Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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

FYA 2022-09-29

Surgical Gown (Sterile); Surgical Gown (Non-sterile)

Applicant Allmed Medical (Hubei) Protective Products Co., Ltd.

K-Number K221637

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MQB 2022-09-29

Digital Radiography CXDI-Elite, Digital Radiography E1

Applicant Canon, Inc.

K-Number K222687

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IZL 2022-09-29

GM85

Applicant Samsung Electronics Co., Ltd.

K-Number K222353

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SBF 2022-09-29

SpineAR SNAP

Applicant Surgical Theater, Inc.

K-Number K213034

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JDO 2022-09-29

Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, and cannulated screws

Applicant Smith & Nephew, Inc.

K-Number K213126

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OLO 2022-09-29

Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth(TM) Edition

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K222383

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JXG 2022-09-29

ReFlow System Mini

Applicant Anuncia Medical, Inc.

K-Number K221918

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OUR 2022-09-29

iFuse TORQ® Implant System

Applicant SI-BONE, Inc.

K-Number K222605

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KCT 2022-09-29

S.I.N. Instrument Kits

Applicant S.I.N. - Sistema DE Implante Nacional S.A.

K-Number K222005

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FGE 2022-09-28

EndoGI S-Path Biliary Stent System

Applicant Endo GI Medical

K-Number K222627

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KCT 2022-09-28

SteriCUBE® Multiple Tray Sterilization Systems

Applicant Stericube, LLC

K-Number K222328

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DRA 2022-09-28

MitraClip G4 Steerable Guide Catheter

Applicant ABBOTT MEDICAL

K-Number K221397

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