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

OLO 2024-06-17

Robotic Integration Instruments

Applicant DePuy Synthes

K-Number K233256

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LLZ 2024-06-17

MediOMx

Applicant Pmx, Inc.

K-Number K233331

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LEL 2024-06-17

VERABAND

Applicant Arbor Medical Innovations, LLC

K-Number K233987

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GEX 2024-06-17

Medical Diode Laser (M2-GK)

Applicant Wuhan Pioon Technology Co., Ltd.

K-Number K240747

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QBD 2024-06-17

Molecular Transport Media - MTM

Applicant Alb Luz

K-Number K233324

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MNW 2024-06-15

Multi-parameter detector

Applicant Zhongshan Jinli Electronic Weighing Equipment Co., Ltd.

K-Number K231116

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BZD 2024-06-15

iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mask

Applicant Sleepnet Corporation

K-Number K241469

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DJG 2024-06-14

BioSieve Fentanyl FIA Test Kit; BioSieve ToxiSmart FIA Reader

Applicant Vivachek Biotech (Hangzhou) Co., Ltd.

K-Number K240124

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DXT 2024-06-14

Disposable High-pressure Extension Lines

Applicant Precision Medical Plastics , Ltd.

K-Number K230668

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IRP 2024-06-14

Air Pressure Therapy System (Model:VU-IPC4M)

Applicant Xiamen Weiyou Intelligent Technology Co., Ltd.

K-Number K233238

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FTM 2024-06-14

CanGaroo RM Antibacterial Envelope

Applicant Elutia, Inc.

K-Number K233991

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FGE 2024-06-14

Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZEPDS, ZPSOF, ZPSOS); Geenen® Pancreatic Stents/Stent Sets (GEPD, GPDS, GPSO, GPSOS); Johlin® Pancreatic Wedge Stent and Introducer Set (JPWS); Pushing Catheter and Guiding Catheter (GC, PC); Geenen® Sof-Flex® Pancreatic Stent (GPSO-SF. GPSOS-SF)

Applicant Cook Ireland, Ltd.

K-Number K233079

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