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

OWW 2024-06-14

VersaWrap

Applicant Alafair Biosciences, Inc.

K-Number K240817

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GEX 2024-06-14

Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)

Applicant Bios S.R.L.

K-Number K241407

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FRF 2024-06-14

Airdog X8 Air Purifier (KJ800F-X8)

Applicant Suzhou Beiang Smart Technology Co., Ltd.

K-Number K240696

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DXN 2024-06-14

Electronic Blood Pressure Monitor (Model: PG-800B30, PG-800B38, PG-800B39, PG-800B45, PG-800B46, PG-800B47, PG-800B48, PG-800B53, PG-800B55, PG-800B56, PG-800B57, PG-800B58, PG-800B61)

Applicant Shenzhen Pango Medical Electronics Co., Ltd.

K-Number K240729

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MQK 2024-06-14

G-Vitri Vitrification Straw

Applicant Gimbo Medical Technology Shenzhen Co., Ltd.

K-Number K240002

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OLO 2024-06-14

TELIGEN System Navigation Ready Instruments

Applicant DePuy Synthes

K-Number K233254

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QIH 2024-06-14

SIS System

Applicant Surgical Information Sciences, Inc.

K-Number K241083

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HEX 2024-06-14

Smart Scope® CX

Applicant Periwinkle Technologies Pvt., Ltd.

K-Number K233043

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IYN 2024-06-14

Clarius OB AI

Applicant Clarius Mobile Health Corp.

K-Number K233955

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KNG 2024-06-14

Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F)

Applicant Contec Medical Systems Co.,Ltd

K-Number K232893

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OLO 2024-06-14

ExcelsiusFlex

Applicant Globus Medical, Inc.

K-Number K240721

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FXX 2024-06-14

Fluidshield* 2 Fog-Free Surgical Mask (62113); Fluidshield* 2 Fog-Free Surgical Mask with Wraparound Visor (62114); Fluidshield* 2 Procedure Mask with SO SOFT* Earloops (62115); Fluidshield* 2 Procedure Mask with SO SOFT* Earloops and WrapAround Visor (62116)

Applicant Owens & Minor (O&M) Halyard, Inc.

K-Number K232812

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