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

GEI 2019-10-08

Single-Use Non-Stick Bipolar forceps Bayonet, Single-Use Non-Stick Bipolar Irrigating forceps, Single Use Non-Stick Bipolar Suction forceps

Applicant Faulhaber Pinzetten Ohg

K-Number K182773

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DZE 2019-10-08

Advanced Intermezzo Implant System

Applicant Megagen Implant Co., Ltd.

K-Number K191127

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PEM 2019-10-08

Barrier Sleeves

Applicant Ivoclar Vivadent, AG

K-Number K191448

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HSX 2019-10-08

Bodycad Unicompartmental Knee System

Applicant Bodycad Laboratories, Inc.

K-Number K191150

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OLO 2019-10-08

Premia Spine XL Instruments

Applicant Premia Spine, Ltd.

K-Number K191854

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PME 2019-10-08

KATANA Cleaner, KATANA Cleaner (Trial)

Applicant Kuraray Noritake Dental, Inc.

K-Number K191133

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KRO 2019-10-08

Attune Revision LPS Inserts

Applicant Depuy(Ireland)

K-Number K191779

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OLO 2019-10-08

TSolution One Total Knee Application

Applicant THINK Surgical, Inc.

K-Number K191369

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PMN 2019-10-07

Cepheid Xpert Respiratory Control Panel

Applicant Microbiologics, Inc.

K-Number K190086

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QII 2019-10-07

Dexcom G6 Pro Continuous Glucose Monitoring System

Applicant Dexcom, Inc.

K-Number K191833

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FMI 2019-10-07

NIO-I

Applicant Waismed, Ltd.

K-Number K190538

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HEB 2019-10-07

Interlude Rolled Tampons in Plastic Applicator

Applicant Albaad Fem

K-Number K191431

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