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

LLZ 2019-03-08

RADMAX Digital Imaging Software

Applicant DRGEM Corporation

K-Number K182537

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LPH 2019-03-08

Provident II Hip Stem

Applicant Stelkast, Inc.

K-Number K190276

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LRK 2019-03-08

ZAPnea Oral Appliance

Applicant B. Fareid, Dds, PC

K-Number K173064

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QCI 2019-03-08

Brainsway Deep TMS System

Applicant Brainsway , Ltd.

K-Number K183303

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IYN 2019-03-08

DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K-Number K190206

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IYO 2019-03-08

EchoSure Diagnostic Ultrasound System

Applicant Sonavex, Inc.

K-Number K190039

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JAK 2019-03-08

NewTom 5G XL

Applicant Cefla S.C.

K-Number K183448

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FRO 2019-03-08

Medline Burn and Wound Dressing (OTC)

Applicant Medline Industries, Inc.

K-Number K190224

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HRX 2019-03-08

CORUS Spinal System

Applicant Providence Medical Technology, Inc.

K-Number K190201

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MAX 2019-03-08

Kuros TLIF Cage

Applicant Kuros Biosciences B.V

K-Number K183092

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PGY 2019-03-08

RadiForce MX216

Applicant Eizo Corporation

K-Number K190153

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EOQ 2019-03-08

CoreDx Pulmonary Mini-Forceps

Applicant Boston Scientific Corporation

K-Number K183085

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