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

KNT 2022-06-07

Lap-Band System Calibration Tube

Applicant Reshape Lifesciences

K-Number K220455

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ITX 2022-06-07

Natural Rubber Latex Ultrasound Transducer Probe Covers

Applicant Global Protection Corp.

K-Number K213087

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PQA 2022-06-07

Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System

Applicant Cepheid

K-Number K221160

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MSX 2022-06-07

Infinity Gateway Suite

Applicant Draeger Medical Systems, Inc.

K-Number K203579

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OWB 2022-06-07

D²RS and D²RS 9090

Applicant Stephanix

K-Number K221335

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HTN 2022-06-06

Arthrex Knotless AC Repair Devices

Applicant Arthrex, Inc.

K-Number K220947

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ODP 2022-06-06

Keos Anterior Cervical Interbody Fusion Device System

Applicant Keos

K-Number K212450

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IYN 2022-06-06

Voluson Expert 22, Voluson Expert 20, Voluson Expert 18

Applicant GE Medical Systems Ultrasound and Primary Care Diagnostics

K-Number K220358

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NHA 2022-06-06

PrimeLOC Attachment System

Applicant Innovative Product Brands, Inc.

K-Number K220612

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FDI 2022-06-06

Disposable Polypectomy Snare

Applicant Beijing Zksk Technology Co., Ltd.

K-Number K213222

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PZR 2022-06-06

Drug Relief v1

Applicant Dyansys, Inc.

K-Number K221231

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KTT 2022-06-06

Smart Correction System Rings and Compatible HA-Coated Half Pins

Applicant Wishbone Medical, Inc.

K-Number K221366

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