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

LZO 2020-04-25

PROFEMUR GLADIATOR Thin HA Classic Hip Stem with Collar

Applicant Microport Orthopedics, Inc.

K-Number K200007

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HCG 2020-04-25

i-ED COIL

Applicant Kaneka Pharma America, LLC

K-Number K192068

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LZA 2020-04-25

Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)

Applicant Hartalega NGC Sdn. Bhd.

K-Number K200581

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PZM 2020-04-24

PGDx elio tissue complete

Applicant Personal Genome Diagnostics

K-Number K192063

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OVE 2020-04-24

SPIRA-C Integrated Fixation System

Applicant Camber Spine Technologies

K-Number K193153

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JWH 2020-04-24

Smith&Nephew VISIONAIRE Patient Matched Cutting Blocks

Applicant Smith & Nephew, Inc.

K-Number K200826

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KPO 2020-04-24

Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K-Number K192017

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OWB 2020-04-24

O-arm O2 Imaging System

Applicant Medtronic, Inc.

K-Number K200074

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MAX 2020-04-24

SeaSpine Reef TH System

Applicant SeaSpine Orthopedics Corporation

K-Number K193636

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KDL 2020-04-24

Custodiol HTK Solution

Applicant Dr. Franz Kohler Chemie GmbH

K-Number K192408

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GEX 2020-04-24

MT One

Applicant M&T S.R.L.

K-Number K192856

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NKB 2020-04-24

EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine System

Applicant Medos International Sàrl

K-Number K200245

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