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

LBE 2023-08-31

Little Wave Arc; Little Wave Flip

Applicant Ki Mobility, LLC

K-Number K223533

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IOR 2023-08-31

Little Wave Clik, Rogue XP, Little Wave XP, Spark

Applicant Ki Mobility, LLC

K-Number K223527

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LZA 2023-08-31

Powder Free Nitrile Examination Gloves (Black)

Applicant Shanxi Hongjin Plastic Technology Co., Ltd.

K-Number K232353

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QAZ 2023-08-31

23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)

Applicant 23AndMe, Inc.

K-Number K223597

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FDA 2023-08-31

Ancora-SB

Applicant Aspero Medical, Inc.

K-Number K231323

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KGO 2023-08-31

Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl

Applicant Wrp Asia Pacific Sdn. Bhd.

K-Number K230578

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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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