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Found 10395 results

510(k) Data Aggregation

K Number

Validate with FDA (Live)

Device Name

Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300); A.L. One AF Plus OXYGENATOR (US5204); Horizon CVR (US5073)

Manufacturer

Date Cleared

2025-12-12

(269 days)

Product Code

DTZ,DTM,DTN,DTR

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

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K Number

Validate with FDA (Live)

Device Name

Bio Arterial Deluxe (IC-BAP-DX)

Manufacturer

Bio Compression Systems, Inc.

Date Cleared

2025-12-12

(256 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

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K Number

Validate with FDA (Live)

Device Name

Manufacturer

Medicalgorithmics S.A.

Date Cleared

2025-12-11

(77 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

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K Number

Validate with FDA (Live)

Device Name

Sequential Compression System (SCD600)

Manufacturer

Shenzhen Comen Medical Instruments Co.,Ltd

Date Cleared

2025-12-08

(319 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

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K Number

Validate with FDA (Live)

Device Name

HeartBeam AIMIGo with 12-L ECG Synthesis Software System

Manufacturer

Heartbeam, Inc.

Date Cleared

2025-12-08

(314 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

Validate with FDA (Live)

Device Name

MEMO Patch M (MPT-E08R-UNC01)

Manufacturer

Huinno Co., Ltd.

Date Cleared

2025-12-05

(394 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

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K Number

Validate with FDA (Live)

Device Name

MitraPatch Mitral Valve Repair System

Manufacturer

Chawla Heart Technologies, LLC

Date Cleared

2025-12-04

(150 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

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K Number

Validate with FDA (Live)

Device Name

Vektor Computational ECG Mapping System (vMap®)

Manufacturer

Vektor Medical, Inc.

Date Cleared

2025-12-04

(125 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

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K Number

Validate with FDA (Live)

Device Name

IBP cable Becton Dickinson (2606488); IBP cable Edwards (2606489); IBP cable Abbott, Medex (2606490); IBP cable Utah (2606491); IBP Adapter Cable Draeger 7pin (2607558); IBP Adapter Cable Draeger 10pin (2607559)

Manufacturer

Drägerwerk AG & Co, Kgaa

Date Cleared

2025-12-01

(87 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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Device Description

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K Number

Validate with FDA (Live)

Device Name

Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic Catheter

Manufacturer

Surgical Instrument Service and Savings, Inc.

Date Cleared

2025-11-26

(118 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic Catheters are indicated for use to diagnose cardiac arrhythmia.

Device Description

The steerable diagnostic electrode catheters are radiopaque, flexible, insulated catheters with a polymer shaft, each having a mechanical operating mechanism. In each catheter the polymer shaft connects to the catheter handle whereby the curve or loop is actuated by a single pull cable. The Dynamic Tip Catheters have a plunger mechanism, which, when moved forward or back, results in curvature of the distal tip.

AI/ML Overview

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