BEUDAMED
    25 results · 23ms · Sources: EU EUDAMED, US FDA

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    VENTRALEX ST HERNIA PATCH

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

    Chroma2 7 Lead Patient Cable

    FDA UDI
    SCOTTCARE CORPORATION, THE·00856298006107·5 lead ECG patient cable to be used with the Ch...

    ZIMMER AIR DERMATOME

    FDA Adverse Event
    Injury ·ZIMMER SURGICAL, INC.·Product code GFD·March 29, 2017

    HYDROTOWER ARTHROSCOPIC ADMINISTRATION TUBING SET, MODEL 7-460-05

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SIGMA

    FDA 510(k)
    FDA Class 2 ·Dental

    GYNECARE GYNEMESH PS

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code FTL·August 24, 2005

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code LWR·August 3, 2017

    AED PLUS

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·April 19, 2013

    SEE H-10

    FDA Adverse Event
    Injury ·STAAR SURGICAL COMPANY·Product code MJP·September 19, 2014

    MICRO SAGITTAL SAW

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code ERL·May 18, 2011

    GALAXY G3 MINI 2MM X 4CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·June 16, 2021

    GALAXY G3 5MM X 15CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·June 16, 2021

    GALAXY G3 MINI 3MM X 8CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·June 16, 2021

    GALAXY G3 MINI 2MM X 3CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·June 16, 2021

    AirFlow, Small Adult Resuscitator, AF5000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028 The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.

    FDA Enforcement
    Class I ·Terminated·Ventlab Corporation·November 7, 2012

    Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410 Surgical Energy Platform (SEP). Model Number: WA91327U. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments during open surgery, laparoscopic surgery, including single-site surgery, and endoscopic surgery.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·August 27, 2025

    Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 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

    Model Number L231, PROPONENT DR EL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·July 14, 2021