RecallHawk

510(k) Device Clearances

Medical devices cleared through the FDA's 510(k) premarket notification process. Substantially equivalent to existing devices.

15,000 total clearances

Hilzo Esophageal Stents

Thoracent, Inc.

KARL STORZ Flexible Intubation Video Endoscope – Sterile (FIVE-S) (0916612)

Karl Storz SE & CO. KG

Evoblock, Perléon

Evoden Indústria Comércio Importação E Exportação

WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully Covered Stent System RMV

Boston Scientific

HYDRASHIFT 2/4 isatuximab

Sebia

da Vinci E-200 Electrosurgical Generator

Intuitive Surgical

SpyGlass Discover Balloon Dilation Catheter

Boston Scientific Corporation

nordicAudio (1.0)

Nordicneurolab AS

Neodent Implant System - Custom Abutments

Jjgc Indústria E Comércia DE Materiais Dentários S.A.

Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P

Ge Medical Systems Information Technologies, Inc.

TRAUS ENDO

Saeshin Precision Co., Ltd.

OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation Nail

OSSIO , Ltd.

DeepCatch

Medical IP Co., Ltd.

Mimics Cardiac Planner

Materialise NV

Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood Lancet (Softsure Pro); Disposab

SteriLance Medical (Suzhou), Inc.

MOTUS PRO Family

El.En S.P.A.

The Botticelli (Model: Athena)

Bellamia Technologies, Inc.

Blood Volume Analyzer (200)

Daxor Corporation

Logical Liner; World Liner; World Knee Patella

Signature Orthopaedics Pty, Ltd.

Core Metabolic

Truvian Health

ABPMpro

Somnomedics GmbH

Powder Free Nitrile Examination Gloves (Blue, Black, Indigo)

Ammex Corporation

LIAISON PLEX Yeast Blood Culture Assay

Luminex Corporation

Ultrasonic Surgical & Electrosurgical Generator

Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.

Delphi Stimulator

Quantalx Neuroscience

iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement System

Conformis, Inc.

Denti.AI Detect

Denti.Ai Technology, Inc.

da Vinci Surgical System, Model IS5000

Intuitive Surgical, Inc.

Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS)

Us Medical Innovations, LLC

Hoffmann LRF System

Stryker GmbH

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