BEUDAMED
    15 results · 20ms · 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 ×

    COMPRESS DISTAL FEMORAL REPLACEMENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SOAR Retractor System

    FDA UDI
    SPINEOLOGY INC.·M7403031804·18MM X 40MM Tube

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0310040·Probe, 1.5 inch Ball, Lenke, Straight, Black

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0315040·Probe, 1.5 inch Ball, Lenke, Straight, Impaction

    NUMED Z-5 ATRIOSEPTOSTOMY CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CAPIOX ARTERIAL FILTER WITH X-COATING, PRODUCT CODE CX*AFO2X

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MATRIXMANDIBLE SHORT CUT PLATE CUTTER

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HTZ·April 2, 2013

    POWER PRO AMBULANCE COT

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code INK·February 25, 2011

    UNKNOWN DEPUY PATELLA

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code HTG·April 17, 2008

    AxSYM CA 125 Reagent Pack, list 3B41-22 and IMx CA 125 Reagent Pack, list 7A89-22; 100 test kits; Abbott Laboratories, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Laboratories HPD/ADD/GPRD·Product code LTK--·November 25, 2003

    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

    The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·March 23, 2016

    Spirit Plus Bed, A-C Powered Hospital Bed

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

    Spirit Select Bed, A-C Powered Hospital Bed

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

    Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option. Product Usage: The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. Physiological parameters that may be monitored include ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (Sp02) and cardiac output. Acquired data may then be communicated to all information network for display, recording, editing and analysis.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 6, 2015