Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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

DZE 2018-12-13

PYRAMIDION Dental Implants and Prostheses

Applicant Dentack Implants, Ltd.

K-Number K180859

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DQY 2018-12-13

Selectra Catheters, Selectra Accessory Kit

Applicant Biotronik, Inc.

K-Number K183265

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NHA 2018-12-12

On1 Universal Abutment

Applicant Nobel Biocare AB

K-Number K181869

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NKG 2018-12-12

ANAX™ OCT Spinal System

Applicant U&I Corporation

K-Number K183383

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NKB 2018-12-12

LEUCADIA AUTOLOK™ Pedicle Screw System

Applicant Clearview Orthopedic Development, LLC

K-Number K182339

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GEI 2018-12-12

Medline Cautery Electrode (SILICONE)

Applicant Medline Industries, Inc.

K-Number K182812

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DQK 2018-12-12

EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2

Applicant Abbott

K-Number K183128

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GEX 2018-12-12

enlighten III Laser System

Applicant Cutera, Inc.

K-Number K182997

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KWQ 2018-12-12

PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate System, CAYMAN Thoracolumbar and Buttress Plate Systems

Applicant K2m, Inc.

K-Number K182473

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NKB 2018-12-12

Salvo™ Spine System

Applicant Spine Wave, Inc.

K-Number K182954

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EBG 2018-12-12

Harvest Dental Polymer Blocks

Applicant Harvest Dental Products, LLC

K-Number K180578

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NAY 2018-12-11

Intuitive Surgical Vessel Sealer Extend

Applicant Intuitive Surgical, Inc.

K-Number K183107

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