BEUDAMED
    21 results · 28ms · Sources: EU EUDAMED, US FDA

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    WUNDER TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    JOBST Bella Strong

    FDA UDI
    BSN MEDICAL, INC.·00035664010744·BELLA STRONG 30-40 MM HG ARMSLEEVE KNIT WELT SI...

    GUTTA PERCHA POINTS

    FDA UDI
    DiaDent Group International·08806383502368·Gutta Percha Points is used to root canal filin...

    MODIFICATION TO: LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    MASIMO RAINBOW SET RADICAL 7R PULSE CO-OXIMETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ARSTASIS ACCESS SYSTEM

    FDA Adverse Event
    Other ·ARSTASIS INC.·Product code DYB·November 15, 2010

    ARSTASIS ACCESS SYSTEM

    FDA Adverse Event
    Malfunction ·ARSTASIS, INC.·Product code DYB·November 19, 2010

    ARSTASIS ACCESS SYSTEM

    FDA Adverse Event
    Other ·ARSTASIS, INC.·Product code DYB·November 22, 2010

    ARSTASIS ACCESS SYSTEM

    FDA Adverse Event
    Injury ·ARSTASIS, INC.·Product code DYB·November 1, 2010

    OUTLOOK ES

    FDA Adverse Event
    Malfunction ·B. BRAUN MEDICAL, INC.·Product code FRN·April 30, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE REHABILITATION EQUIP·Product code CAW·September 19, 2014

    DEXTRUS 4136

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code NVZ·May 19, 2011

    ESG-410 Electrosurgical Generator- In conjunction with electrosurgical accessories intended for cutting and coagulation of tissue in open, laparoscopic , and endoscopic surgeries Model/Catalog Number: WA91307C

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·July 31, 2024

    Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410. Model Number: WA91307C. 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

    EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

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

    Model Number L211 PROPONENT DR SL MRI Pacemaker

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

    VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Model Number L131, ESSENTIO DR EL MRI Pacemaker

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