BEUDAMED
    24 results · 27ms · 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.

    WERNLI AG

    FDA registration
    WERNLI AG·3 products·🇨🇭 Switzerland

    HAMILTON-C6

    FDA Adverse Event
    Malfunction ·HAMILTON MEDICAL AG·Product code CBK·December 18, 2025

    Artegraft Collagen Vascular Grafts Model Numbers: (1) AG 616, (2) AG 630, (3) AG 636, (4) AG 640, (5) AG 645, (6) AG 715, (7) AG 730, (8) AG 735, (9) AG 740, (10) AG 745, (11) AG 750, (12) AG 830, (13) AG 840, (14) AG 1015, (15) AG 1030;

    FDA Enforcement
    Class II ·Ongoing·LeMaitre Vascular, Inc.·October 8, 2025

    Laserworld RGB & Piko Nano RGB Models All models are laser light show projectors, and will be used as such.

    FDA Enforcement
    Class II ·Terminated·Laserworld Usa Inc·September 25, 2013

    ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code GBO·January 16, 2023

    UNKNOWN HIP ACETABULAR CUP

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·August 15, 2019

    UNKNOWN HIP FEMORAL STEM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWY·August 15, 2019

    LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit Catalog #: L016080109002 (EUA) The LumiraDx SARS-CoV-2 Quality Controls are intended for liquid quality control testing performed on the LumiraDx Instrument when used with the LumiraDx SARS-CoV-2 Ag Test Strip. The Quality Controls provide users with assurance that the device is performing within specification

    FDA Enforcement
    Class III ·Terminated·LumiraDx·November 2, 2022

    Laserworld RGB & Piko Nano RGB Models All models are laser light show projectors, and will be used as such.

    FDA Recall
    Terminated ·Laserworld Usa Inc·Product code REA·July 19, 2012

    Celltrion DiaTrust COVID-19 Ag Rapid Test, REF CT-P60 D-2 01. Contains 25 disposable test tubes with extraction buffer, 25 filter caps, 25 sterilized swabs per box.

    FDA Recall
    Terminated ·CELLTRION USA INC·Product code QKP·December 1, 2021

    Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02

    FDA Enforcement
    Class II ·Ongoing·CELLTRION USA INC·March 16, 2022

    Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02

    FDA Enforcement
    Class I ·Terminated·CELLTRION USA INC·March 9, 2022

    Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02

    FDA Enforcement
    Class I ·Terminated·CELLTRION USA INC·March 9, 2022

    Roscoe Mini Neb Compressor User Manual for the NEB-ROS Product Usage: Inhaler therapy that converts liquid medicine into a fine mist that is easily inhaled.

    FDA Enforcement
    Class II ·Terminated·Compass Health Brands·June 17, 2015

    Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02

    FDA Enforcement
    Class I ·Terminated·CELLTRION USA INC·May 4, 2022

    PrepIT Q2A Kit, Model PT-Q2A-96 containing component reagent AG (PT-QAG-96) 1.4mL and ST (PT-QST-96) 2.9mL - Product Usage: used for the removal of SDS and other inhibitors from samples collected using DNA Genotek oral sample collection kits.

    FDA Enforcement
    Class III ·Terminated·DNA Genotek Inc.·September 30, 2020

    ddRCombi Plus FP, Model Number 8.2000.0070.0 (US Version), 8.2000.0060.0 (Europe Version) The ddRCombi Plus FP is a fully digital, multifunctional X-ray system that allows the direct digitization of X-ray information without use of cassettes or other media. It can perform all applications in orthopedics and trauma as well as pulmonary imaging.

    FDA Recall
    Terminated ·Swissray Medical AG Turbistrasse 25-27 Hochdorf Switzerland·Product code MQB·November 14, 2018

    HAMILTON-C2 Ventilator: Manufactured by Hamilton Medical AG CH-7402 Bonaduz, Switzerland; Imported and distributed by Hamilton Medical, Inc. Reno, NV 89502 The HAMILTON C2 ventilator is intended to provide positive pressure ventilatory support to adults, pediatrics, infants and neonates depending on its configuration. Intended areas of use: In the intensive care ward or in the recovery room; During transfer of ventilated patients within the hospital.

    FDA Enforcement
    Class II ·Terminated·Hamilton Medical, Inc.·November 13, 2013

    Brand: The ForeCYTE Breast Health Test, Mammary Aspiration Specimen Cytology Test (MASCT), MASCT System Kits, Clarity System Kits, MASCT Patient Sample Kits & Clarity Patient Sample Kits Instrument, Biopsy. The MASCT System Kit, Patient Sample Kits, or the Nipple Aspirate Fluid Laboratory Kit has the following codes: PRODUCT CODE: AG-MASCT; AG-FC5; DTG-MASCT, DTG-FC5, and NRLBH-5. PART NUMBER: 9002513; 9002513MD; 9002528; 9002528MD; 9002587; 9002614; and 9002717MD. THE MASCT SYSTEM KIT CONSISTS OF: 1. MASCT Breast Pump; 2. Instructions for Use (IFU); 3. Heating Pad; 4. Timer; 5. Saccomono's Fixative; 6. Nu Prep Gel; 7. Welcome and Training Materials Coversheet; 8. MASCT System Order Form; 9. ForeCYTE Training Video DVD; 10. MASCT System Instructions with pictures - pink; THE PATIENT SAMPLE KIT CONSISTS OF: 1. Two (2) flower assemblies (e.g., filter, filter retainer, and filter holder); 2. Instructions for Use (IFU); 3. Two (2) specimen collection devices; 4. Two (2) breast bags for transporting the specimen collection container; 5. Barcode labels; 6. Saccomono's Fixative; 7. Nu Prep Gel; 8. MASCT System package insert; 9. ForeCYTE Test Requisition Form; 10. Patient Information Sheet; 11. Atossa Patient Information; 12. FED EX Clinical PAK; 13. MASCT System Order Form; 14. FED EX Pouch; 15. FED EX Airbill; Product Usage: The MASCT Device is intended for use in the collection of nipple aspirate fluid for cytological testing. The collected fluid can be used in the determination and/or differentiation of normal versus premalignant versus malignant cells.

    FDA Enforcement
    Class I ·Terminated·Atossa Genetics, Inc.·November 6, 2013

    SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: COHERENCE AG TH, Part No. 5863506, Current R630; Product Usage: The intended use of the SIEMENS branded ONCOR and PRIMUS family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·April 10, 2013