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

NAY 2024-06-04

da Vinci SP Surgical System (SP1098)

Applicant Intuitive Surgical, Inc.

K-Number K232773

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MQC 2024-06-04

Slow Wave DS8 (SWDS802)

Applicant Slow Wave, Inc.

K-Number K240463

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NKB 2024-06-04

Ingenix Spinal System

Applicant Ingenium Spine

K-Number K241258

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FXX 2024-06-04

HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806)

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

K-Number K232820

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ONO 2024-06-04

Monteris Medical NeuroBlate System

Applicant Monteris Medical,

K-Number K240877

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OUR 2024-06-04

Eminent Spine SI Screw System

Applicant Eminent Spine, LLC

K-Number K240505

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GEX 2024-06-04

Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024)

Applicant Aesthetic Technology, Ltd.

K-Number K240222

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MAI 2024-06-04

Arthrex AlloSync PushLock Suture Anchor

Applicant Arthrex, Inc.

K-Number K233971

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LZO 2024-06-03

EcoFit® short stem cementless cpTi

Applicant Implantcast GmbH

K-Number K240834

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DRG 2024-06-03

ANNE Chest

Applicant Sibel Health, Inc.

K-Number K240251

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KCT 2024-06-03

Perforated Baskets

Applicant Richard Wolf Medical Instruments Corporation

K-Number K231291

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NHA 2024-06-03

LOCATOR Angled Abutment (Various)

Applicant Zest Anchors, LLC

K-Number K233587

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