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

JDR 2019-08-16

TriMAX Implant System

Applicant Crossroads Extemity Systems, LLC

K-Number K190722

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KGO 2019-08-16

Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove

Applicant Hartalega NGC Sdn. Bhd.

K-Number K183536

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JAA 2019-08-16

PowerDR

Applicant Radiology Information Systems, Inc.

K-Number K191504

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CFR 2019-08-16

Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions

Applicant Roche Diagnostics

K-Number K191899

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ODP 2019-08-16

Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic Interbody Fusion Device, Endoskeleton TO Interbody Fusion Device, Endoskeleton TT Interbody Fusion Device, Endoskeleton TC Interbody Fusion Device, Endoskeleton TCS Interbody Fusion Device, Endoskeleton TL Interbody Fusion Device

Applicant Titan Spine, Inc.

K-Number K192018

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FAD 2019-08-16

Tria Soft Ureteral Stent

Applicant Boston Scientific Corporation

K-Number K191609

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BWF 2019-08-16

Combined Aerobika OPEP and VersaPAP device

Applicant Trudell Medical International

K-Number K183108

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ELC 2019-08-16

Piezon Built-in Kit, Piezon Built-in Kit LED

Applicant E.M.S Electro Medical Systems S.A

K-Number K191079

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NLQ 2019-08-15

Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology

Applicant Sterilmed, Inc.

K-Number K190610

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KPE 2019-08-15

HCT Empty EVA Container Pack

Applicant Health Care Technologies

K-Number K190328

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PLB 2019-08-15

Biovitals Analytics Engine

Applicant Biofourmis Singapore Pte., Ltd.

K-Number K183282

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PJA 2019-08-15

HeartFlow FFRct Analysis

Applicant HeartFlow, Inc.

K-Number K190925

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