BEUDAMED
    28 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 ×

    SOLCART B

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Modular Handle - Charcoal

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215164973·

    TREATVISION

    FDA 510(k)
    FDA Class 2 ·Radiology

    BLOOD PRESSURE MONITOR (SPHYGMOMANOMETER), MODEL HT-110

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    2.4MM VA LOCKING SCREW STARDRIVE 22MM

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·June 25, 2013

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 30, 2025

    VA LOCKSCR Ø2.4 SELF-TAP L18 TAN

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HRS·July 15, 2013

    BAXANO IO-FLEX SYSTEM

    FDA Adverse Event
    Other ·BAXANO, INC.·Product code HAE·July 2, 2012

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·May 9, 2013

    2008K2 HEMODIALYSIS MACHINE

    FDA Adverse Event
    Malfunction ·FRESENIUS MEDICAL CARE NORTH AMERICA, CONCORD MANUFACTURING·Product code KDI·September 17, 2014

    STENOSCOP

    FDA Adverse Event
    Malfunction ·GE MEDICAL SYSTEMS (INDIA) PRIVATE, LTD. (GE PRIVATE)·Product code JAA·May 19, 2011

    BAXANO IO-FLEX SYSTEM

    FDA Adverse Event
    Other ·BAXANO, INC.·Product code HAE·July 2, 2012

    2.4MM TI LOCKING SCR SLF-TPN WITH STARDRIVE RECESS 18MM

    FDA Adverse Event
    Malfunction ·SYNTHES BETTLACH·Product code HWC·June 21, 2017

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code HWC·December 24, 2015

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code HWC·July 30, 2015

    2.4MM TI LOCKING SCR SLF-TPN WITH STARDRIVE RECESS 18MM

    FDA Adverse Event
    Malfunction ·SYNTHES BETTLACH·Product code HWC·June 21, 2017

    PLATE, FIXATION, BONE

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code HRS·October 24, 2015

    Ventlab Premium Small Adult Resuscitator, 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

    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