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

HSB 2023-03-06

Pro-X1™ Trochanteric Nailing System

Applicant X-Bolt Orthopedics

K-Number K221621

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DZE 2023-03-06

Provata Implant System

Applicant Southern Implants (Pty), Ltd.

K-Number K222457

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EBF 2023-03-06

LC ChromeFlow

Applicant S&C Polymer Silicon- Und Composite Spezialitaten GmbH

K-Number K222445

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CBN 2023-03-05

Nitronox Scavenger Plus

Applicant Parker Hannifin Corporation

K-Number K223452

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FDI 2023-03-03

Polypectomy Snare

Applicant Hangzhou AGS MedTech Co., Ltd.

K-Number K221713

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QBJ 2023-03-03

FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose Monitoring System

Applicant Abbott Diabetes Care, Inc.

K-Number K222447

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JAK 2023-03-03

Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i

Applicant Canon Medical Systems Corporation

K-Number K222819

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LLZ 2023-03-03

CoverScan (CoverScan v1.1)

Applicant Perspectum

K-Number K230294

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KPO 2023-03-03

NIKKICART

Applicant Renal Care Dialysis Solutions, S.A. DE C.V.

K-Number K221652

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DXC 2023-03-03

Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)

Applicant Compression Works, Inc.

K-Number K221661

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DWM 2023-03-03

Aspira Pleural Drainage System

Applicant Merit Medical Systems, Inc.

K-Number K212696

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KLE 2023-03-03

EZ Bond Universal

Applicant Meta Biomed Co., Ltd.

K-Number K230009

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