BEUDAMED
    19 results · 22ms · Sources: EU EUDAMED, US FDA

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    ABX PENTRA TPU CAL, MODEL A11A01898

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MEDCOMP REPAIR KIT, MODEL ASPCRPK

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    BIO-LOGIC CEEGRAPH NETLINK

    FDA 510(k)
    FDA Class 2 ·Neurology

    WAVEWRITER ALPHA 16

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·March 20, 2024

    BDRV CANN SCW SS P/T DIA4.5X60MM

    FDA Adverse Event
    Injury ·BIOMET SPAIN, S.L.·Product code HRS·January 26, 2017

    BDRV CANN SCW SS P/T DIA4.5X52MM

    FDA Adverse Event
    Injury ·BIOMET SPAIN, S.L.·Product code HRS·January 26, 2017

    VERSA-DIAL/COMP TI STD TAPER

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code HSD·April 11, 2018

    COMP PRIMARY STEM 11MM STD

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code HSD·April 11, 2018

    MD HYBRID GLENOID BASE 4MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWS·April 11, 2018

    VERSA-DIAL 50X27X50 HUM HEAD

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code HSD·April 11, 2018

    PT HYBRID GLEN POST REGENEREX

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWS·April 11, 2018

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·May 3, 2013

    PROXIMATE ILS CIRCULAR STAPLER

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·September 16, 2014

    GREENLIGHT ADDSTAT

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·May 2, 2011

    MESH ¿ COMPOSIX L/P

    FDA Adverse Event
    Injury ·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·June 28, 2023

    KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE

    FDA 510(k)
    FDA Class 2 ·Neurology

    cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 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

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024