Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

LLZ 2023-09-20

Rology Teleradiology Platform (v.1.22.1103)

Applicant Rology, Inc.

K-Number K231385

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HIF 2023-09-20

Insufflator (OPTO-IFL1000)

Applicant Guangdong Optomedic Technologies, Inc.

K-Number K231342

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PBF 2023-09-20

MedCAD AccuPlan Orthopedics System

Applicant Medcad

K-Number K223421

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JAK 2023-09-19

Aquilion Serve (TSX-307A/1) V1.3

Applicant Canon Medical Systems Corporation

K-Number K231281

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QJP 2023-09-19

Q Distal Access Catheter

Applicant Mivi Neuroscience, Inc.

K-Number K222948

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KPR 2023-09-19

GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series)

Applicant DRGEM Corporation

K-Number K232178

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QJP 2023-09-19

Millipede 088 Access Catheter

Applicant Perfuze, Ltd.

K-Number K231802

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FZP 2023-09-19

angiOCCLUDE Ligating Clips

Applicant A2 Medical Systems, LLC

K-Number K230966

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JOY 2023-09-19

AI100 with Shonit

Applicant Sigtuple Technologies Pvt. , Ltd.

K-Number K221309

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MSS 2023-09-19

Accuject Refra Injector AR2900

Applicant Medicel AG

K-Number K231106

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LRK 2023-09-18

The AVEOtsd (Tongue Stabilizing Device) Mouthpiece

Applicant Innovative Health Technologies (Nz), Ltd.

K-Number K231663

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QTD 2023-09-18

Apollo ESG NXT System, Apollo REVISE NXT System

Applicant Apollo Endosurgery, Inc.

K-Number K232544

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