BEUDAMED
    20 results · 19ms · Sources: EU EUDAMED, US FDA

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    EMBRACE

    FDA 510(k)
    FDA Class 2 ·Radiology

    Preat

    FDA UDI
    Preat Corporation·00842092108888·Preci-Sagix 2.2 Threaded Male

    Bur PM2-70 80K FC Ø2.5 St

    FDA UDI
    Bien-Air Surgery SA·17630055519488·

    INSTRUMENT DAMPING PORT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LIQUICHEK IMMUNOASSAY PLUS CONTROL, MODEL 360, 361, 362, 363

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    MODULAR LATERALIZED TAPERLOC FEMORAL POROUS COATED 12.5 X 145 MM STEM TYPE I TAP

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code LPH·November 15, 2012

    MINICAP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SWINFORD·Product code KDI·September 24, 2015

    1.1MM THREADED GUIDE WIRE 150MM

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code FZX·May 9, 2013

    FLOGARD

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 19, 2014

    M2A MAGNUM MODULAR HEAD 54MM HEAD DIAMETER

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·August 21, 2012

    4.5 BROAD SCP PLT 26-H STER

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·June 21, 2017

    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

    INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273

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

    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

    Spacelabs Healthcare XPREZZON Bedside Monitor, Model 91393. The Spacelabs Healthcare XPREZZON Bedside Monitor passively displays data generated by Spacelabs parameter modules, Flexport interfaces, and other Spacelabs SDLG based products as waveform and numeric displays, trends and alarms. Key monitored parameters available on the model 91393, when employing the Spacelabs Command Module consist of EGG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·March 4, 2015

    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

    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

    INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f) W173

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

    ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)

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

    BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators are anesthesia gas machine. In most cases, the customer ordered both a BleaseFocus anesthesia workstation and a 700/900 ventilator. In some cases, the customer may order a 700/900 stand-alone ventilator would could be used with a BleaseFocus anesthesia workstation at a later date.

    FDA Enforcement
    Class II ·Terminated·Del Mar Reynolds Medical, Ltd.·December 26, 2012