BEUDAMED
    18 results · 24ms · 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 Regulation: Us FDA ×

    Blade Scalpel

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113455·SUPER SHARPS 15 DEG 5MM (BX/5)

    Carewear Firefly Wrinkle Reduction

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    16PW - Washington Gas - Poly White

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588014425·16PW - Washington Gas - Poly White

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113424·CRESCENT KNIFE BEVEL UP (BX/5)

    POWDER FREE GREEN LATEX SURGICAL GLOVES, STERILE WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM LESS)

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    E.S.O. (ELECTRO SENSOR OXI)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HUGO? RAS

    FDA Adverse Event
    Injury ·SURGICAL·Product code SCV·February 16, 2026

    HUGO? RAS

    FDA Adverse Event
    Injury ·SURGICAL·Product code SCV·February 16, 2026

    PICC SET: 3-LUMEN 6 FR X 50 CM

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC.·Product code LJS·September 18, 2014

    UNKNOWN STRYKER HIP

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS MAHWAH·Product code JDI·August 5, 2011

    GOBED II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·July 2, 2013

    ACCUPORT

    FDA Adverse Event
    Injury ·ZIMMER KNEE CREATIONS, INC.·Product code FGY·December 20, 2016

    UNKNOWN VLOC PRODUCT

    FDA Adverse Event
    Injury ·COVIDIEN LP LLC NORTH HAVEN·Product code GAM·September 25, 2024

    SENSOR UROLOGICAL GUIDEWIRE

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code EZB·June 18, 2025

    EXCOR®

    FDA Adverse Event
    Malfunction ·BERLIN HEART GMBH·Product code DSQ·December 27, 2024

    Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. Azurion 3 M12, Model Number 722063. 2. Azurion 3 M15, Model Number 722064. 3. Azurion 7 B12, Model Number 722067. 4. Azurion 7 B20, Model Number 722068. 5. Azurion 7 M12, Model Number 722078. 6. Azurion 7 M20, Model Number 722079. 7. Azurion 3 M12, Model Number 722221. 8. Azurion 3 M15, Model Number 722222. 9. Azurion 7 M12, Model Number 722223. 10. Azurion 7 M20, Model Number 722224. 11. Azurion 7 B12, Model Number 722225. 12. Azurion 7 B20, Model Number 722226. 13. Azurion 5 M12, Model Number 722227. 14. Azurion 5 M20, Model Number 722228. 15. Azurion 7 M20, Model Number 722282.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·September 10, 2025

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021