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

FFX 2024-05-06

Solar Compact (G4-1)

Applicant Laborie Medical Technologies, Corp.

K-Number K240007

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JAK 2024-05-03

CT 5300

Applicant Philips Healthcare (Suzhou) Co., Ltd.

K-Number K232491

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LRK 2024-05-03

EMA 3D

Applicant Ema Sleep Incorporated

K-Number K232735

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MBI 2024-05-03

Megaloop Button System

Applicant Suzhou Endophix Co., Ltd.

K-Number K232941

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OVD 2024-05-03

ProAM ALIF System

Applicant Pro Surgical, Inc.

K-Number K240126

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PGI 2024-05-03

Alinity m HSV 1 & 2 / VZV

Applicant Abbott Molecular, Inc.

K-Number K233349

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EZD 2024-05-03

Sleeved IC 2 Family; Sleeved IC 2 SWT (Name not Finalized); Sleeved IC 2 Plus (Name not Finalized); Sleeved IC 2 Pocket (Name not Finalized); Sleeved IC 2 Plus Pocket (Name not Finalized)

Applicant Hollister Incorporated

K-Number K233524

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GEX 2024-05-03

VaporMAX LDD; MOJo LDD; MegaJOULE LDD

Applicant Innovaquartz, LLC

K-Number K233157

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LHI 2024-05-03

Vial2Bag Advanced® 20mm Admixture Device

Applicant West Pharmaceutical Services, Inc.

K-Number K240940

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MIX 2024-05-03

Silk Voice (SMI-04)

Applicant Sofregen Medical

K-Number K240919

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GEJ 2024-05-03

Cypris eXact Suture Placement Device

Applicant Cypris Medical

K-Number K240185

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IYO 2024-05-03

B-Ultrasound Diagnostic System

Applicant Contec Medical Systems Co.,Ltd

K-Number K232895

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