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

MAI 2022-04-08

Bioabsorbable Anchor

Applicant Embody, Inc.

K-Number K213958

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NHA 2022-04-08

TLX SRAs and TLX Gold Abutments

Applicant Institut Straumann AG

K-Number K213063

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MQC 2022-04-08

Thermeo System

Applicant Pro3Dure Medical GmbH

K-Number K212017

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NEU 2022-04-08

SCOUT BX Delivery System

Applicant Merit Medical Systems, Inc.

K-Number K212882

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LNH 2022-04-08

Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR

Applicant Canon Medical Systems Corporation

K-Number K220192

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KRD 2022-04-08

Prestige Coil System

Applicant Bait USA, LLC

K-Number K220699

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FXX 2022-04-07

Comfort Guard Mask, level 1, Comfort Guard Mask, level 3

Applicant Gri-Alleset, Inc.

K-Number K210860

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DPS 2022-04-07

Electrocardiograph

Applicant Edan Instruments, Inc.

K-Number K212278

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NUJ 2022-04-07

Green OR Reprocessed Aquamantys Bipolar Sealer

Applicant Green Or, LLC

K-Number K211203

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NXC 2022-04-07

Invisalign System

Applicant Align Technology, Inc.

K-Number K220287

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LZO 2022-04-07

Corin MetaFix Hip Stem

Applicant Corin U.S.A. Limited

K-Number K212069

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FXX 2022-04-07

Dong Hai Xiang Surgical Mask

Applicant Taizhou Donghaixiang Protective Equipment Co., Ltd.

K-Number K212203

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