BEUDAMED
    28 results · 20ms · Sources: EU EUDAMED, US FDA

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    ECG SINGLE PATIENT USE LEAD WIRE SET, MODELS 2048801-5 TO 2048801-8

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517287311·CoRoent® XLCT, 16x18x60mm

    Titanium Fishkind Eye Speculum

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896110885·Titanium Fishkind Eye Speculum Adjustable Mecha...

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·04546540134103·SIGM. NOTCH RETR., L., W/O F/O CABLE FIT

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587L101660120·10mm H x 16mm W x 60mm L XLIF Trial 12 degree L...

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523151264·Set Screw/Crosslink Caddy for 6.0mm Rod, PSS (MP)

    WECK CARDIAC PACING WIRES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MALLORY HEAD MODULAR CALCAR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GMK SPHERE TOTAL KNEE SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 3, 2025

    GALAXY G3 MINI 1MM X 4CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·June 19, 2020

    ANTI-A (MURINE MONOCLONAL) SERIES 1

    FDA Adverse Event
    Malfunction ·IMMUCOR, INC.·Product code KSZ·June 15, 2006

    9600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 1, 2013

    INTERSTIM

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·September 19, 2014

    8800

    FDA Adverse Event
    Malfunction ·GE MED SYSTEMS (INDIA) PRIVATE LTD·Product code JAA·May 11, 2011

    GALAXY G3 MINI 1MM X 4CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·October 1, 2022

    PriMatrix Ag; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm, 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, 8x8 cm.

    FDA Enforcement
    Class II ·Ongoing·TEI Biosciences, Inc.·July 12, 2023

    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

    Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Model Number L101, ESSENTIO DR SL 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