BEUDAMED
    16 results · 22ms · 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 ×

    DENALI SPINE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CD HORIZON® Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00885074032474·BONE SCREW 7042635 20 DEG ILC 6.5X35 TI

    JOBST forMen

    FDA UDI
    BSN MEDICAL, INC.·04042809866643·FOR MEN 30-40 MM HG THIGH MICRO DOT BAND OPEN T...

    REPROCESSED STRYKER ARTHROSCOPIC SHAVERS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    KUSKE BREAST APPLICATOR SET, MODEL 189.006

    FDA 510(k)
    FDA Class 2 ·Radiology

    MATRIXNEURO STERILE KIT STD 4

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code JEY·December 19, 2013

    TI MATRIXNEURO BURR HOLE COVER24MM

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code JEY·October 28, 2015

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 4, 2013

    OT ULTRA METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·April 6, 2011

    ATRIAL J SELUTE PICOTIP

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS, INC·Product code DTB·May 8, 2008

    MATNEU SCR Ø1.5 SELF-DRILL L4 TAN 1U I/C

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HWC·June 23, 2013

    MATNEU SCR Ø1.5 SELF-DRILL L4 TAN 4U I/C

    FDA Adverse Event
    Malfunction ·SYNTHES BETTLACH·Product code JEY·August 28, 2015

    NCB, DF PLATE, RIGHT, 13 HOLES, 324 MM

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code HRS·June 11, 2018

    PKG, NEEDLE NOSE FORCEPS, P/N 0250080288. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD Inc.·December 18, 2019

    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