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

ErgoSteel (ES0001/696)

Strongback Mobility AG C/O Blueaudit GmbH

Ziehm Solo FD

Ziehm Imaging GmbH

CREED™ Cannulated Screws

Glw, Inc.

StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse Deflection

Boston Scientific Corporation -

InThrill™ Thrombectomy System

Inari Medical, Inc.

XeliteMed VertehighFix High Viscosity Spinal Bone Cement

Xelite Biomed , Ltd.

DTX Studio Assist

Nobel Biocare C/O Medicim NV

Elos Accurate Hybrid Base

Elos Medtech Pinol A/S

EyeBOX EBX-4.1

Oculogica, Inc.

SurfRider 13 Microcatheter

Kaneka Americas Holding, Inc.

Radiance V5

Gmv Soluciones Globales Internet S.A.U.

Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B12A 4.6/2.0; Insighters™ Single-use Bronchoscope/Insigh

Shenzhen Insighters Medical Technology Co., Ltd.

SiteRite™ 9 Ultrasound System

Bard Access Systems, Inc. (C.R. Bard, Inc.)

Zeta Cranial Navigation System

Zeta Surgical

Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl

Xingyu Medical Tech Co., Ltd.

The Circadia C200 System

Circadia Technologies, Ltd.

Medical Image Post-processing Software (uOmnispace.CT)

Shanghai United Imaging Healthcare Co., Ltd.

BTL-995-rTMS

BTL Industries, Inc.

SM-V

Sedecal., Sa.

Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System

Stryker GmbH

Savvy Surgical Mask - Level 3

Alg Health, LLC

Imagine® Enterprise Suite

Softlink International Private Limited

Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System

Canon Medical Systems Corporation

Hintermann Series H2 Total Ankle System

Vilex, LLC

Baby Gorilla®/Gorilla® Plating System

Paragon 28, Inc.

Galen ES Cooperative Surgical Assistant Platform, Galen ES

Galen Robotics

SOTA Cloud Smart Sensor (1.5)

Sota Cloud Corp.

TearCare MGX System

Sight Sciences, Inc.

ARIX Ankle System

Jeil Medical Corporation

Kentrospine Viktr-MIS® Pedicle screw system

Rivarp Medical Pvt., Ltd.

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