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

FYA 2022-03-04

Surgical Gown

Applicant Wujiang Tutaike Textiles & Finishing Co., Ltd.

K-Number K213703

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OBP 2022-03-04

BTL-995-rTMS

Applicant BTL Industries, Inc.

K-Number K212723

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MOS 2022-03-03

OR Head Holder LUCY with HeadCoilSet Siemens 1.5T, OR Head Holder LUCY with HeadCoilSet Siemens 3T, OR Head Holder LUCY with HeadCoilSet Philips 1.5T, OR Head Holder LUCY with HeadCoilSet Philips 3T

Applicant Noras Mri Products GmbH

K-Number K211658

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NUC 2022-03-03

Astroglide Sensual Strawberry Personal Lubricant

Applicant Biofilm, Inc.

K-Number K213671

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IRP 2022-03-03

Air Compression Leg Massager (model: FE-7204B)

Applicant Xiamen Healthpal Electronic Co.,Ltd

K-Number K211850

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NUH 2022-03-03

TENS & EMS Device

Applicant Shenzhen Jian Feng Electronic Technology Co., Ltd.

K-Number K213835

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LNH 2022-03-03

Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi Nudclei

Applicant Philips Medical Systems Nederland B.V.

K-Number K213516

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NHA 2022-03-03

Osteon Precision Milled Suprastructure

Applicant Implant Solutions Pty Ltd (Osteon Medical)

K-Number K212676

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PKL 2022-03-03

Hemoclip

Applicant Hangzhou AGS MedTech Co., Ltd.

K-Number K211787

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LLZ 2022-03-03

nordicDSC

Applicant Nordicneurolab AS

K-Number K212720

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KWQ 2022-03-03

IMPEACE and IMPEACE-Uni Anterior Cervical Plate System

Applicant Medynus, Inc.

K-Number K220379

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GZI 2022-03-03

MyndMove 2.0

Applicant Myndtec, Inc.

K-Number K212149

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