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

HWC 2021-07-23

IntraLock System

Applicant Fusion Orthopedics, LLC

K-Number K210159

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OVE 2021-07-23

Blustone Synergy Diamond SA Cervical System

Applicant Blustone Synergy, LLC

K-Number K210382

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LZA 2021-07-23

Nitrile Patient Examination Gloves

Applicant Huayuan Medical Technology(Shangqiu) Co., Ltd.

K-Number K211012

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JWH 2021-07-23

Klassic Knee System

Applicant Total Joint Orthopedics, Inc.

K-Number K211602

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DQA 2021-07-23

VS Newborn Heart Rate Monitor

Applicant Surepulse Medical Limited

K-Number K201887

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JWY 2021-07-23

Sensititre 20-24 hour Haemophilus influenzae /Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dtest (containing erythromycin at 1 ug/mL and clindamycin at 0.5 ug/mL)

Applicant Thermo Fisher Scientific

K-Number K202612

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FXX 2021-07-23

Altor Safety 3-Ply Surgical Mask (Model:62222)

Applicant Altor Safety, LLC

K-Number K211249

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EOB 2021-07-23

Peregrine Endoscopy System

Applicant 3nt Medical , Ltd.

K-Number K202727

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FLL 2021-07-23

Infrared Forehead Thermometer, Model BSX976

Applicant Shenzhen Bsx Technology Electronics Co., Ltd.

K-Number K202296

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DYB 2021-07-23

CardioCurve Steerable Sheath

Applicant Talon Surgical

K-Number K210185

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KPO 2021-07-23

HMB32 Dialysis Solution

Applicant Haemopharm Biofluids S.R.L.

K-Number K212052

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NHA 2021-07-23

IS Multi Unit Abutment System

Applicant Neobiotech Co., Ltd.

K-Number K210903

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