BEUDAMED
    19 results · 28ms · Sources: EU EUDAMED, US FDA

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    QUICKPROFILE SINGLE DRUG OF ABUSE DEVICE AND QUICK PROFILE MULTI-DRUGS OF ABUSE SCREEN DEVICE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    NUPRO®

    FDA UDI
    Dentsply Professional·D0031302131·NUPRO® 5% Sodium Fluoride White Varnish, Patien...

    EVONOS

    FDA UDI
    Gyrus ACMI, LLC·00821925013100·SCHUKNECHT MODIFIED HOUGH ELEVATOR, RT

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694031530·1.6mm Modified LeFort Plate, Right, 8mm

    Distal Femur Plate

    FDA UDI
    I.T.S. GmbH·09120034307089·Distal Femur Plate, 13-Hole, Left

    N/A

    FDA UDI
    Tyber Medical, LLC·M695M1302130·

    ONLINE DAT II CANNABINOIDS II

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    LUMANOSITY CELEBRITY, MODEL 204

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAT·September 28, 2018

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAW·September 28, 2018

    AVALON ELITE

    FDA Adverse Event
    Injury ·AVALON LABORATORIES LLC·Product code DWF·August 26, 2010

    I.T.S. LRS (Locking Reconstruction System) with the below descriptions and corresponding article numbers. 1. DFL (Distal Femur Locking) Distal Femur Plate; Article Numbers: 21301-5, 21301-7, 21301-9, 21301-13, 21302-5, 21302-7, 21302-9, 21302-13. 2. PTL (Proximal Lateral Tibia Locking) Proximal Lateral Tibia Plate; Article Numbers: 21321-7, 21321-12, 21322-7, 21322-12. 3.PTL (Proximal Lateral Tibia Locking) Proximal Medial Tibia Plate; Article Numbers: 21325-4, 21325-7.

    FDA Enforcement
    Class II ·Ongoing·I.T.S. GmbH·April 1, 2026

    TRAUMA KIT: 8.5 FR

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC.·Product code DQY·May 22, 2013

    2.5MM PERCUTANEOUS DRILL BIT QC/300MM/200MM CALIBRATION

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HTW·September 30, 2014

    MILAGRO INTERFERENCE SCREW

    FDA Adverse Event
    Injury ·DEPUY MITEK·Product code HWC·June 16, 2011

    BD EMERALD¿ 2ML SYRINGE, LUER SLIP CENTRIC TIP

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·October 6, 2017

    I.T.S. LRS (Locking Reconstruction System) with the below descriptions and corresponding article numbers. 1. DFL (Distal Femur Locking) Distal Femur Plate; Article Numbers: 21301-5, 21301-7, 21301-9, 21301-13, 21302-5, 21302-7, 21302-9, 21302-13. 2. PTL (Proximal Lateral Tibia Locking) Proximal Lateral Tibia Plate; Article Numbers: 21321-7, 21321-12, 21322-7, 21322-12. 3.PTL (Proximal Lateral Tibia Locking) Proximal Medial Tibia Plate; Article Numbers: 21325-4, 21325-7.

    FDA Recall
    Open, Classified ·I.T.S. GmbH Autal 28 Lasnitzhohe Austria·Product code HRS·January 23, 2026

    Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·September 30, 2015

    NeuRx Diaphragm Pacing System (NeuRx DPS), Affected part numbers: Part # Part Name 20-0035 NeuRx DPS System Kit 20-0036 NeuRx Diaphragm Pacing System, Patient Kit, SCI 20-0028 NeuRx DPS Surgical Kit, HDE 20-0040 NeuRx Diaphragm Pacing System Spare Sterile Components 21-0001-99 Mapping Probe 21-0004-99 Indifferent Electrode 21-0007-99 Lead Tunneler Set 21-0009-99 Blue Cable Set 21-0010-99 Transducer Tubing 21-0017-99 PermaLoc Electrode 21-0023-99 Green Cable 21-0024-99 Orange Cable 21-0025-99 Yellow Cable 21-0026-99 White Cable 77-0050 Surgeon Instruction Manual 20-0045 NeuRx DPS System Kit, ALS HDE 20-0046 NeuRx Diaphragm Pacing System, Patient Kit, ALS Marketed under HDE H070003 as well as H100006

    FDA Enforcement
    Class III ·Terminated·Synapse Biomedical Inc·July 27, 2022