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

MQB 2023-06-21

1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF

Applicant Rayence Co., Ltd.

K-Number K231467

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QFG 2023-06-21

iLet® ACE Pump

Applicant Beta Bionics, Inc.

K-Number K231485

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GCJ 2023-06-21

Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control

Applicant Stryker Endoscopy

K-Number K230886

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DQK 2023-06-21

Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve Catheter (RCC-1); IOPS Guidewire (ATW-2); IOPS Tracking Pad (TP-1); IOPS Guidewire Handle (SSH-1)

Applicant Centerline Biomedical, Inc.

K-Number K230309

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PJE 2023-06-21

PAXgene® Blood DNA Tube

Applicant Preanalytix GmbH

K-Number K231469

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KDI 2023-06-21

Tablo® Hemodialysis System

Applicant Outset Medical, Inc.

K-Number K223248

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FRO 2023-06-21

Antibacterial Bandage

Applicant Winner Medical Co., Ltd.

K-Number K221311

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OWB 2023-06-20

F3

Applicant Acrew Imaging, Inc.

K-Number K222998

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LZO 2023-06-20

BethaLoc® stem cementless HA

Applicant Implantcast GmbH

K-Number K223103

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LNH 2023-06-20

HepaFatSmart (V2.0.0)

Applicant Resonance Health Analysis Services Pty, Ltd.

K-Number K231459

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FLL 2023-06-20

NC° Thermometer (Gen 3), Model Number: NCTG3

Applicant Xiamen Intretech, Inc.

K-Number K223522

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KWQ 2023-06-20

CODA Anterior Cervical Plate System

Applicant Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech

K-Number K230993

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