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

NBW 2017-09-27

FreeStyle Precision Neo Blood Glucose Test Strips

Applicant Abbott Diabetes Care, Inc.

K-Number K171941

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NKB 2017-09-26

ROMEO® 2 Posterior Osteosynthesis System

Applicant Spineart

K-Number K172101

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OCC 2017-09-26

Panther Fusion Flu A/B/RSV Assay, Panther Fusion Universal Fluids Kit, Panther Fusion Assay Fluids I-S Kit, Panther Fusion Specimen Lysis Tubes

Applicant Hologic, Inc.

K-Number K171963

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PIF 2017-09-26

Vesco Medical Nasoenteric Feeding Tubes

Applicant Vesco Medical, LLC

K-Number K170162

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LZA 2017-09-26

POWDER FREE NITRILE EXAMINATION GLOVES, BLUE (COLORED)

Applicant Careglove Global Sdn. Bhd.

K-Number K172015

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MAX 2017-09-26

CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal System

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K171107

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LLZ 2017-09-26

Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature Correction, Elements TRAM

Applicant Brainlab AG

K-Number K170816

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PKT 2017-09-26

SculpSure

Applicant Cynosure, Inc.

K-Number K171992

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MQB 2017-09-26

CareView 1800Cw X-ray Flat Panel Detectors

Applicant Careray Digital Medical System Co., Ltd.

K-Number K172581

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PGX 2017-09-25

Xpert Xpress Strep A

Applicant Cepheid

K-Number K172126

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DPS 2017-09-25

Electrocardiograph

Applicant Edan Instruments, Inc.

K-Number K171943

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MQC 2017-09-25

Urbanek Device

Applicant Tmj Services, LLC

K-Number K170985

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