FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

K Number

K253962

Validate with FDA (Live)

Device Name

ClearCheck (RADCC V2.7)

Manufacturer

Radformation, Inc.

Date Cleared

2026-04-03

(113 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

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K Number

K260363

Validate with FDA (Live)

Device Name

Ceribell Brain Monitor Headband

Manufacturer

Ceribell, Inc.

Date Cleared

2026-04-03

(58 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

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K Number

K253076

Validate with FDA (Live)

Device Name

Cryopush Cold Compression Device (A02-P-001)

Manufacturer

Chengdu Cryo-Push Medical Technology Co.,Ltd

Date Cleared

2026-04-02

(191 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

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K Number

K254015

Validate with FDA (Live)

Device Name

CoLumbo C-Spine

Manufacturer

Smart Soft Healthcare AD

Date Cleared

2026-04-01

(107 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

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K Number

K260257

Validate with FDA (Live)

Device Name

CO2 Laser System

Manufacturer

Sanhe Meditech Co., Ltd.

Date Cleared

2026-03-28

(59 days)

Product Code

GEX

Regulation Number

878.4810

Type

Traditional

Panel

General & Plastic Surgery

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

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K Number

K253270

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Device Name

Contour ProtégéAI+

Manufacturer

Mim Software, Inc.

Date Cleared

2026-03-27

(179 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

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K Number

K254239

Validate with FDA (Live)

Device Name

CyClean Cord

Manufacturer

SS GLOBAL

Date Cleared

2026-03-27

(88 days)

Product Code

MVL

Regulation Number

N/A

Type

Traditional

Panel

Dental

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

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K Number

K252037

Validate with FDA (Live)

Device Name

CUVIS-joint (CJ150)

Manufacturer

Curexo, Inc.

Date Cleared

2026-03-25

(268 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

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K Number

K252992

Validate with FDA (Live)

Device Name

CT Rembra RT; CT Areta RT; CT Rembra

Manufacturer

Philips Healthcare (Suzhou) Co., Ltd.

Date Cleared

2026-03-23

(186 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

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K Number

K254288

Validate with FDA (Live)

Device Name

Clavicle Fixation System

Manufacturer

Skeletal Dynamics, Inc.

Date Cleared

2026-03-23

(82 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

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510(k) Data Aggregation