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

OZZ 2018-07-15

Solana Bordetella Complete Assay

Applicant Quidel Corporation

K-Number K181029

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MQB 2018-07-13

Aquarius 8600 Digital Radiography Sensor

Applicant Biokinemetrics, Inc.

K-Number K181565

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JXG 2018-07-13

IRRAflow CNS System

Applicant Irras, Inc.

K-Number K171880

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FYA 2018-07-13

Surgical gown (AE1001, AE2001, AE3001); Surgical Gown (AG1001, AG2001, AG3001)

Applicant Gmax Industries, Inc.

K-Number K172987

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PDJ 2018-07-13

Dimension Hemoglobin A1c Assay

Applicant Siemens Healthcare Diagnostics, Inc.

K-Number K173909

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PLR 2018-07-13

Normandy VBR System

Applicant Zavation Medical Products, LLC

K-Number K180673

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BZG 2018-07-13

Pulmonx Chartis Tablet Console

Applicant Pulmonx Corporation

K-Number K180011

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EZL 2018-07-13

Yikang Latex Foley Catheter

Applicant Jiangxi Yikang Medical Instrument Group Co., Ltd.

K-Number K173340

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KWQ 2018-07-13

Kestrel Buttress Plate System

Applicant Innovasis, Inc.

K-Number K181063

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GEI 2018-07-13

PINXEL-RF system

Applicant Rohrer Aesthetics, LLC

K-Number K180654

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NKB 2018-07-13

Viking Lumbar Polyaxial Screw System

Applicant Presidio Surgical

K-Number K180655

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DBM 2018-07-13

EliA M2 Immunoassay

Applicant Phadia AB

K-Number K181556

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