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

PML 2022-08-26

BonOs® Inject Bone Cement; NEO Pedicle Screw System

Applicant Neo Medical SA

K-Number K222256

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FGB 2022-08-26

Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Model: US31D-12-US)

Applicant Shanghai AnQing Medical Instrument Co., Ltd.

K-Number K220159

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GZJ 2022-08-26

StimOnTM Pain Relief System (GM2439)

Applicant Gimer Medical Co., Ltd.

K-Number K213802

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JWH 2022-08-26

LOSPA TKR System Instrumentation, EXULT TKR System Instrumentation

Applicant Corentec Co., Ltd.

K-Number K222278

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DXN 2022-08-26

Upper Arm Blood Pressure Monitor

Applicant Shenzhen Yolanda Technology Co., Ltd.

K-Number K221212

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PRI 2022-08-26

Dimension EXL LOCI BRAHMS Procalcitonin (PCT)

Applicant Siemens Healthcare Diagnostics, Inc.

K-Number K220262

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QAS 2022-08-26

BriefCase

Applicant Aidoc Medical , Ltd.

K-Number K222277

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ODP 2022-08-26

HAcancellous PEEK-C Porous HA PEEK Cervical IBF System

Applicant Innovasis, Inc.

K-Number K220875

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OBP 2022-08-26

BrainsWay Deep TMS System

Applicant Brainsway , Ltd.

K-Number K220819

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GXN 2022-08-26

MedCAD AccuShape Titanium Patient-Specific Cranial Implant

Applicant Medcad

K-Number K220357

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MAI 2022-08-26

Arthrex Self Punching SwiveLock Suture Anchors

Applicant Arthrex, Inc.

K-Number K222263

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OXC 2022-08-26

NEOVEIL Staple Line Reinforcement

Applicant Gunze Limited

K-Number K221487

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