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Found 4170 results

510(k) Data Aggregation

K Number

Device Name

Ceribell Instant EEG Headcap (Small: C251, Medium: C252)

Manufacturer

Date Cleared

2025-10-31

(182 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

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K Number

Device Name

Manufacturer

Phasor Health, LLC

Date Cleared

2025-10-31

(122 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

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K Number

Device Name

Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))

Manufacturer

Persyst Development LLC

Date Cleared

2025-10-31

(113 days)

Product Code

OMB,OLT,OLX,OMA

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

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K Number

Device Name

Zoom System (Zoom 4S Catheter)

Manufacturer

Imperative Care, Inc.

Date Cleared

2025-10-30

(122 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

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K Number

Device Name

Medi Lift Essential Eye Mask

Manufacturer

Date Cleared

2025-10-29

(243 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

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K Number

Device Name

TECHFIT Patient-Specific Cranial System

Manufacturer

TECHFIT Digital Surgery Inc.

Date Cleared

2025-10-27

(269 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

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K Number

Device Name

Manufacturer

Wandercraft SAS

Date Cleared

2025-10-24

(212 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

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K Number

Device Name

VersaD Delivery Catheter

Manufacturer

Unity Medical, Inc

Date Cleared

2025-10-24

(175 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

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K Number

Device Name

Carrier XL Delivery Catheter

Manufacturer

Date Cleared

2025-10-22

(69 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

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K Number

Device Name

NeuroAlign software

Manufacturer

Date Cleared

2025-10-21

(846 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

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