Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) 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

QJP 2022-10-04

Route 92 Medical Full Length 070 Access System

Applicant Route 92 Medical, Inc.

K-Number K222743

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FMF 2022-10-04

Sterile Hypodermic Syringes for Single Use with Needles

Applicant Sichuan Prius Biotechnology Co., Ltd.

K-Number K221068

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QRL 2022-10-03

Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets

Applicant Owen Mumford, Ltd.

K-Number K221613

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GEX 2022-10-03

Aurolase Therapy, Laser Delivery Device (LDD)

Applicant Nanospectra Biosciences, Inc.

K-Number K202953

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OUR 2022-10-03

SILO TFX MIS Sacroiliac Joint Fixation System

Applicant Aurora Spine, Inc.

K-Number K221047

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FPA 2022-10-03

PCA Syringe Sets

Applicant Baxter Healthcare Corporation

K-Number K212262

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LPH 2022-10-03

ONVOY Acetabular System

Applicant Globus Medical, Inc.

K-Number K213842

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FMK 2022-10-03

Disposable Safety Lancets

Applicant Suzhou Kyuan Medical Apparatus Co., Ltd.

K-Number K221778

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HRS 2022-10-03

Arthrex 2.4 mm Volar Distal Radius Plate System

Applicant Arthrex, Inc.

K-Number K222267

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HRS 2022-10-03

Varixis Elbow System

Applicant Auxein Medical Private Limited

K-Number K213014

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FMK 2022-10-03

Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA)

Applicant Shandong Lianfa Medical Plastic Products Co. , Ltd.

K-Number K222376

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QSW 2022-10-03

Elastic Traction System

Applicant Micro-Tech (Nanjing) Co., Ltd.

K-Number K222354

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