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

MAX 2023-05-04

ProLift Micro Expandable Spacer System

Applicant Life Spine, Inc.

K-Number K223430

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DPW 2023-05-03

FloPatch FP120

Applicant Flosonics Medical

K-Number K223843

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JSM 2023-05-03

MedSchenker Smart Transport Medium (STM15-A/STM20-A/STM30-A/SCS30-A) System

Applicant Medschenker, Inc.

K-Number K212743

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NHA 2023-05-03

Dentis I-FIX Abutment

Applicant Dentis Co., Ltd.

K-Number K230203

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MBI 2023-05-03

Apollo Knotless Suture Anchor

Applicant Maruho Medical

K-Number K230123

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JAK 2023-05-03

Epione

Applicant Quantum Surgical Sas

K-Number K223758

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OWQ 2023-05-03

ViewFlex Eco Reprocessed ICE Catheter

Applicant ABBOTT MEDICAL

K-Number K230934

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MBI 2023-05-03

PEEK RCI Screw; Bio-Composite Screw; SignaLoc Screw

Applicant Signature Orthopaedics Pty, Ltd.

K-Number K230655

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KNS 2023-05-03

Sphincterotome

Applicant Hangzhou AGS MedTech Co., Ltd.

K-Number K222421

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EOQ 2023-05-03

BFlex 2 Slim 3.8 Single-Use Bronchoscope

Applicant Verathon Medical (Canada) Ulc

K-Number K230948

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HRS 2023-05-03

ARIX Humerus System

Applicant Jeil Medical Corporation

K-Number K230938

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PNG 2023-05-02

ASEPT Peritoneal Drainage System

Applicant Pfm Medical, Inc.

K-Number K221779

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