BEUDAMED
    11 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 ×

    SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    11MM/130 DEG TI CANN TROCH FIXATION NAIL 360MM/LEFT

    FDA Adverse Event
    Injury ·SYNTHES MONUMENT·Product code HSB·February 11, 2016

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040012673·Zirlux 16+ C1 95X25

    INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    COOK IVF CRYOPRESERVATION KIT AND THE COOK IVF THAW KIT

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·March 19, 2013

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    FDA Adverse Event
    Injury ·STAAR SURGICAL COMPANY·Product code HQL·March 9, 2011

    STENOSCOP

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·March 11, 2008

    VEPTR Vertical Expandable Prosthetic Titanium Rib, inferior cradles also known as caudal rib supports. The VEPTR/VEPTR II devices mechanically stabilize and/or correct thoracic deformities to allow the chest and lungs to grow.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·September 9, 2015

    BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

    Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·October 2, 2019