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

OCW 2023-08-31

MedicloseTM System

Applicant Health Value Creation B.V., Trading AS Corporis Medical

K-Number K213271

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SBF 2023-08-31

HOLO Portal™ Surgical Guidance System

Applicant Surgalign Spine Technologies

K-Number K231611

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GWQ 2023-08-31

Q21

Applicant Neurofield, Inc.

K-Number K221959

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HWC 2023-08-30

Nexis® compressive screws

Applicant Novastep

K-Number K223468

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PZP 2023-08-30

AquaBeam Robotic System

Applicant Procept Biorobotics, Corporation

K-Number K231024

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ETN 2023-08-30

NIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35)

Applicant Medtronic Xomed, Inc.

K-Number K231580

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MTJ 2023-08-30

MONTAGE Settable, Resorbable Hemostatic Bone Putty

Applicant Orthocon, Inc.

K-Number K213418

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GEI 2023-08-30

Spinery™ RF Ablation System

Applicant Axon Spine Medical System

K-Number K223303

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JAQ 2023-08-30

Mick Valencia Applicator Set

Applicant Mick Radio-Nuclear Instruments, Inc.

K-Number K230155

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CAF 2023-08-30

Ochsner Connected Inhaler Sensor

Applicant Ochsner Clinic Foundation

K-Number K223367

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LRX 2023-08-30

Phoenix Contact Lens Case - dome top flat pack (CL-01); Phoenix Contact Lens Case - classic flat pack (CL-02); Phoenix Contact Lens Case - sunglass shape flat pack (CL-03)

Applicant Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd.

K-Number K231123

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DSH 2023-08-30

S-Patch Ex Wearable ECG Patch

Applicant Wellysis Corp.

K-Number K231289

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