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

GAT 2021-05-03

EasyWhip

Applicant Winter Innovations, Inc.

K-Number K210675

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IPF 2021-05-03

Storz Medical MAGNETOLITH Muscle Stimulator

Applicant Storz Medical AG

K-Number K203710

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CBI 2021-05-03

Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable

Applicant Ambu A/S

K-Number K203749

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KOI 2021-05-02

Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series

Applicant Nihon Kohden Corporation

K-Number K201949

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OXH 2021-05-02

Kerecis Reconstruct

Applicant Kerecis Limited

K-Number K202430

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JDO 2021-04-30

OsteoCentric Integrated Hip Fastener System

Applicant Osteocentric Technologies D.B.A. Osteocentric Trauma

K-Number K210247

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OWW 2021-04-30

The BioBrace Implant

Applicant Biorez, Inc.

K-Number K203267

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BZD 2021-04-30

Innova Nasal Non-Vented Mask

Applicant Sleepnet Corporation

K-Number K203601

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QEW 2021-04-30

FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16, Triever 20, Triever 20 Curve, Triever 24

Applicant Inari Medical, Inc.

K-Number K211013

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NKB 2021-04-30

CD Horizon Spinal System

Applicant Medtronic

K-Number K210637

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DPS 2021-04-30

MAC 7 - Resting ECG Analysis System

Applicant Ge Medical Systems Information Technologies, Inc.

K-Number K203786

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KPS 2021-04-30

HYPER AiR

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K210001

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