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

BZD 2026-01-15

Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask

Applicant Sleepnet Corporation

K-Number K251847

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LZO 2026-01-15

Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)

Applicant Maxx Orthopedics, Inc.

K-Number K253171

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GEI 2026-01-15

Ignite RF System

Applicant InMode , Ltd.

K-Number K251254

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PSZ 2026-01-15

Nano-Check Influenza A+B Test

Applicant Nano-Ditech Corporation

K-Number K252283

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PGM 2026-01-15

SDS Growing Rod

Applicant BAAT Medical Products B.V.

K-Number K251961

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ODP 2026-01-15

Curiteva Porous PEEK Cervical Interbody Fusion System

Applicant Curiteva, Inc.

K-Number K254061

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QHW 2026-01-15

Bio-Medicus Life Support Catheter and Introducer

Applicant Medtronic, Inc.

K-Number K251831

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ITI 2026-01-15

Electric Wheelchair (Robooter E80) (BBR-E80-01); Electric Wheelchair (Robooter E80) (BBR-E80-02)

Applicant Shanghai Bangbang Robotics Co., Ltd.

K-Number K253276

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LBI 2026-01-15

SnugLit(TM) Wearable Phototherapy System (SNGL-01-US)

Applicant Thera B Medical Products

K-Number K251308

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QFG 2026-01-15

MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894)

Applicant Medtronic Minimed, Inc.

K-Number K253470

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PHX 2026-01-15

AltiVate Reverse® ADLC Glenosphere

Applicant Encore Medical L.P.

K-Number K252567

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NRY 2026-01-15

Esperance pHLO Aspiration System

Applicant Phenox, Ltd.

K-Number K251357

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