BEUDAMED
    23 results · 26ms · 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 ×

    REFRACTIVE SURGERY BLADES

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    Scanlan® SURG-I-BAND® color coding

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159001617·Scanlan® SURG-I-BAND® color coding - Labels-Sol...

    Battalion

    FDA UDI
    ALPHATEC SPINE, INC.·00840967147895·BATTALION, LLIF BROACH, STRAIGHT, 18MM X 06MM

    Battalion

    FDA UDI
    ALPHATEC SPINE, INC.·00190376004273·BATTALION, LLIF PRIMARY DISTRACTOR, 1/4" SQ. ST...

    Battalion

    FDA UDI
    ALPHATEC SPINE, INC.·00840967188317·Battalion, LLIF Trial, 0°, 18 mm Wide, 06 mm X ...

    THERATRON 780C/1000 WITH COMPUTERIZED CONSOLE UPGRADE

    FDA 510(k)
    FDA Class 2 ·Radiology

    KARL STORZ HYSTEROMAT II

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

    AUTOSOFT XC

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·August 12, 2024

    General Instruments

    FDA UDI
    ALPHATEC SPINE, INC.·00811801036323·18x45 Distractor Rasp – 6mm

    General Instrument

    FDA UDI
    ALPHATEC SPINE, INC.·00840180509975·LLIF DISTRACTOR PARTIAL RASP, 1/4" SQ., 18MM X ...

    Intervertebral Disc Preparation Instruments

    FDA UDI
    ALPHATEC SPINE, INC.·00190376380735·LIF, BROACH, STRAIGHT, 18MM X 06MM

    General Instruments

    FDA UDI
    ALPHATEC SPINE, INC.·00811801036361·18x45 Distractor Rasp – 6mm, Offset

    Intervertebral Disc Preparation Instruments

    FDA UDI
    ALPHATEC SPINE, INC.·00190376381121·LIF, BROACH, CC OFFSET, 18MM X 06MM

    General Instruments

    FDA UDI
    ALPHATEC SPINE, INC.·00811801033315·Lateral Distractors - 20mm taper, 18 x 6

    Valence Robotic Navigation System

    FDA UDI
    ALPHATEC SPINE, INC.·00190376647081·BROACH, LIF NAV, STRAIGHT, 18MM X 06MM

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    FDA Adverse Event
    LAND AMERICA HEALTH & FITNESS·Product code FNL·March 13, 2013

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·February 3, 2011

    COAGUCHEK XS SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·February 19, 2008

    TC-PLUS Tibial Insert UC 6; 13mm, Model 25438

    FDA Recall
    Terminated ·Plus Orthopedics USA·Product code JWH·August 3, 2005

    bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025