BEUDAMED
    1,856 results · 13ms · 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 ×

    Alcohol (ALC) Test Saliva

    FDA Recall
    Open, Classified ·GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden·Product code DIC·November 3, 2025

    iLED 7 surgical lights, Model Numbers: a) 4068110 (Ceiling Single Surgical Light); b) 4068120 (Mobile Surgical Light); c) 4068140 (Pendant Surgical Light); d) 4068210 (Ceiling Duo Surgical Lights); e) 4068310 (Ceiling Trio Surgical Lights); f) 4068410 (Ceiling Quad Surgical Lights)

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code FTD·June 4, 2024

    VidiaPort carrying arm, mount for auxiliary products, model numbers: a) 4028110 (Ceiling Single Surgical Light); b) 4028210 (Ceiling Duo Surgical Lights); c) 4028310 (Ceiling Trio Surgical Lights)

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code KQM·June 4, 2024

    Trulight 5000/3000 Surgical Light, model numbers: a) 4038210 (Duo Surgical Lights}; b) 4038310 (Trio/Quad Surgical Lights)

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code FTD·June 4, 2024

    Illuminated Stepped Laser Probe Curved-for use in combination with 23G vitrectomy system Product Code: 7510.ALC

    FDA Recall
    Open, Classified ·Dutch Ophthalmic USA, Inc.·Product code HQF·April 14, 2021

    Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE

    FDA Recall
    Open, Classified ·Electro Medical Systems SA Chemin De La Vuarpilliere·Product code ELC·March 13, 2024

    Titan Scaler Tip - Perio Model/Catalog Number: 261669 The scaler tip is used with an air drive scaler for subgingival scaling and fine access. The Perio tip is used for lingual supragingival scaling of mandibular incisors and deep local pockets.

    FDA Recall
    Open, Classified ·Dental EZ Group Star Dental Division·Product code ELC·May 30, 2024

    Brand Name: PIEZON Bottle Product Name: PIEZON Bottle Model/Catalog Number: EG-111 Software Version: N/A Product Description: These bottles are sold empty and are filled by the user with water - in some cases small quantities of disinfectant solutions - for dental treatments. The bottle is pressurized on the device during use. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE

    FDA Recall
    Open, Classified ·Electro Medical Systems SA Chemin De La Vuarpilliere·Product code ELC·March 13, 2024

    GentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02

    FDA Recall
    Open, Classified ·Sonendo Inc·Product code ELC·October 14, 2022

    7.5 cm Large Rotating Craniotome Attachment. Use with XMax, microMax, and eMax Systems Ref: CRANI-L-R Intended for cutting and shaping bone including the spine and cranium

    FDA Recall
    Open, Classified ·The Anspach Effort, Inc.·Product code HBC·December 7, 2022

    Brand Name: WATER BOTTLE Product Name: WATER BOTTLE Model/Catalog Number: EG-121 Software Version: N/A Product Description: These bottles are sold empty and are filled by the user with water fort dental treatments. The bottle is pressurized on the device during use. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE

    FDA Recall
    Open, Classified ·Electro Medical Systems SA Chemin De La Vuarpilliere·Product code ELC·March 13, 2024

    6.5 cm Adult Craniotome, Thin Foot Plate Attachment. Use with XMax, microMax, and eMax Systems Ref: CRANI-A-01 intended for cutting and shaping bone including the spine and cranium by trained medical/surgical personnel

    FDA Recall
    Open, Classified ·The Anspach Effort, Inc.·Product code HBC·December 7, 2022

    6.5 cm Adult Rotating Craniotome Attachment. Use with XMax, microMax, and eMax Systems Ref: CRANI-A-R intended for cutting and shaping bone including the spine and cranium

    FDA Recall
    Open, Classified ·The Anspach Effort, Inc.·Product code HBC·December 7, 2022

    Adult Craniotome Ref: CRANI-A-G1 Intended for cutting and shaping bone including the spine and cranium

    FDA Recall
    Open, Classified ·The Anspach Effort, Inc.·Product code HBC·December 7, 2022

    GentleWave System Posterior CleanFlow Procedure Instrument with Matrices (Single) REF GW-PST-PI01

    FDA Recall
    Open, Classified ·Sonendo Inc·Product code ELC·October 14, 2022

    6.5 cm Adult Rotating Craniotome Attachment. Use with XMax, microMax, and eMax Systems. Ref: CRANI-A Intended for cutting and shaping bone including the spine and cranium

    FDA Recall
    Open, Classified ·The Anspach Effort, Inc.·Product code HBC·December 7, 2022

    Pediatric Craniotome Ref:CRANI-P-G1

    FDA Recall
    Open, Classified ·The Anspach Effort, Inc.·Product code HBC·December 7, 2022

    Titan Blis-Sonic Scaler packaged with the Titan Scaler Tip - Perio (part number 261669) (1) P/N 264563 (2) P/N 264565 The scaler tip is used with an air drive scaler for subgingival scaling and fine access. The Perio tip is used for lingual supragingival scaling of mandibular incisors and deep local pockets.

    FDA Recall
    Open, Classified ·Dental EZ Group Star Dental Division·Product code ELC·May 30, 2024

    The "Pacifier Activated Lullaby" (PAL) System composed of three major components: 1) the PAL Player Module (aka Player Unit), 2) the PAL Pacifier Sensor, and 3) power supply. The system is designed to encourage and reinforce effective non-nutritive sucking of premature infants.

    FDA Recall
    Open, Classified ·Powers Medical Devices, LLC·Product code HCC·October 1, 2015

    7.5 cm Large Craniotome Attachment Use with XMax, microMax, and eMax Systems. Ref: CRANI-L Intended for cutting and shaping bone including the spine and cranium

    FDA Recall
    Open, Classified ·The Anspach Effort, Inc.·Product code HBC·December 7, 2022