BEUDAMED
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    UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS MAHWAH·Product code JWH·July 13, 2010

    SURGITEK

    FDA Adverse Event
    Injury ·SURGITEK·Product code FTR·July 25, 2000

    PORTEX

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code BXR·September 19, 2022

    PORTEX PNEUPAC VENTILATOR SUPPORT GAUGE

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code BXR·April 27, 2023

    INSPIRATORY FORCE MONT KIT/MANIFOLD/METER/TUBING

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code BXR·September 19, 2022

    RESPIRATORY FORCE MEASURING

    FDA Adverse Event
    Malfunction ·RUSCH INC.·Product code BXR·November 27, 2002

    PORTEX PRESSUREEASY CUFF PRESSURE MONITOR

    FDA Adverse Event
    Malfunction ·ST PAUL·Product code BXR·March 23, 2022

    Meter, Airway Pressure (Inspiratory Force)

    FDA classification
    FDA Class 2 ·Meter, Airway Pressure (Inspiratory Force)

    Endoplus

    FDA UDI
    Endoplus·00817401028089·5mm Axial Non-Locking Handle with Rotation, Sta...

    BMR Medical

    FDA registration
    BMR Medical·1 product·🇧🇷 Brazil

    BPR MEDICAL LIMITED

    FDA registration
    BPR MEDICAL LIMITED·5 products·🇬🇧 United Kingdom

    SMOOTH-BOR PLASTICS

    FDA registration
    SMOOTH-BOR PLASTICS·3 products·🇺🇸 United States

    HCS

    FDA UDI
    DYAD MEDICAL SOURCING, LLC·00849027003928·O.R. Towel, 100% Cotton, Blue, Single Use, Pre-...

    HCS

    FDA UDI
    Concordance Healthcare Solutions LLC·00810132041044·O.R. Towel, 100% Cotton, Blue, Single Use, Pre-...

    HCS

    FDA UDI
    DYAD MEDICAL SOURCING, LLC·00849027002259·OR Towel 17" x 26"

    HCS

    FDA UDI
    Concordance Healthcare Solutions LLC·00810132040610·O.R. Towel, 100% Cotton, Blue, Single Use, Pre-...

    Instrument B2R

    FDA UDI
    W & H Dentalwerk Bürmoos GmbH·J021069586001·Piezomed Accessories

    BOR JYE ENTERPRISE CO., LTD.

    FDA registration
    BOR JYE ENTERPRISE CO., LTD.·3 products·🇹🇼 Taiwan

    Medline Neuro Sponges, various dimensions, labeled as: 1. Neuro Sponges, Eponges neuro, Neuroesponjas, size 0.25" X 0.25", XR, 10/PK, Medline SKU NEUROSPNG02; 2. Neuro Sponges, Eponges neuro, Neuroesponjas, size 0.5" X 0.5", XR, 10/PK, Medline SKU NEUROSPNG05; 3. Neuro Sponges, Eponges neuro, Neuroesponjas, size 0.5" X 1", XR, LF, 10/PK, Medline SKU NEUROSPNG06; 4. Neuro Sponges, Eponges neuro, Neuroesponjas, size 0.5" X 1.5", XR, LF, 10/PK, Medline SKU NEUROSPNG07; 5. Neuro Sponges, Eponges neuro, Neuroesponjas, size 0.5" X 3", XR, LF, 10/PK, Medline SKU NEUROSPNG09; 6. Neuro Sponges, Eponges neuro, Neuroesponjas, size .75" X .75", XR, LF, 10/PK, Medline SKU NEUROSPNG11; 7. Neuro Sponges, Eponges neuro, Neuroesponjas, size 1" X 1", XR, LF, 10/PK, Medline SKU NEUROSPNG13; 8. Neuro Sponges, Eponges neuro, Neuroesponjas, size 1" X 3", XR, LF, 10/PK, Medline SKU NEUROSPNG14.

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·May 6, 2026

    Medline Neuro Sponges, various dimensions, labeled as: 1. Neuro Sponges, Eponges neuro, Neuroesponjas, size 0.25" X 0.25", XR, 10/PK, Medline SKU NEUROSPNG02; 2. Neuro Sponges, Eponges neuro, Neuroesponjas, size 0.5" X 0.5", XR, 10/PK, Medline SKU NEUROSPNG05; 3. Neuro Sponges, Eponges neuro, Neuroesponjas, size 0.5" X 1", XR, LF, 10/PK, Medline SKU NEUROSPNG06; 4. Neuro Sponges, Eponges neuro, Neuroesponjas, size 0.5" X 1.5", XR, LF, 10/PK, Medline SKU NEUROSPNG07; 5. Neuro Sponges, Eponges neuro, Neuroesponjas, size 0.5" X 3", XR, LF, 10/PK, Medline SKU NEUROSPNG09; 6. Neuro Sponges, Eponges neuro, Neuroesponjas, size .75" X .75", XR, LF, 10/PK, Medline SKU NEUROSPNG11; 7. Neuro Sponges, Eponges neuro, Neuroesponjas, size 1" X 1", XR, LF, 10/PK, Medline SKU NEUROSPNG13; 8. Neuro Sponges, Eponges neuro, Neuroesponjas, size 1" X 3", XR, LF, 10/PK, Medline SKU NEUROSPNG14.

    FDA Recall
    Open, Classified ·Product code HBA·March 19, 2026