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

OHT 2024-07-10

IPL Hair Removal Device (YT01,YT02,YT03,YT04)

Applicant Shenzhen Jianrong Biomedical Electronics Co., Ltd.

K-Number K240016

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BZD 2024-07-10

Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Mask; V3 Full Face Vented Mask

Applicant Sleepnet Corporation

K-Number K241661

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PFO 2024-07-10

Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS

Applicant Oticon Medical AB

K-Number K240614

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DTZ 2024-07-10

Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811); Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface (BB841); Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface NON STERILE (BB811-NS)

Applicant Medtronic Perfusion Systems

K-Number K240666

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SBS 2024-07-10

Lightin System, Lightin, Lightin Generator

Applicant Solmedix Co., Ltd.

K-Number K232177

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FMF 2024-07-10

GPS Advanced; 5 cc GPS Advanced Cannula

Applicant Prosidyan, Inc.

K-Number K241426

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NEU 2024-07-10

HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6)

Applicant Devicor Medical Products, Inc.

K-Number K240527

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JAQ 2024-07-10

AOS Interstitial Templates, Needles, and Accessories

Applicant Alpha-Omega Services, Inc.

K-Number K233628

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MTD 2024-07-09

Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™

Applicant ABBOTT MEDICAL

K-Number K241372

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NQQ 2024-07-09

deepLive

Applicant Damae Medical

K-Number K240610

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PZL 2024-07-09

OW100S

Applicant Softwave/Trt, LLC

K-Number K233937

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DZE 2024-07-09

Prima Plus Conical Implant System

Applicant Keystone Dental, Inc.

K-Number K240966

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