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

MNU 2022-01-21

OSSIOfiber® Staple

Applicant OSSIO , Ltd.

K-Number K212594

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NKB 2022-01-21

PERLA® TL Posterior Osteosynthesis System

Applicant Spineart

K-Number K213470

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FLL 2022-01-21

Infrared Thermometer

Applicant Beijing Choice Electronic Technology Co., Ltd.

K-Number K211752

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JWH 2022-01-21

b-ONE MOBIO Total Knee System

Applicant B-One Ortho, Corp.

K-Number K213673

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LZA 2022-01-21

Nitrile Examination Gloves

Applicant Jiangsu Huayuan Medical Technology Co., Ltd.

K-Number K213044

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JOJ 2022-01-21

VERIFY STEAM Integrating Indicator, VERIFY STEAM Integrating Indicator 5CM

Applicant Steris Corparation

K-Number K213412

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GXD 2022-01-21

Abbott Medical Grounding Pad, model RF-DGP-IS

Applicant ABBOTT MEDICAL

K-Number K203293

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JOJ 2022-01-20

Gas-Chex Indicator

Applicant Propper Manufacturing Co., Inc.

K-Number K212592

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PIF 2022-01-20

Entuit PEG, Entuit PEGJ

Applicant Wilson-Cook Medical, Inc.

K-Number K213356

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EMA 2022-01-20

Parkell Self-Adhesive Cement

Applicant Parkell, Inc.

K-Number K210259

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JAK 2022-01-20

syngo.CT Extended Functionality

Applicant Siemens Medical Solutions USA, Inc.

K-Number K214019

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HGX 2022-01-20

Electric breast pump

Applicant Dongguan Rongfeng Medical Co., Ltd.

K-Number K212884

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