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

MUH 2023-11-21

DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2 Intraoral Sensor

Applicant Dental Imaging Technologies Corporation

K-Number K233053

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PSW 2023-11-21

TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant with QwikCheck™ Chemical Indicator

Applicant Cs Medical, LLC

K-Number K233049

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DXT 2023-11-21

High Pressure Tubing

Applicant Ningbo Dizegens Medical Science Co.,Ltd

K-Number K232388

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OWN 2023-11-21

KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit

Applicant Karl Storz SE & CO. KG

K-Number K233333

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NHA 2023-11-21

Meta G UCLA Abutment

Applicant Cowellmedi Co., Ltd.

K-Number K232546

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OCX 2023-11-21

Endoscopy Irrigation Tubing

Applicant Zhejiang Chuangxiang Medical Technology Co., Ltd.

K-Number K230773

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PJD 2023-11-21

Quantisal™ Oral Fluid Collection Device

Applicant Immunalysis Corporation

K-Number K232898

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DQO 2023-11-21

INFINITI™ Ambi Angiographic Catheter

Applicant Cordis US Corp

K-Number K232573

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OVE 2023-11-21

TotalTi ACDF by SAGICO

Applicant Spinal Analytics & Geometrical Implant Co, LLC

K-Number K233191

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DPS 2023-11-21

CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800H

Applicant Trismed Co., Ltd.

K-Number K230834

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QAS 2023-11-21

Brainomix 360 Triage Stroke

Applicant Brainomix Limited

K-Number K232496

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ELC 2023-11-21

Ultrasonic Scaler Tips

Applicant Guilin Refine Medical Instrument Co., Ltd.

K-Number K230641

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