Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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

JXI 2022-07-15

Nerve Tape

Applicant Biocircuit Technologies, Incorporated

K-Number K210665

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CAF 2022-07-15

Hailie Sensor NF0106

Applicant Adherium (Nz), Ltd.

K-Number K220622

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GEI 2022-07-15

Renuvion APR Handpiece

Applicant Apyx Medical Corporation(Formerly Bovie Medical Corporation)

K-Number K220970

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QRK 2022-07-15

Facet 28G Universal Lancet

Applicant Facet Technologies, LLC

K-Number K221433

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EFB 2022-07-15

OK Handpiece

Applicant Jaintek Co.,Ltd

K-Number K221814

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BTY 2022-07-15

Model 9100 PFT/DICO

Applicant Vitalograph Ireland, Ltd.

K-Number K221030

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DRG 2022-07-15

ers2 - ergoline Rehabilitation System

Applicant Ergoline GmbH

K-Number K212883

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EIH 2022-07-14

KDF Zirconia Disc

Applicant Denken-Highdental Co., Ltd.

K-Number K221429

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GEI 2022-07-14

AGNES

Applicant Agnes Medical Co., Ltd.

K-Number K203013

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QPS 2022-07-14

LIAISON MeMed BV, LIAISON MeMed BV Control Set

Applicant DiaSorin, Inc.

K-Number K213936

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HIS 2022-07-14

TROJAN(TM) Her Pleasure Warming male natural rubber latex condom with warming lubricant

Applicant Church & Dwight Co., Inc.

K-Number K221431

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JKA 2022-07-14

20G Open-System Ally Device Kit (AV100000), 22G Open-System Ally Device Kit (AV110000)

Applicant Avia Vascular

K-Number K220258

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