BEUDAMED
    17 results · 18ms · Sources: EU EUDAMED, US FDA

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    LUMISCOPE ALTERNATING PRESSURE PAD & PUMP

    FDA 510(k)
    FDA Class 2 ·General Hospital

    GRADIA®

    FDA UDI
    Gc America Inc.·D0479010961·GRADIA PLUS Paste LB-Base ODW, 2ml 1pc

    Welch Allyn, Inc.

    FDA UDI
    WELCH ALLYN, INC.·00732094211078·ProBP 2400 Digital Blood Pressure Device (Inclu...

    Stern IC/AC RN 2mm Healing Cap .048 Hex

    FDA UDI
    STERNGOLD DENTAL LLC·00841549107030·Healing Caps are intended for placement onto th...

    ERGONOMIC HIGHLY RIGID PLASTIC RING HANDLE

    FDA UDI
    SONTEC INSTRUMENTS, INC.·B09929010960·ERGONOMIC HIGHLY RIGID PLASTIC RING HANDLE WITH...

    ERGONOMIC HIGHLY RIGID PLASTIC RING HANDLE

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896007383·ERGONOMIC HIGHLY RIGID PLASTIC RING HANDLE WITH...

    NATURAZ SERIES, MODEL B16,B20, B42, B60, B98, B100

    FDA 510(k)
    FDA Class 2 ·Dental

    BURR HOLE COVER, MODEL XX

    FDA 510(k)
    FDA Class 2 ·Neurology

    EVOLUTION SQUID TOOL FOR ASSEMBLY AND DISASSEMBLY

    FDA Adverse Event
    Malfunction ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code LXH·December 13, 2018

    QUADRA ASSURA DR CRT-D

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·June 30, 2014

    POSEY WIRELESS IR ALARM

    FDA Adverse Event
    Malfunction ·J. T. POSEY CO.·Product code KMI·November 10, 2010

    URETEX SUPPORT PP KIT X1

    FDA Adverse Event
    Injury ·SOFRADIM PRODUCTION·Product code FTL·November 7, 2012

    Welch Allyn ProBP 2400 Digital Blood Pressure Device #2400, REF 901096, Rx ONLY, Made in China --- Distributed by Welch Allyn Inc., 4341 State Street Road, Skaneateles Falls, NY 13153 --- Microlife Corporation 9F, 431, RuiGuang Road, NeiHu, Taipei, 11492, Taiwan, R.O.C. --- Microlife AG Espenstrasse 139 9443 Widnau, Switzerland

    FDA Enforcement
    Class II ·Terminated·Welch Allyn Inc·April 19, 2017

    Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.

    FDA Enforcement
    Class I ·Ongoing·Zyno Medical LLC·June 18, 2025

    Welch Allyn ProBP 2400 Digital Blood Pressure Device #2400, REF 901096, Rx ONLY, Made in China --- Distributed by Welch Allyn Inc., 4341 State Street Road, Skaneateles Falls, NY 13153 --- Microlife Corporation 9F, 431, RuiGuang Road, NeiHu, Taipei, 11492, Taiwan, R.O.C. --- Microlife AG Espenstrasse 139 9443 Widnau, Switzerland

    FDA Recall
    Terminated ·Welch Allyn Inc·Product code DXN·February 27, 2017

    CVB distraction screws are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetry Surgical, Millennium Surgical, Medfix International, CareFusion, Boss Instruments, Medline Industries, Surgical Direct, and Teleflex Medical brand names.

    FDA Enforcement
    Class II ·Terminated·Instrumed International, Inc.·December 17, 2014

    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