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

PKT 2022-09-23

Diosculpt

Applicant Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd

K-Number K222265

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PDQ 2022-09-23

ATEC IOM Accessory Instruments

Applicant Alphatec Spine, Inc.

K-Number K221821

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OVD 2022-09-23

Align

Applicant Acuity Surgical Devices, LLC

K-Number K222561

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EBF 2022-09-23

DENU Composite Resin, DENU Flow Resin

Applicant Hdi, Inc.

K-Number K213339

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OBJ 2022-09-23

OptiCross™ 18 Peripheral Imaging Catheter

Applicant Boston Scientific Corporation

K-Number K222568

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NUC 2022-09-23

Wet Flavored Personal Lubricants

Applicant Trigg Laboratories, Inc.

K-Number K221829

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ONO 2022-09-22

TRANBERG Thermoguide Therapy System

Applicant Clinical Laserthermia Systems, AB

K-Number K214125

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EMA 2022-09-22

GlasIonomer FX ULTRA

Applicant Shofu Dental Corporation

K-Number K222253

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GEI 2022-09-22

CellFX System

Applicant Pulse Biosciences, Inc.

K-Number K213674

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FTL 2022-09-22

ProGrip Self-Gripping Polypropylene Mesh

Applicant Covidien

K-Number K220540

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GEX 2022-09-22

Dual Switch

Applicant Laser Engineering, Inc.

K-Number K211605

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FQH 2022-09-22

Irrisept Antimicrobial Wound Lavage

Applicant Irrimax Corporation

K-Number K222804

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