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

FDF 2022-04-01

Saneso Colonoscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without Dual Band Imaging(DBI)), Saneso Single Camera Colonoscope-A (Model: with/without Select Band Imaging (SBI)), Saneso Gastroscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without Dual Band Imaging(DBI)), Saneso Single Camera Gastroscope-A (Model: with/without Select Band Imaging (SBI))

Applicant Saneso, Inc.

K-Number K210052

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MHX 2022-04-01

Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P

Applicant Ge Medical Systems Information Technologies, Inc.

K-Number K213490

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NUH 2022-04-01

TENS & PMS Unit

Applicant Shenzhen Yuehua Xinsen Technology Co., Ltd.

K-Number K220005

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NHA 2022-04-01

MIS Angulated multi-unit abutments

Applicant Dentsply Sirona

K-Number K213432

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OVD 2022-04-01

Dakota ALIF System

Applicant Precision Spine, Inc.

K-Number K213118

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NWB 2022-04-01

HD-550 Video Endoscope System

Applicant Sonoscape Medical Corp.

K-Number K211882

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JWH 2022-04-01

EMPOWR Revision Knee

Applicant Encore Medical L.P.

K-Number K213793

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LNH 2022-04-01

MAGNETOM Avanto Fit

Applicant Siemens Medical Solutions USA, Inc.

K-Number K220151

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KPR 2022-04-01

SKANRAD 400

Applicant Skanray Technologies Limited

K-Number K220518

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DYB 2022-04-01

Intri24 Sheath

Applicant Inari Medical, Inc.

K-Number K212392

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MMX 2022-04-01

Aveir Retrieval Catheter

Applicant ABBOTT MEDICAL

K-Number K213494

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NVP 2022-04-01

LiteAire Basic Dual-Valved, Collapsible MDI Holding Chamber

Applicant Thayer Medical Corporation

K-Number K210558

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