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

GWO 2022-01-27

Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models), Neuro Plating System-Packaging unit(NSP-001 and 10 models), Neuro Plating System-Sterile Kit(TCN-011 and 69 models), Neuro Plating System-Screws(N15A03 and 11 models)

Applicant Osteonic Co., Ltd.

K-Number K210360

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ODP 2022-01-27

Fortilink with TiPlus Technology

Applicant Paradigm Spine

K-Number K213493

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QJI 2022-01-27

SmartAdjust technology

Applicant Insulet Corporation

K-Number K203774

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GBM 2022-01-27

Intermittent Catheter (Not Finalized)

Applicant Hollister Incorporated

K-Number K211436

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DPW 2022-01-27

VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger

Applicant Remington Medical, Inc.

K-Number K211589

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QRX 2022-01-27

Omnipod 5 SmartBolus Calculator

Applicant Insulet Corporation

K-Number K203772

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DXN 2022-01-27

RA-T59 Wrist blood pressure monitor

Applicant Lotusnine Medical Limited

K-Number K212312

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QFG 2022-01-27

Omnipod 5 ACE Pump (Pod)

Applicant Insulet Corporation

K-Number K203768

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LRK 2022-01-27

Elevo Snoring Intervention Set

Applicant Zelegent, Inc.

K-Number K213475

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PZO 2022-01-27

Sim&Size

Applicant Sim&Cure

K-Number K212373

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DXE 2022-01-27

Merlin Aspiration System

Applicant Mivi Neurovascular, Inc.

K-Number K213771

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BZG 2022-01-26

Vitalograph Model 6000 Alpha

Applicant Vitalograph Ireland, Ltd.

K-Number K212938

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