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

ODC 2022-03-29

Guidewire Locking Device

Applicant Micro-Tech (Nanjing) Co., Ltd.

K-Number K220247

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NBW 2022-03-29

GAL-1A Plus Blood Glucose Monitoring System

Applicant Apex BioTechnology Corp.

K-Number K213887

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QSL 2022-03-29

BrainTemp Neonate System (BTNeo System)

Applicant Brain Temp, Inc.

K-Number DEN200042

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MQB 2022-03-29

Focus HD 43 Detector

Applicant Iray Technology Taicang , Ltd.

K-Number K213529

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OLO 2022-03-29

REAL INTELLIGENCE CORI

Applicant Blue Belt Technologies, Inc.

K-Number K220255

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OXZ 2022-03-29

Dukal Corporation Level 1 Pediatric Face Mask

Applicant Dukal Corporation

K-Number K210321

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ODP 2022-03-29

Reliance Cervical IBF System

Applicant Reliance Medical Systems, LLC

K-Number K202266

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MAI 2022-03-28

OSSIOfiber Suture Anchor

Applicant OSSIO , Ltd.

K-Number K213415

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EIH 2022-03-28

CERABIEN MiLai

Applicant Kuraray Noritake Dental, Inc.

K-Number K213147

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DZE 2022-03-28

T3 Pro Implants

Applicant Biomet 3i, LLC

K-Number K213672

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JAK 2022-03-28

Syngo.CT Dual Energy

Applicant Siemens Medical Solutions USA, Inc.

K-Number K212889

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LZA 2022-03-28

Disposable nitrile rubber protective gloves (Tested for Use with Chemotherapy Drugs)

Applicant Taishan Weibang Medical Equipment Co., Ltd.

K-Number K213662

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