BEUDAMED
    14 results · 21ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    BICARBONATE DIALYSATE CONCENTRATE MIXER, MODEL 50 GALLON & 100 GALLON

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

    HAMILTON MEDICAL AG

    FDA Adverse Event
    Malfunction ·HAMILTON MEDICAL AG·Product code CBK·July 6, 2023

    BINAX NOW STREPTOCOCCUS PNEUMONIAE TEST

    FDA 510(k)
    FDA Class 1 ·Microbiology

    SPARTAN MTS

    FDA 510(k)
    FDA Class 2 ·Dental

    3022521-2015-00002

    FDA Adverse Event
    August 18, 2015

    SQUARE SCREWDRIVER

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·November 26, 2019

    AMISTEM H FEMORAL STEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL, SA·Product code LZO·March 21, 2013

    INRATIO

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·February 15, 2011

    IRRIGATION CATHETER, 4F, 80CM

    FDA Adverse Event
    Other ·APPLIED MEDICAL RESOURCES·Product code GBX·March 24, 2008

    EVOLIS MICROPLATE SYSTEM

    FDA Adverse Event
    Injury ·BIO-RAD LABORATORIES·Product code JJE·May 5, 2017

    RECON SCREW LG 5.5MM DIA and M/DN FEM IM NAIL 8MM DIA to 16 MM DIA. Item codes starting with 0022520, 0022521, 002522, 0022523, 0022524 and 0022525.

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code HSB·October 11, 2013

    RECON SCREW LG 5.5MM DIA and M/DN FEM IM NAIL 8MM DIA to 16 MM DIA. Item codes starting with 0022520, 0022521, 002522, 0022523, 0022524 and 0022525.

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·February 26, 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 2110. 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