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

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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QTY 2022-09-29

INNOVANCE VWF Ac

Applicant Siemens Healthcare Diagnostics Products GmbH

K-Number DEN200067

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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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KWT 2022-09-28

AGILON XO Shoulder System

Applicant Implantcast GmbH

K-Number K222482

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MED 2022-09-28

SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate

Applicant STERIS Corporation

K-Number K222615

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HIS 2022-09-28

TROJAN Fire & Ice lubricated male natural rubber latex condom

Applicant Church & Dwight Co., Inc.

K-Number K221906

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KNG 2022-09-28

Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)

Applicant Contec Medical Systems Co.,Ltd

K-Number K220245

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QAS 2022-09-28

BriefCase

Applicant Aidoc Medical , Ltd.

K-Number K222329

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KGN 2022-09-28

InnovaMatrix PD

Applicant Triad Life Sciences, Inc.

K-Number K211902

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