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

MAI 2019-08-22

HEALIX ADVANCE SP BIOCOMPOSITE Anchor

Applicant Medos International SARL

K-Number K191242

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JWY 2019-08-22

ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)

Applicant Biomerieux S.A.

K-Number K191953

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EKX 2019-08-22

Osstell Beacon

Applicant Osstell AB

K-Number K181888

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HSN 2019-08-22

INFINITY Total Ankle System, INBONE Total Ankle System

Applicant Wrightmedicaltechnologyinc

K-Number K191393

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PBF 2019-08-21

VSP Orthopedics System

Applicant 3D Systems, Inc.

K-Number K190044

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NVE 2019-08-21

RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector

Applicant STERIS Corporation

K-Number K190081

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MUH 2019-08-21

ScanX Touch/ScanX Duo Touch

Applicant Air Techniques, Inc.

K-Number K191623

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JPA 2019-08-21

QNext and DG-PT

Applicant Diagnostic Grifols, S.A.

K-Number K183390

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BSP 2019-08-21

Arrow Epidural Needle KZ-05500-007(Luer); KZ-05500-009 (NRFit)

Applicant Teleflex Medical

K-Number K190026

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EOQ 2019-08-21

GlideScope BFlex 5.8 Single-Use Bronchoscope

Applicant Verathon Medical (Canada) Ulc

K-Number K191948

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PZX 2019-08-21

AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA Exclusion System with preloaded V-Clip

Applicant AtriCure, Inc.

K-Number K191413

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PHX 2019-08-20

Exactech Equinoxe Humeral Augmented Trays

Applicant Exactech, Inc.

K-Number K191561

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