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

ODP 2021-04-23

GPS Cervical Spacers

Applicant G Surgical, LLC

K-Number K210890

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FRG 2021-04-23

SIGMA Sterilization Pouch and Roll

Applicant Sigma Medical Supplies Corporation

K-Number K202462

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LIT 2021-04-23

SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter

Applicant Cordis Corporation

K-Number K210626

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FXX 2021-04-23

Naton Disposable Surgical Face Mask

Applicant Naton Biotechnology (Beijing) Co., Ltd.

K-Number K201853

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JEC 2021-04-23

SteriTrak

Applicant Arbutus Medical, Inc.

K-Number K203605

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DQA 2021-04-23

Pulse Oximeter

Applicant Shenzhen Hexin Zondan Medical Equipment Co., Ltd.

K-Number K203854

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PGY 2021-04-23

2MP Monochrome LCD Monitor MS-S200

Applicant Jvckenwood Corporation

K-Number K210345

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FXX 2021-04-23

Face Mask

Applicant Jinhua Jingdi Medical Supplies Co., Ltd.

K-Number K210007

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FXX 2021-04-23

Surgical Mask - Level 3 - Blue - 50 pcs, Surgical Mask - Level 3 - White - 50 pcs, Procedure Mask - Level 3 - Blue - 50 pcs, Procedure Mask - Level 3 - White - 50 pcs

Applicant String King Lacrosse, LLC

K-Number K202607

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HGI 2021-04-23

IRIS Thermocoagulator and Digital Colposcope

Applicant Liger Medical, LLC

K-Number K202915

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INI 2021-04-23

Solax Electric Scooter

Applicant Dongguan Prestige Sporting Goods Co., Ltd.

K-Number K192190

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NRY 2021-04-23

ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing

Applicant Imperative Care, Inc.

K-Number K210996

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