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

KCT 2019-07-05

Aesculap® SterilContainer(TM) S2 System

Applicant Aesculap, Inc.

K-Number K182414

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BZD 2019-07-05

Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented Mask

Applicant Sleepnet Corporation

K-Number K190254

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NGX 2019-07-05

BTL 799-2L

Applicant BTL Industries, Inc.

K-Number K190456

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DWF 2019-07-05

AngioVac C20, AngioVac C180

Applicant AngioDynamics, Inc.

K-Number K190594

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JXG 2019-07-05

Miethke Shunt System GAV 2.0 and SA 2.0 Valves

Applicant Aesculap, Inc.

K-Number K190174

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HSB 2019-07-05

Zimmer Guide Wire Devices

Applicant Zimmer, Inc.

K-Number K191238

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HWC 2019-07-05

OrthoPediatrics Cannulated Screw System

Applicant OrthoPediatrics Corp.

K-Number K190324

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JAK 2019-07-05

Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE

Applicant Canon Medical Systems Corporation

K-Number K182901

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LZC 2019-07-04

Blue Non-Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Low Dermatitis and Fentanyl Permeation Resistance Claim

Applicant Central Medicare Sdn Bhd

K-Number K183149

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FYA 2019-07-04

Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medline Level 3 Surgical Gown (Eclipse Fabric Reinforced), Medline Level 3 Surgical Gown (Sirus Non-Reinforced), Medline Level 3 Surgical Gown (Sirus Fabric Reinforced), Medline Level 3 Surgical Gown (Aurora Non Reinforced & Aurora Fabric Reinforced)

Applicant Medline Industries, Inc.

K-Number K190950

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MBI 2019-07-03

Infinity Fixation System

Applicant Conmed Corporation

K-Number K191204

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IZL 2019-07-03

CMDR 2CW (Multiple models)

Applicant Minxray, Inc.

K-Number K191451

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