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

MQL 2020-10-23

Sequential Culture Media (Fertilization Medium [without HSA/rHA, with HSA, with rHA], Cleavage Medium [without HSA/rHA, with HSA, with rHA], Blastocyst Medium [without HSA/rHA, with HSA, with rHA])

Applicant Kitazato Corporation

K-Number K200249

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QGT 2020-10-23

Nerivio

Applicant Theranica Bio-Electronics, Ltd.

K-Number K201824

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EOQ 2020-10-22

Broncoflex Agile; Product Reference: 20030001 , Broncoflex Vortex; Product Reference: 10030001, Screeni; Product Reference: 30030001

Applicant Axess Vision Technology

K-Number K202180

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GEX 2020-10-22

AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories

Applicant Lumenis, Ltd.

K-Number K202428

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HWC 2020-10-22

GEO Bone Screw System

Applicant Gramercy Extremity Orthopedics, LLC

K-Number K202817

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EBI 2020-10-22

DIOnavi-Denture

Applicant Dio Corporation

K-Number K193623

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ERL 2020-10-22

UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece

Applicant KARL STORZ Endoscopy-America, Inc.

K-Number K200318

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IYN 2020-10-22

Voluson E10

Applicant GE Healthcare

K-Number K201768

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LLZ 2020-10-22

EzOrtho

Applicant Ewoosoft Co., Ltd.

K-Number K202948

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NKB 2020-10-21

Trivergent Spinal Fixation System

Applicant Benvenue Medical, Inc.

K-Number K201427

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LPH 2020-10-21

ACTIS Duofix Hip Prosthesis

Applicant DePuy Orthopaedics, Inc.

K-Number K202472

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NEU 2020-10-21

C4 Fiducial Marker

Applicant C4 Imaging, LLC

K-Number K192771

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