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

BSP 2022-07-01

BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural Needle

Applicant Becton, Dickinson and Company

K-Number K211085

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DQK 2022-07-01

AcQMap High Resolution Imaging and Mapping System

Applicant Acutus Medical, Inc.

K-Number K220784

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KNW 2022-07-01

NovaCore Semi-Automatic Biopsy Instrument

Applicant Argon Medical Devices

K-Number K213232

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KRD 2022-07-01

GEM

Applicant Obsidio, Inc.

K-Number K213385

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DZE 2022-06-30

Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK temporary abutments

Applicant Blue Sky Bio, LLC

K-Number K212785

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DXN 2022-06-30

Wrist Type Blood Pressure Monitor

Applicant Shenzhen Jamr Medical Technology Co., Ltd.

K-Number K220651

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OUR 2022-06-30

ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema Lumbar Plate System

Applicant Aegis Spine, Inc.

K-Number K221050

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HIR 2022-06-30

leva Pelvic Health System

Applicant Renovia, Inc.

K-Number K213913

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CHH 2022-06-30

Cholesterol2

Applicant Abbott Ireland Diagnostics Division

K-Number K203597

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FXX 2022-06-30

Sparta 3-Ply Surgical Disposable Face Mask

Applicant Sparta East, LLC

K-Number K220378

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DQY 2022-06-30

CPS AIM Universal II Slittable Inner Catheter

Applicant ABBOTT MEDICAL

K-Number K221750

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GEX 2022-06-30

InMode Multi-system

Applicant InMode , Ltd.

K-Number K221571

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