BEUDAMED
    23 results · 38ms · 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 ×

    BREAST SPEEDER CX, GRID HOLDER CX

    FDA 510(k)
    FDA Class 2 ·Radiology

    Equator

    FDA UDI
    Preat Corporation·00842092181799·Equator Abutment for Astra TX 3.0 x 2mm

    HIGHLIGHT

    FDA UDI
    Richard Wolf GmbH·04055207012901·LIGHT SOURCE X 300 300W Xenon short arc lamp, ...

    LACTOSORB® SYSTEM

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036053826·

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694026420·MFx Angulated Locking BSSO Plate, 4 Hole, Long

    BD BBL MGIT MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code MDB·September 16, 2021

    TALYMED

    FDA 510(k)
    FDA Unclassified ·Unknown

    SYNESCOPE, EASYSCOPE, SYNECOM, HOLTERREADER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MINIMED QUICK-SET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL UM-D·Product code FPA·April 9, 2025

    ENDOSCOPIC LIGHT SOURCE

    FDA Adverse Event
    Malfunction ·RICHARD WOLF GERMANY (GMBH)·Product code GCT·March 20, 2017

    PARADIGM INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LZG·October 4, 2014

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·June 28, 2011

    SOFTCLIX ® LANCET DEVICE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·June 3, 2013

    FUSION DESIGN

    FDA Adverse Event
    Injury ·RICHARD WOLF GMBH·Product code GCT·October 1, 2021

    Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG

    FDA Enforcement
    Class II ·Ongoing·ICU Medical Inc.·January 21, 2026

    PKG, CLAW FORCEPS, P/N 0250080244. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    GEM DR Model 7271 Implantable Cardioverter-Defibrillator (ICD)

    FDA Recall
    Open, Classified ·November 14, 2002

    C1406, QLC1406, C1473, and QLC1473 Quick Connect for Olympus 30/40/160/200/240 Series Bronchoscopes in the C1140 Universal Processing Trays. Catalog numbers: C11473 and QLC1473.

    FDA Recall
    Terminated ·Steris Corp·Product code MLR·March 7, 2003

    Microlab AT, part numbers 135001, 135001OOC, 135002, 135003, 135005, 135006, 135006R, 135007, 135008, 135016, 135028, 135029, 936400, 936400BLU. Microlab AT+ and Microlab AT+2, part numbers 142000, 142001, 142001R, 142002, 142003, 142005, 142006, 142006R, 142007, 142008, 142009, 142015, 142017, 142035, 142036

    FDA Recall
    Terminated ·Hamilton Co·Product code JTC·December 13, 2005

    Solar 8000M Patient Monitor with software versions 3A, 3B and 3C

    FDA Recall
    Terminated ·General Electric Medical Systems Information Technology·Product code DSI·June 14, 2002