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

HWC 2020-01-08

Tyber Medical Trauma Screw

Applicant Tyber Medical, LLC

K-Number K192974

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NXC 2020-01-08

Clear Aligner

Applicant Royal Dental Lab

K-Number K192767

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OVE 2020-01-08

Genesys Spine 3DP Cervical Interbody System

Applicant Genesys Spine

K-Number K191489

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JWY 2020-01-08

Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint, Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/mL

Applicant Thermo Fisher Scientific

K-Number K193024

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OVD 2020-01-08

Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion Device

Applicant Titan Spine, Inc.

K-Number K191581

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GCJ 2020-01-08

EASYGRIP FLO-41 Precision MIS Delivery System

Applicant Baxter Healthcare Corportation

K-Number K193137

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DQY 2020-01-07

BioCardia 8F Morph DNA Deflectable Guide Catheter

Applicant Biocardia

K-Number K192774

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GEH 2020-01-07

ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO 2 footswitch; Flexible Cryoprobe; ERBECRYO 2 Cart, VIO-Cart, Wire basket; Connecting hoses, switching valves, adapter

Applicant Erbe Elektromedizin GmbH

K-Number K190651

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KWI 2020-01-07

Avenger Radial Head System

Applicant In2bones USA, LLC

K-Number K192754

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DRG 2020-01-07

VV330 Continuous ECG Platform, VivaLNK Adhesive Patch

Applicant VivaLNK, Inc.

K-Number K191870

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GEI 2020-01-07

CRF Radiofrequency Ablation System

Applicant Cambridge Interventional, LLC

K-Number K192715

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LZA 2020-01-07

Disposable Powder Free Nitrile Examination Glove, Pink/Black Color

Applicant Ever Growth (Vietnam) Co. , Ltd.

K-Number K190942

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