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

NKB 2017-12-05

Arisstos Spinal System

Applicant Ingenium Spine

K-Number K173126

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GEI 2017-12-05

Vivaer ARC Stylus

Applicant Aerin Medical, Inc.

K-Number K172529

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GCJ 2017-12-05

SYSTEMS INTEGRATION ENDOALPHA MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-4 Software Version 1

Applicant Olympus Medical Systems Corp.

K-Number K172618

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IYN 2017-12-05

P20 Series Digital Color Doppler Ultrasound System

Applicant Sonoscape Medical Corp.

K-Number K172993

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EBF 2017-12-05

Renamel Microfill

Applicant Cosmedent, Inc.

K-Number K172707

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OCC 2017-12-04

Panther Fusion AdV/hMPV/RV Assay

Applicant Hologic, Inc.

K-Number K172629

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PSQ 2017-12-04

PhotoFix Decellularized Bovine Pericardium

Applicant Cryolife, Inc.

K-Number K172085

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MAX 2017-12-04

Velofix TLIF Cage

Applicant U&I Corporation

K-Number K172419

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LRX 2017-12-04

Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc

Applicant Alcon Laboratories, Inc.

K-Number K173538

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PDJ 2017-12-04

ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay

Applicant Siemens Healthcare Diagnostics, Inc.

K-Number K171771

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MAX 2017-12-04

SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica; SeaSpine Spacer System -Hollywood, Hollywood VI, Ventura, Pacifica; SeaSpine Vu e·POD System

Applicant SeaSpine Orthopedics Corporation

K-Number K173260

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QEW 2017-12-04

ClotTriever Thrombectomy System, ClotTriever Catheter, ClotTriever Sheath

Applicant Inari Medical

K-Number K173470

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