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

JOW 2020-09-19

B&J DVT Calf/Thigh Garments, Models 801/830 Series

Applicant B&J Manufacturing , Ltd.

K-Number K201532

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OUR 2020-09-18

Life Spine SIMPACT Sacroiliac Joint Fixation System

Applicant Life Spine, Inc.

K-Number K201538

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LZO 2020-09-18

SMS Cementless Stem

Applicant Medacta International S.A.

K-Number K201673

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KOC 2020-09-18

CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin Line

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K-Number K201207

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GEI 2020-09-18

Electrosurgical Generator and Accessories

Applicant Medrange

K-Number K201224

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MBI 2020-09-18

OrthoButton FL

Applicant Riverpoint Medical

K-Number K202399

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LLZ 2020-09-18

SentEP

Applicant Sentiar, Inc.

K-Number K192890

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KNW 2020-09-18

Ran-Flex-B Bone Marrow Aspiration Needle

Applicant Ranfac Corporation

K-Number K202287

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FXX 2020-09-18

Disposable Surgical Mask

Applicant Unisources Group, LLC

K-Number K202463

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JOW 2020-09-18

B&J DVT Foot Garments, Models 820 Series

Applicant B&J Manufacturing , Ltd.

K-Number K201547

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QJU 2020-09-18

Caption Guidance

Applicant Caption Health

K-Number K201992

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MHX 2020-09-18

Tempus Pro Patient Monitor

Applicant Remote Diagnostic Technologies Limited

K-Number K201746

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