BEUDAMED
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    MODIFICATION TO:EXPEDIUM SPINE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Mesh|Ex

    FDA UDI
    EXSURCO MEDICAL, INC.·00810006780215·ASM, Exsurco Mesher Base

    Oticon

    FDA UDI
    Oticon A/S·05707131158260·VGC, BTE DBL VIGO CONNECT

    Tasso+ Convenience Kit

    FDA UDI
    Tasso Inc.·00850038691035·

    WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/COBAS BIO

    FDA 510(k)
    FDA Class 2 ·Immunology

    GLYCOSAL II HBA 1C TEST

    FDA 510(k)
    FDA Class 2 ·Hematology

    SEALING UNIT FROM 5MM TROCARS

    FDA Adverse Event
    Malfunction ·AESCULAP AG & CO KG·Product code GCJ·June 17, 2015

    REDUCING CONVERTER 10/12MM TO 5MM

    FDA Adverse Event
    Malfunction ·AESCULAP AG & CO KG·Product code GCJ·June 17, 2015

    E SERIES DEFIBRILLATOR

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

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·September 19, 2014

    OLYMPUS EVIS EXERA II XENON LIGHT SOURCE

    FDA Adverse Event
    Malfunction ·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code GCT·May 17, 2011

    ATTUNE RP TIB BASE SZ 6 CEM

    FDA Adverse Event
    Malfunction ·DEPUY IRELAND - 9616671·Product code NJL·July 15, 2021

    CONQUEST PRO 12 ST

    FDA Adverse Event
    Injury ·ASAHI INTECC CO., LTD.·Product code DQX·July 16, 2025

    ASTATO XS 9-12

    FDA Adverse Event
    Malfunction ·ASAHI INTECC CO., LTD.·Product code DQX·June 24, 2025

    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

    Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·November 6, 2024

    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

    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