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

HSN 2022-11-17

MAVEN™ Patient-Specific Instrumentation

Applicant Paragon 28, Inc.

K-Number K223227

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SBF 2022-11-17

xvision Spine System

Applicant Augmedics, Ltd.

K-Number K220905

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GEI 2022-11-17

Supra Non-Stick Bipolar Forceps

Applicant Guenter Bissinger Medizintechnik GmbH

K-Number K213042

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GYD 2022-11-17

Parky App

Applicant H2o Bilisim Yazilim

K-Number K220820

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EZD 2022-11-17

Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus

Applicant Convatec, Inc.

K-Number K221593

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FMI 2022-11-17

Disposable Insulin Pen Needle

Applicant Ningbo Medsun Medical Co., Ltd.

K-Number K221178

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PBX 2022-11-17

C.C. LIFE 21

Applicant 21 Equipment S.R.L.

K-Number K213295

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JSM 2022-11-17

Disposable Urine Collection Tube

Applicant Zhejiang Gongdong Medical Technology Co., Ltd.

K-Number K220739

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DZE 2022-11-16

PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)

Applicant Dentsply Sirona

K-Number K220841

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FXX 2022-11-16

Disposable surgical face mask

Applicant Shandong Aida Medical Products Co., Ltd.

K-Number K220302

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CCK 2022-11-16

Endoscopy Oxygen Mask

Applicant Engineered Medical Systems, Inc.

K-Number K220533

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DWC 2022-11-16

Heater-Cooler System 3T

Applicant Livanova Deutschland, GmbH

K-Number K220635

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