BEUDAMED
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    VENTANA ANTI-HELICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PRIMARY ANTIBODY

    FDA 510(k)
    FDA Class 1 ·Microbiology

    Preat

    FDA UDI
    Preat Corporation·00842092108116·Preci Ball Decrease Retention Tool

    Bur Cranial Straight 10mm St

    FDA UDI
    Bien-Air Surgery SA·17630055513844·

    Infiniti Plus™ Needle Guide

    FDA UDI
    CIVCO MEDICAL INSTRUMENTS CO., INC.·10841436102701·Sterile needle guide

    BIOCURVE SOFT (HIOXIFILCON B) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND BLUE VISIBILITY-HANDLING L

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    BIOINSULATED SILICONE PUNCTUM PLUG

    FDA 510(k)
    FDA Unclassified ·Unknown

    VASO VIEW HEMOPRO

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR LLC·Product code GEI·April 8, 2019

    VASOVIEW HEMOPRO 2

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR LLC·Product code GEI·April 13, 2019

    UNIFY ASSURA CRT-D

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·May 9, 2013

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 3, 2014

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 24, 2011

    HEMOPRO 2 ADAPTOR

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR LLC·Product code GEI·February 21, 2020

    CIVCO Infiniti Plus Needle Guide, Sterile Needle Guide, 12-18GA, Rx ONLY, STERILE EO. REFs 610-1215, 610-1234, 610-1235, 610-1236. Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.

    FDA Recall
    Terminated ·Civco Medical Instruments Co. Inc.·Product code ITX·October 21, 2015

    CIVCO Infiniti Plus Needle Guide, Sterile Needle Guide, 12-18GA, Rx ONLY, STERILE EO. REFs 610-1215, 610-1234, 610-1235, 610-1236. Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.

    FDA Enforcement
    Class II ·Terminated·Civco Medical Instruments Co. Inc.·November 25, 2015

    Dr. Wischmeier Pack, part numbers: AMS3509 and AMS3509(A Product packaged in a convenient manner for use in a general clinical procedure

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·April 19, 2017

    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

    Model Number L101, ESSENTIO DR SL Pacemaker

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

    Model Number L210 PROPONENT SR SL Pacemaker

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