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

LLZ 2024-10-23

MIM – Symphony HDR Fusion

Applicant Mim Software, Inc.

K-Number K243012

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ONB 2024-10-23

ProSeal™ Closed System Bag Access

Applicant Epic Medical Pte. , Ltd.

K-Number K241988

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QYM 2024-10-23

STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS)

Applicant Tsk Laboratory International Japan KK

K-Number K242073

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MUJ 2024-10-23

TrueFit Bolus; TrueFlex Bolus

Applicant Adaptiiv Medical Technologies, Inc.

K-Number K243057

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DZE 2024-10-23

Immediate Molar Implants

Applicant Biomet 3i, LLC

K-Number K241753

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GCJ 2024-10-23

FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K)

Applicant Guangdong Optomedic Technologies, Inc.

K-Number K242513

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FET 2024-10-22

Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100)

Applicant Shanghai SeeGen Photoelectric Technology Co., Ltd.

K-Number K241532

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HQD 2024-10-22

SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses

Applicant Tianjin Mastervision Technology Co., Ltd.

K-Number K241398

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NLF 2024-10-22

Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001); Reprocessed RD SET Inf Pulse Oximeter Sensor (4002); Reprocessed RD SET Adt Pulse Oximeter Sensor (4003)

Applicant Stryker Sustainability Solutions

K-Number K241758

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DXN 2024-10-22

Arm Type Blood Pressure Monitor (BPM82)

Applicant Avita Corporation

K-Number K242193

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LLZ 2024-10-22

nordicMEDiVA

Applicant Nordicneurolab AS

K-Number K243209

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PNO 2024-10-22

Tri-Wedge PTA Scoring Balloon Dilatation Catheter

Applicant Brosmed Medical Co., Ltd.

K-Number K241478

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