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

JWY 2023-06-30

Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC, or Breakpoint Susceptibility System with Imipenem-relebactam in the dilution, range of 0.03/4-128-4ug/ml (Haemophilus influenzae)

Applicant Thermo Fisher Scientific

K-Number K230935

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HGX 2023-06-30

Compact Wearable Pump

Applicant Lansinoh Laboratories

K-Number K230469

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HSB 2023-06-30

SGM Femoral Nail System

Applicant Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.

K-Number K230456

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QEB 2023-06-30

AirTom

Applicant Bilab

K-Number K222466

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JKA 2023-06-30

Unistik® ShieldLock, Unistik VacuFlip

Applicant Owen Mumford, Ltd.

K-Number K223854

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OWQ 2023-06-30

ViewFlex Eco Reprocessed ICE Catheter

Applicant ABBOTT MEDICAL

K-Number K231588

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LLZ 2023-06-30

Pixyl.Neuro

Applicant Pixyl SA

K-Number K213253

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QPS 2023-06-30

MeMed BV

Applicant MeMed Diagnostics, Ltd.

K-Number K230944

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GEI 2023-06-30

AblatePal Radiofrequency Ablation System

Applicant Compal Electronics, Inc.

K-Number K223135

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LOX 2023-06-29

Coronary Dilatation Balloon Catheter (VesPenetrator®), Coronary Dilatation Balloon Catheter (VesTraveler®), Coronary Dilatation Balloon Catheter (VexPander®)

Applicant Dongguan TT Medical, Inc.

K-Number K230374

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HWC 2023-06-29

OsteoCentric ACL Fixation System

Applicant OsteoCentric Technologies

K-Number K230595

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EZL 2023-06-29

Flume Catheter

Applicant Flume Catheter Company, Ltd.

K-Number K231101

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