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

JXM 2022-12-23

ONLINE DAT Benzodiazepines II

Applicant Roche Diagnostics

K-Number K221765

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CDD 2022-12-23

Access Vitamin B12

Applicant Beckman Coulter, Inc.

K-Number K223289

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LLZ 2022-12-23

Xenoview VDP

Applicant Polarean, Inc.

K-Number K223071

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PZM 2022-12-23

ACTOnco, ACTOnco IVD

Applicant Act Genomics

K-Number K210017

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NKB 2022-12-23

LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System.

Applicant L&K BIOMED Co., Ltd.

K-Number K223565

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LZU 2022-12-23

Visant Medical Canalicular Plug

Applicant Visant Medical, Inc.

K-Number K222164

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ODP 2022-12-22

Kodiak C Spinal Implant System

Applicant Met One Technologies, LLC

K-Number K222806

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OVE 2022-12-22

Tesera-K SC System

Applicant Kyocera Medical Technologies, Inc.

K-Number K223105

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OCL 2022-12-22

Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation Device

Applicant Medtronic, Inc.

K-Number K223508

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IRP 2022-12-22

Air Compression Leg Massager (Model: LY-670D)

Applicant Zhejiang Luyao Electronics Technology Co., Ltd.

K-Number K222949

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FRG 2022-12-22

SteriKing LT-Blueline Pouches with Tyvek

Applicant Wipak OY

K-Number K221377

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DXO 2022-12-22

TruWave Disposable Pressure Transducer

Applicant Edwards Lifesciences, LLC

K-Number K222216

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