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

MUH 2022-06-22

HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2)

Applicant Shanghai Handy Medical Equipment Co., Ltd.

K-Number K221008

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EBI 2022-06-22

Glidewell 3DP Denture Base Resin

Applicant Prismatik Dentalcraft, Inc.

K-Number K213765

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EWO 2022-06-22

Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE

Applicant Path Medical GmbH

K-Number K213345

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DQK 2022-06-22

HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable, HemoSphere Pressure Cable, HemoSphere ClearSight Module, HemoSphere Technology Module, HemoSphere ForeSight Oximeter Cable, Acumen Hypotension Prediction Index Feature, Acumen Assisted Fluid Management Feature, Viewfinder Remote

Applicant Edwards Lifesciences, LLC

K-Number K213682

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JWH 2022-06-22

Klassic Knee System

Applicant Total Joint Orthopedics, Inc.

K-Number K211877

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LYY 2022-06-22

TC Gloves

Applicant Thanh Cong Pharmaceutical and Trading Company Limited

K-Number K221185

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MMK 2022-06-22

Qlicksmart BladeFlask UNIVERSAL

Applicant Qlicksmart Pty , Ltd.

K-Number K213274

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ESW 2022-06-22

Esophageal TTS Stent

Applicant Taewoong Medical Co., Ltd.

K-Number K221482

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FTL 2022-06-22

Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Monofilament Mesh

Applicant Sofradim Production

K-Number K220586

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GCJ 2022-06-21

CORE-Trocar

Applicant Incore Co., Ltd.

K-Number K211148

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NUC 2022-06-21

Revaree Plus Vaginal Suppositories

Applicant Farma-Derma S.R.L.

K-Number K213220

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GEX 2022-06-21

Lumenis Y&R Laser System

Applicant Lumenis, Inc.

K-Number K211979

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