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

JKR 2018-12-21

ADVIA Centaur Calcitonin (CALCT) assay

Applicant Axis-Shield Diagnostics Limited

K-Number K182012

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HRS 2018-12-21

TruMatch Graft Cage - Long Bone

Applicant Synthes (Usa), LLC

K-Number K180821

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DQA 2018-12-21

vital signs monitor

Applicant Edan Instruments, Inc.

K-Number K180380

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NHA 2018-12-21

DIO CAD/CAM Abutment

Applicant Dio Corporation

K-Number K181037

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KWS 2018-12-21

Arthrex Fracture Adapter Hemi Shoulder Prosthesis

Applicant Arthrex, Inc.

K-Number K181555

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OOE 2018-12-21

LENSAR Laser System - fs 3D (LLS-fs 3D)

Applicant Lensar, Inc.

K-Number K182795

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MHX 2018-12-21

North-vision Multi-parameter Patient Monitor

Applicant North-Vision Tech., Inc.

K-Number K173036

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QDI 2018-12-21

MLL (KMT2A) Breakapart FISH Probe Kit; AML1 (RUNX1) Breakapart FISH Probe Kit, P53 (TP53) Deletion FISH Probe Kit; EVI1 (MECOM) Breakapart FISH Probe Kit, Del(20q) Deletion FISH Probe Kit; AML1/ETO (RUNX1/RUNXIT1)) Translocation, Dual Fusi, CBFB (CBFB) /MYH11 Translocation, Dual Fusion FISH Probe Kit,Del(5q)Deletion FISH Probe Kit; Del(7q)Deletion FISH Probe Kit

Applicant Cytocell, Ltd.

K-Number DEN170070

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FBK 2018-12-21

Clear-Jet Injection Catheter

Applicant Finemedix Co., Ltd.

K-Number K181690

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HRX 2018-12-21

Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter)

Applicant Stryker Corporation

K-Number K181752

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LLZ 2018-12-21

4D View

Applicant GE Medical Systems Ultrasound and Primary Care Diagnostics

K-Number K182750

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JOW 2018-12-21

Pulse Rx 2.0, Pulse Pro Rx 2.0

Applicant NormaTec Industries, LP

K-Number K183328

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