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

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    IR WIRELESS FOOT SWITCH

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    JOBST forMen

    FDA UDI
    BSN MEDICAL, INC.·04042809843750·FOR MEN 30-40 MM HG KNEE HIGH CLOSED TOE LARGE ...

    Ophthalmic Forceps

    FDA UDI
    KATENA PRODUCTS, INC.·00841668106440·BISHOP-HARMON FORCEPS STANDARD

    POINT 4 MODIFIED

    FDA 510(k)
    FDA Class 2 ·Dental

    INSTATRAK SYSTEM WITH FLUOROCAT, MODEL IT3500

    FDA 510(k)
    FDA Class 2 ·Radiology

    UNIDENTIFIED GLENOID PEG

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS·Product code KWS·April 11, 2013

    EASYTRAK 2

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code OJX·April 13, 2011

    MBT TRAY SLEEVE POR M/L 37MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code HRY·May 27, 2008

    I-STAT CHEM8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·February 15, 2022

    I-STAT CARTRIDGE

    FDA Adverse Event
    Injury ·ABBOTT POINT OF CARE·Product code CHL·August 8, 2014

    OSS POLY LOCK PIN

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·September 27, 2017

    OSS 3CM DIAPHYSEL SEGMENT

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·September 27, 2017

    PFC*SIGMA C/R NPOR FEM LT SZ5

    FDA Adverse Event
    Malfunction ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JWH·April 10, 2019

    OSS RS 7 CM MOD SEG FMRL-LT

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KRO·September 27, 2017

    OSS SEGMENTAL STACKING ADAPTER

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·September 27, 2017

    OSS POROUS IM STEM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·September 27, 2017

    i-STAT CHEM 8+ Cartridge, List Number 03P91-25; 510 K053110 Useful for monitoring a variety of conditions. The panel of tests is used in the hospital environment to assess kidney function, electrolyte status, acid/base balance, and blood sugar level. This test panel is also used to assess hypertension and hypokalemia.

    FDA Recall
    Terminated ·Abbott Point Of Care Inc.·Product code JGS·February 15, 2011

    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

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction and QRS duration > or equal to 120 ms. This family of pulse generators provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014