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

NKG 2018-12-12

ANAX OCT Spinal System

Applicant U&I Corporation

K-Number K183383

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QCX 2018-12-12

Retrograde Intubation Set

Applicant Cook Incorporated

K-Number DEN170055

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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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GEI 2018-12-11

Mygen V-1000 RF System

Applicant RF Medical Co., Ltd.

K-Number K180999

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MAX 2018-12-11

Life Spine Resolute Threaded Cage System

Applicant Life Spine, Inc.

K-Number K181625

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