3,165 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORP.·Product code GCJ·September 23, 2021
Signia
FDA UDI
Ws Audiology Usa, Inc.·04056839070659·Signia S_ITE CROS SILK NX R MOC TRD Hearing Aid
Signia
FDA UDI
Ws Audiology Usa, Inc.·04056839070710·Signia S_ITE CROS SILK NX R BLK TRD Hearing Aid
XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·May 23, 2013
5 FR. D/L GROSHONG NXR W/MI AND TLS
FDA Adverse Event
Death
·C. R. BARD INC. (BASD)·Product code LJS·December 24, 2008
Fixation, Vision Training, Binocular
FDA classification
FDA Class 1
·Fixation, Vision Training, Binocular
NJR MEDICAL, INC.
FDA registration
NJR MEDICAL, INC.·1 product·🇺🇸 United States
NAR Medical Depot, LLC
FDA registration
NAR Medical Depot, LLC·10 products·🇺🇸 United States
HoloXR Health Connect
FDA UDI
Holoray Inc.·G721HXR0·The HoloXR Health Connect is an adjunctive tool...
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
Master-Bilt
FDA UDI
NOR-LAKE, INCORPORATED·00851714007171·
Norlake
FDA UDI
NOR-LAKE, INCORPORATED·00851714007072·
Norlake
FDA UDI
NOR-LAKE, INCORPORATED·00851714007003·
Norlake
FDA UDI
NOR-LAKE, INCORPORATED·00851714007041·
Norlake
FDA UDI
NOR-LAKE, INCORPORATED·00851714007065·
Norlake
FDA UDI
NOR-LAKE, INCORPORATED·00851714007034·
Norlake
FDA UDI
NOR-LAKE, INCORPORATED·00851714007027·
Master-Bilt
FDA UDI
NOR-LAKE, INCORPORATED·00851714007164·
Norlake
FDA UDI
NOR-LAKE, INCORPORATED·00851714007089·