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

ETN 2022-03-21

NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long

Applicant Medtronic Xomed, Inc.

K-Number K213246

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MNR 2022-03-21

WatchPAT200U (WP200U)

Applicant Itamar Medical , Ltd.

K-Number K203839

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HRS 2022-03-21

AFFINITY Proximal Tibia System

Applicant Techfit Digital Surgery, Inc.

K-Number K220199

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OHS 2022-03-18

LYMA Laser

Applicant Lyma Life , Ltd.

K-Number K210823

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CJW 2022-03-18

Albumin BCP2

Applicant Abbott Ireland Diagnostics Division

K-Number K203530

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OVD 2022-03-18

Stable-L Standalone Lumbar Interbody System

Applicant Nexus Spine, LLC

K-Number K212498

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KDJ 2022-03-18

15L Cycler Drainage Bag

Applicant Baxter Healthcare Corporation

K-Number K214016

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LZA 2022-03-18

Powder Free Nitrile Examination Gloves, Blue and Violet Blue, Test For Use With Chemotherapy Drugs

Applicant Shandong Blue Sail Health Technology Co., Ltd.

K-Number K220228

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FLL 2022-03-18

Non-contact Infrared Thermometer (Models WL-301, WL-501, WL-601, WL-701)

Applicant Sichuan Youkede Medical Equipment Co.,Ltd

K-Number K210171

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BWK 2022-03-18

Needle Stimulator (Model: RJNS6-1)

Applicant Bozhou Rongjian Medical Appliance Co., Ltd.

K-Number K220153

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BZD 2022-03-18

F&P Evora Full Face Mask

Applicant Fisher & Paykel Healthcare, Ltd.

K-Number K212371

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MTD 2022-03-18

OPTRELL Mapping Catheter with TRUEref Technology

Applicant Biosense Webster, Inc.

K-Number K211438

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