BEUDAMED
    24 results · 21ms · 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 ×

    KSEA VASCULAR FIBERSCOPES

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ODYSSEY®

    FDA UDI
    Microport Orthopedics Inc.·M684K00174081·

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092001408·artVeneer life upper anteriors, BIS, C4

    Scanlan® TIP-GUARD™ instrument protectors - Vented

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159002218·Scanlan® TIP-GUARD™ instrument protectors - Ven...

    Battalion

    FDA UDI
    ALPHATEC SPINE, INC.·00840967187990·Battalion, LLIF Trial, 0°, 14 mm Wide, 08 mm X ...

    Intervertebral Disc Preparation Instruments

    FDA UDI
    ALPHATEC SPINE, INC.·00190376380889·LIF, BROACH, CC OFFSET, 14MM X 08MM

    Intervertebral Disc Preparation Instruments

    FDA UDI
    ALPHATEC SPINE, INC.·00190376380490·LIF, BROACH, STRAIGHT, 14MM X 08MM

    COMPCORE AF COMPOSITE CORE BUILD-UP MATERIAL, MODEL 3001408

    FDA 510(k)
    FDA Class 2 ·Dental

    LIFESTYLES, CONTEMPO OR PRIVATE LABEL STRAWBERRY, VANILLA, OR BANANA FLAVORED CONDOM

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

    TEMPTELLER INFRARED EAR THERMOMETER, MODELS TT-901, TT-911 AND TT-921

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ROTARY MIXER

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code MQV·August 29, 2016

    Valence Robotic Navigation System

    FDA UDI
    ALPHATEC SPINE, INC.·00190376646831·BROACH, LIF NAV, STRAIGHT, 14MM X 08MM

    ELITE IGLESIAS BIPOLAR WORKING ELEMENT

    FDA Adverse Event
    Injury ·GYRUS ACMI, INC.·Product code FDC·March 7, 2013

    PT2 GUIDE WIRE

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQX·February 25, 2011

    PUMP, CONTINUOUS WAVE III

    FDA Adverse Event
    Other ·ARTHREX, INC.·Product code HRX·February 20, 2008

    Catalog Number: 9001408 UMBILICAL VESSEL CATHETER KIT Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code LRO·January 7, 2016

    Umbilical Vessel Catheter Kit, Catalog number 900-1408. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code GBN·October 8, 2014

    Umbilical Vessel Catheter Kit, Catalog number 900-1408. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

    FDA Enforcement
    Class I ·Terminated·Customed, Inc·December 10, 2014

    Catalog Number: 9001408 UMBILICAL VESSEL CATHETER KIT Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

    FDA Enforcement
    Class II ·Terminated·Customed, Inc·April 20, 2016

    Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025