BEUDAMED
    17 results · 19ms · 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 ×

    TACTIX Vector Syndesmosis System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Gyrus ACMI

    FDA UDI
    Gyrus ACMI, LLC·00821925032101·SHEA PARASOL VENT TUBE SMALL 1 MM ID SILICONE

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694007559·Hemi Mesh, Right Mandible/Left Maxilla, 16mm

    SacroFuse

    FDA UDI
    SPINEFRONTIER, INC.·00190361023296·Ø8MM FUSION SCREW, GEN II, SACROFUSE, 35MM

    rematitan®

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011240035000·rematitan® attachment Male part casing

    Agent, Absorbable Hemostatic, Collagen With Polymeric Additives

    FDA Pre-Market Approval
    FDA Class 3 ·ETHIZIA

    ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Spinema Lumbar Plate System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Ultravision Visual Field Clearing System

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

    Agent, Absorbable Hemostatic, Collagen With Polymeric Additives

    FDA Pre-Market Approval
    FDA Class 3 ·ETHIZIA™ Hemostatic Patch

    Agent, Absorbable Hemostatic, Collagen With Polymeric Additives

    FDA Pre-Market Approval
    FDA Class 3 ·ETHIZIA Hemostatic Patch

    Agent, Absorbable Hemostatic, Collagen With Polymeric Additives

    FDA Pre-Market Approval
    FDA Class 3 ·ETHIZIA™ Hemostatic Patch

    Agent, Absorbable Hemostatic, Collagen With Polymeric Additives

    FDA Pre-Market Approval
    FDA Class 3 ·ETHIZIA™ Hemostatic Patch

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·October 26, 2023

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE INC.·Product code LZG·October 29, 2014

    TENDRIL SDX

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·September 8, 2011

    PELVILACE TO BIOURETHRAL SUPPORT SYSTEM

    FDA Adverse Event
    Injury ·TISSUE SCIENCE LABORATORIES·Product code FTL·July 18, 2013

    MOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer (8cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195028 MS-00009 (Pack of 10) - MOLLI Introducer (12cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195134 MP2001 - MOLLI 2 Wand UDI (GTIN): 00850024195141 MP2015A - MOLLI OncoPen UDI (GTIN): 00850024195219 MT2001 - MOLLI 2 Tablet UDI (GTIN): 00850024195158 The MOLLI Marker is intended to be placed percutaneously in soft tissue to temporarily mark a surgical site intended for surgical removal. the MOLLI Marker is located and surgically removed with the target tissue.

    FDA Enforcement
    Class II ·Ongoing·Stryker Corporation·February 25, 2026