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

DXH 2020-11-06

SimpleSENSE

Applicant Nanowear, Inc.

K-Number K201669

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HIS 2020-11-06

Durex Penck Standard, Durex Penck XL

Applicant Rb Health (Us), LLC

K-Number K200672

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KRD 2020-11-05

LOBO Vascular Occlusion System (model LOBO-5)

Applicant Okami Medical

K-Number K203025

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KYZ 2020-11-05

OtoSet- Ear Cleaning System

Applicant Safkan, Inc.

K-Number K201877

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NYI 2020-11-05

MammaPrint

Applicant Agendia, Inc.

K-Number K201902

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NKB 2020-11-05

Salvo® Spine System

Applicant Spine Wave, Inc.

K-Number K202476

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OWN 2020-11-05

SPY-PHI System with SPY-PHI Fluorescence Assessment Software

Applicant Novadaq Technologies Ulc. (Now A Part of Stryker)

K-Number K202244

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KWQ 2020-11-05

KASILOF Cervical Plate System

Applicant Kahtnu Surgical, Inc.

K-Number K203154

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PIF 2020-11-05

Gabriel 3 Way EnFit Valve

Applicant Syncro Medical Innovations, Inc.

K-Number K201741

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FMI 2020-11-05

Eclipse DermaFlex Cannula

Applicant Eclipse Medcorp, LLC

K-Number K200017

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EBG 2020-11-05

GR-17 Resin System

Applicant Pro3Dure Medical GmbH

K-Number K201827

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MBI 2020-11-04

Arthrex TightRope II

Applicant Arthrex, Inc.

K-Number K202581

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