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

EGJ 2020-02-10

Dermadry

Applicant Dermadry Laboratories, Inc.

K-Number K192749

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NKG 2020-02-10

M.U.S.T. MINI Posterior Cervical Screws System

Applicant Medacta International S.A.

K-Number K200130

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NUC 2020-02-10

JO for Him H2O Gel Original Personal Lubricant

Applicant United Consortium

K-Number K192203

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DZE 2020-02-10

K3Pro Konus New Abutments and Implants

Applicant Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG

K-Number K190192

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GEI 2020-02-10

Sutter Swyng non-stick bipolar forceps, single-use

Applicant Sutter Medizintechnik GmbH

K-Number K193587

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MBI 2020-02-10

MectaFix CL Fixation Button with Continuous Loop

Applicant Medacta International S.A.

K-Number K193165

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CGA 2020-02-07

i-STAT CHEM8+ cartridge with the i-STAT 1 System

Applicant Abbott Point of Care, Inc.

K-Number K183678

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KLE 2020-02-07

DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill Package Type A, DIAETCH Intro Kit

Applicant DiaDent Group International

K-Number K192273

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JGS 2020-02-07

i-STAT CHEM8+ cartridge with the i-STAT 1 System

Applicant Abbott Point of Care, Inc.

K-Number K183688

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QJU 2020-02-07

Caption Guidance

Applicant Bay Labs, Inc.

K-Number DEN190040

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BTG 2020-02-07

Pulmonary Cytology Brush

Applicant Hobbs Medical, Inc.

K-Number K182927

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PAH 2020-02-07

Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack

Applicant Caldera Medical, Inc.

K-Number K191416

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