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

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    FORTRESS PEDICLE SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PIVOX™ Oblique Lateral Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00763000878559·INSERTER 2140010 OLIF25 PLATE-CAGE

    PIVOX™ Oblique Lateral Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169639522·INSERTER 2140010 OLIF25 PLATE-CAGE

    MobiCath™

    FDA UDI
    Greatbatch Ltd·00846835012388·Bi-Directional Guiding Sheath, Small Curve

    MOBICATH™

    FDA UDI
    Greatbatch Ltd·00821329400995·MOBICATH™ Bi-Directional Guiding Sheath, Small ...

    Encompass Hip Stem

    FDA UDI
    Ortho Development Corporation·00822409012800·10mm Distal Centralizer

    PAQ.178X300X1000/EEG/140010

    FDA UDI
    AB MEDICA GROUP, S.A.·08428763006428·

    ZEUS-O

    FDA UDI
    SPINAL ELEMENTS·00840606151412·ZEUS®-O 10MM DILATOR

    N.A.

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR21021400101·Compound retraction arch mand. .016"x.022" / 30°

    STERILE SPINE ACP SYSTEM

    FDA UDI
    Wishbone Medical, Inc.·B562ACP756140010US0·Sterile Spine ACP Screw, FA/SD, Ø4.0x10 mm

    STERILE SPINE ACP SYSTEM

    FDA UDI
    Wishbone Medical, Inc.·B562ACP755140010US0·Sterile Spine ACP Screw, VA/SD, Ø4.0x10 mm

    HDL CHOLESTEROL (HDLX) ASSAY

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    GENESIS MEDICAL INTERVENTIONAL F.A.S.T. (FACILITATED ASPIRATION/SUCTION THROMBECTOMY) SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACCU-CHEK ® INSIGHT FLEX INFUSION SET

    FDA Adverse Event
    Malfunction ·ROCHE DIABETES CARE, INC.·Product code FPA·March 29, 2017

    PIVOX¿ OBLIQUE LATERAL SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code MAX·February 8, 2025

    Drug-Eluting Peripheral Transluminal Angioplasty Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter and IN.PACT 018 Paclitax

    TELIGEN

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 3, 2014

    TRILOGY 200

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC·Product code CBK·May 28, 2013

    PK7300 AUTOMATED MICROPLATE SYSTEM

    FDA Adverse Event
    BECKMAN COULTER MISHIMA K.K.·Product code KSZ·June 25, 2011

    Biosense Webster MobiCath Bi-Directional Guiding Sheath, Model D140010 (small curve) and D140011 (large curve). The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneous catheter introducer (or guiding sheath) designed for gaining access to the coronary systems. The device features adjustable tip geometry through use of a rotating handle to deflect the catheter. This catheter is assembled with a hemostasis valve and a sideport infusion line. The kit includes a flexible catheter dilator to facilitate bi-directional guiding sheath passage.

    FDA Enforcement
    Class II ·Terminated·Greatbatch Medical·August 9, 2017