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

MBH 2021-10-01

Porous Patella and Porous Tibia Baseplate

Applicant Smith & Nephew, Inc.

K-Number K211221

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DZE 2021-09-30

Implanova

Applicant Dental Evolutions, Inc.

K-Number K210523

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FPA 2021-09-30

Intravascular Administration Sets

Applicant Baxter Healthcare Corporation

K-Number K203609

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MWI 2021-09-30

Philips MR Patient Care Portal

Applicant Invivo Corporation

K-Number K212227

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HIS 2021-09-30

Playboy 3 Contour Condom

Applicant Thai Nippon Rubber Industry Public Company Limited.

K-Number K211450

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KWQ 2021-09-30

EMERGE Anterior Cervical Plate System

Applicant Evolution Spine

K-Number K212405

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IYE 2021-09-30

Accuray Precision Treatment Planning System

Applicant Accuray Incorporated

K-Number K212794

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PMY 2021-09-30

Acuitas AMR Gene Panel

Applicant Opgen, Inc.

K-Number K191288

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DWF 2021-09-30

AngioVac F18 85

Applicant AngioDynamics, Inc.

K-Number K212386

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JAK 2021-09-30

NAEOTOM Alpha, Scan&GO

Applicant Siemens Medical Solutions USA, Inc.

K-Number K211591

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OQY 2021-09-30

Jada System

Applicant Alydia Health

K-Number K212757

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HTY 2021-09-30

Small Bone Nailing System

Applicant Skeletal Dynamics, Inc.

K-Number K211439

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