BEUDAMED
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    Laser Hair Growth Comb

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    RIGIDFIX

    FDA UDI
    Medos International Sàrl·10886705020096·RIGIDFIX CURVE Femoral Rod Soft Tissue Only 7.5...

    Distal Femur Plate,

    FDA UDI
    I.T.S. GmbH·09120047300299·Distal Femur Plate, 7-Hole, Left

    Spex

    FDA UDI
    SPEX LIMITED·09420051700932·Spex 2 Point Padded Hip Belt, Centre Pull, Side...

    Intelliguides

    FDA UDI
    Mios Marketing, LLC·G2710502130270·1st Met Sagittal Medial Guide, 13mm x 27mm

    SYNGO AORTIC VALVEGUIDE SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Radiology

    MISTER NEB NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS123

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 16, 2011

    JUVEDERM VOLUMA WITH LIDOCAINE 1ML SKU1

    FDA Adverse Event
    Injury ·ALLERGAN·Product code LMH·October 24, 2014

    VITALITY 2

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 9, 2013

    I-STAT CHEM8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·March 16, 2022

    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

    BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers

    FDA Enforcement
    Class II ·Ongoing·Civco Medical Instruments Co. Inc.·June 11, 2025

    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

    18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer  10041227 & 10789400 S1000  10441701 S2000  10041461 S2000 (Refurb) - 10440017 S3000  10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·May 3, 2017