025

    InSure ONE Fecal Immunochemical Test. Labeled as follows: 1. Insure ONE POL Patient Kit - 10 pack. Model Number: 90010. 2. Insure ONE POL Patient Kit - 25 Pack. Model Number: 90025. 3. InSure ONE POL Combo Pack. Model Number: 90030. InSure ONE is a fecal immunochemical test (FIT) that qualitatively detects human hemoglobin from blood in fecal samples.

    FDA Recall
    Open, Classified ·Enterix, Inc.·Product code KHE·September 17, 2025

    Box as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quantity 1 Box of 3 Systems. Kit as labeled: Regard, Carter-Thomason CloseSure System, REF 733776, Contents: One (1) Carter-Thomason Suture Passer, One (1) 5 mm Pilot Guide, One (1) 10/12 mm Pilot Guide.

    FDA Recall
    Open, Classified ·CooperSurgical, Inc.·Product code GCJ·August 29, 2023

    VACUETTE TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridged

    FDA Recall
    Open, Classified ·Greiner Bio-One North America, Inc.·Product code JKA·May 14, 2024

    Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Model/Catalog Number: 455071P Product Description: Greiner VACUETTE Blood Collection Tube with Clot Activator and Gel Separator and Standard Stopper (16 x 100 mm, 8ml)

    FDA Recall
    Open, Classified ·Greiner Bio-One North America, Inc.·Product code JKA·August 19, 2025

    Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322

    FDA Recall
    Open, Classified ·Greiner Bio-One North America, Inc.·Product code GIM·August 8, 2025

    VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate, Item #454297, 13x75 grey cap-black ring, non-ridged.

    FDA Recall
    Open, Classified ·Greiner Bio-One North America, Inc.·Product code JKA·December 12, 2023

    Medtronic Arterial Cannulae packaged as: a) DLP Curved Metal Tip Arterial Cannula 20 Fr., Model Number 80020; b) DLP Curved Metal Tip Arterial Cannula 20 Fr., Model Number 80220; c) DLP Curved Metal Tip Arterial Cannula 20 Fr., Model Number 82020; d) DLP Curved Metal Tip Arterial Cannula 20 Fr., Model Number 87120; e) DLP Curved Metal Tip Arterial Cannula 22 Fr. , Model Number 80222; f) DLP Curved Metal Tip Arterial Cannula 22 Fr. , Model Number 87122; g) DLP Curved Tip Arterial Cannula 20 Fr., Model Number 87220; h) DLP Curved Tip Arterial Cannula 22 Fr., Model Number 87222; i) DLP" One-Piece Arterial Cannulae, Pediatric 6 Fr, Model Number 77006; j) DLP" One-Piece Pediatric Arterial Cannula 6 Fr, Model Number 77206; k) DLP" One-Piece Pediatric Arterial Cannula 8 Fr, Model Number 77008; l) DLP" One-Piece Pediatric Arterial Cannula 10 Fr, Model Number 77010; m) DLP" One-Piece Pediatric Arterial Cannula 10 Fr, Model Number 77110; n) DLP" One-Piece Pediatric Arterial Cannula 12 Fr, Model Number 77112; o) EOPA" Elongated One Piece Arterial Cannula 20 Fr., Model Number 77420; p) EOPA" Elongated One Piece Arterial Cannula 22 Fr., Model Number 77422; q) EOPA" Elongated One Piece Arterial Cannula 22 Fr., Model Number 77522; r) EOPA" Elongated One Piece Arterial Cannula 22 Fr., Model Number 77622; s) EOPA" Elongated One Piece Arterial Cannula 24 Fr., Model Number 77524; t) Select Series" Angled Tip Arterial Cannula 24Fr., Model Number 72424; u) Select Series" Straight Tip Arterial Cannula 20 Fr., Model Number 72120; v) Select Series" Straight Tip Arterial Cannula 24 Fr., Model Number 72224

    FDA Recall
    Open, Classified ·Medtronic Perfusion Systems·Product code DWF·March 19, 2024

    CARESCAPE ONE, Model no. 2087075-300 - shipped with potentially affected batteries or affected batteries installed as a spare part Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms Updated 3/19 to add CARESCAPE ONE MBZ101 2087075-001

    FDA Recall
    Open, Classified ·GE Healthcare Finland Oy Kuortaneenkatu 2 Helsinki Finland·Product code MHX·September 26, 2025

    Canon Aquilion One, Model TSX-301A

    FDA Recall
    Open, Classified ·Canon Medical System, USA, INC.·Product code JAK·March 25, 2019

    DENTEMP ONE STEP .077OZ, SKU 902139

    FDA Recall
    Open, Classified ·Family Dollar Stores, Llc.·Product code EMA·October 4, 2023

    DENTEMP ONE STEP .077OZ, SKU 902139

    FDA Recall
    Open, Classified ·Family Dollar Stores, Llc.·Product code EMA·June 23, 2022

    ARTIS One Angiographic X-Ray System

    FDA Recall
    Open, Classified ·SIEMENS MEDICAL SOLUTIONS USA, INC·Product code OWB·January 2, 2025

    BIOGRAPH One (DE). Model Number: 11689172.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    VACUETTE SAFELINK, REF: 450210

    FDA Recall
    Open, Classified ·Greiner Bio-One GmbH Bad Haller Strase·Product code FMI·November 19, 2024

    One Step Ovulation Test REF 200-01

    FDA Recall
    Open, Classified ·Universal Meditech Inc.·Product code NGE·May 22, 2023

    Alcon PRECISION1 One-Day Contact Lenses, -2.25D.

    FDA Recall
    Open, Classified ·Alcon Research LLC·Product code LPL·September 30, 2025