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

NUH 2017-04-29

Digital TENS Unit

Applicant Shenzhen Eapply Technology Co., Ltd.

K-Number K170145

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LLZ 2017-04-28

syngo.CT View&GO

Applicant Siemens Medical Solutions USA, Inc.

K-Number K170952

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FRG 2017-04-28

Self Sealing Sterilization Pouches

Applicant Tianchang Jiarui Packaging Material Co., Ltd.

K-Number K162258

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IYE 2017-04-28

Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded)

Applicant Radiomed Corporation

K-Number K161724

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JGJ 2017-04-28

Randox RX Daytona Plus Magnesium (MG)

Applicant Randox Laboratories, Ltd.

K-Number K162200

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POP 2017-04-28

BrainPulse 1100

Applicant Jan Medical, Inc.

K-Number K170926

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FRC 2017-04-28

VERIFY ASSERT STEAM Process Challenge Device for Gravity Cycles

Applicant STERIS Corporation

K-Number K170070

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DQO 2017-04-28

Soft-Vu, Mariner, Accu-Vu and AngioOptic Catheters

Applicant AngioDynamics, Inc.

K-Number K161596

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FEB 2017-04-28

Scope-Assist Flushing Sink

Applicant Custom Ultrasonics, Inc.

K-Number K162120

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GXY 2017-04-28

WAVi Headset and WAVi eSoc Single Use Electrode Contacts

Applicant Wavi Co.

K-Number K162460

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OWP 2017-04-28

VERIFY ASSERT STEAM Process Challenge Device

Applicant STERIS Corporation

K-Number K162945

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DRE 2017-04-28

van Andel Dilatation Catheter

Applicant Cook Incorporated

K-Number K170616

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