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

LBI 2021-05-28

Infant Phototherapy Equipment

Applicant Bistos Co., Ltd.

K-Number K210289

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FQH 2021-05-28

Irrisept Antimicrobial Wound Lavage

Applicant Irrimax Corporation

K-Number K210536

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HWC 2021-05-28

Axis Charcot Fixation System

Applicant Extremity Medical, LLC

K-Number K211261

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OWI 2021-05-27

LigaPASS® Spinal System, CD Horizon Spinal System

Applicant Medtronic, Inc.

K-Number K211057

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KNS 2021-05-27

Aqua Medical RF Vapor System

Applicant Aqua Medical, Inc.

K-Number K211282

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NWJ 2021-05-27

GalaSTITCH Absorbable Monofilament Suture

Applicant Tepha, Inc.

K-Number K211307

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LLZ 2021-05-27

ZedView

Applicant Lexi Co., Ltd.

K-Number K200704

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NVM 2021-05-27

BIB Stent Placement Catheter

Applicant NuMED, Inc.

K-Number K211134

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KGO 2021-05-27

ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content Labeling Claim (50 micrograms or less) and Tested for use with Chemotherapy drugs

Applicant Careplus (M) Sdn Bhd

K-Number K202765

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QOI 2021-05-27

SafeBreak Vascular

Applicant Site Saver, Inc. D/B/A Lineus Medical

K-Number DEN190043

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GDW 2021-05-27

Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler and Reloads, Disposable Linear Cutter Stapler and Reloads, Disposable Endoscopic Linear Cutter Stapler and Reloads

Applicant Beijing Biosis Healing Biolog Ical Technology Co., Ltd.

K-Number K201639

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MAX 2021-05-26

Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA Interbody System, Endoskeleton TAS & TAS Hyp Interbody System, Endoskeleton TL Interbody System, Endoskeleton TL Hyp. Interbody System, Endoskeleton TO Interbody System, Endoskeleton TT Interbody System

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K211258

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