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510(k) Data Aggregation
K Number
K252593Device Name
LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312)Manufacturer
Date Cleared
2025-09-12
(28 days)
Product Code
Regulation Number
870.1025Type
SpecialPanel
Cardiovascular (CV)Reference & Predicate Devices
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K Number
K252595Device Name
Stethophone ProManufacturer
Date Cleared
2025-09-12
(28 days)
Product Code
Regulation Number
870.1875Type
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Cardiovascular (CV)Reference & Predicate Devices
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K Number
K252562Device Name
Spine & Trauma Navigation InstrumentsManufacturer
Date Cleared
2025-09-12
(29 days)
Product Code
Regulation Number
882.4560Type
SpecialPanel
Orthopedic (OR)Reference & Predicate Devices
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K Number
K252586Device Name
CADDIEManufacturer
Date Cleared
2025-09-12
(28 days)
Product Code
Regulation Number
876.1520Type
SpecialReference & Predicate Devices
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K Number
K252576Device Name
Legend X PlatformManufacturer
Date Cleared
2025-09-12
(29 days)
Product Code
Regulation Number
878.4400Type
SpecialPanel
Neurology (NE)Reference & Predicate Devices
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K Number
K252374Device Name
Nylon flexTAP(R)Manufacturer
Date Cleared
2025-09-11
(43 days)
Product Code
Regulation Number
872.5570Type
SpecialPanel
Dental Devices (DE)Reference & Predicate Devices
N/A
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K Number
K252530Device Name
OptiVu ShoulderManufacturer
Date Cleared
2025-09-10
(30 days)
Product Code
Regulation Number
882.4560Type
SpecialPanel
Orthopedic (OR)Reference & Predicate Devices
N/A
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K Number
K252527Device Name
Surfacer Inside-Out Access Catheter SystemManufacturer
Date Cleared
2025-09-10
(30 days)
Product Code
Regulation Number
870.1342Type
SpecialPanel
Cardiovascular (CV)Reference & Predicate Devices
N/A
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K Number
K252580Device Name
iQ200 SeriesManufacturer
Date Cleared
2025-09-10
(26 days)
Product Code
Regulation Number
864.5200Type
SpecialReference & Predicate Devices
N/A
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K Number
K252477Device Name
Hybrid Viewer (00859873006240)Manufacturer
Date Cleared
2025-09-09
(33 days)
Product Code
Regulation Number
892.1200Type
SpecialPanel
Radiology (RA)Reference & Predicate Devices
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