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

Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed Ecstasy)

Church & Dwight Co., Inc.

Oxygen Concentrator (J5A)

Foshan Kycare Medical Equipment Co., Ltd.

True Non-Surgical Spinal Decompression System (DRX9000-SL)

Excite Medical of Tampa Bay, LLC

CATS-L Tonometer™ Prism

Cats Tonometer, LLC

VITA YZ Multi Translucent

Vita Zahnfabrik H.Rauter GmbH & Co.

RAYSCAN a-Expert3D

Ray Co., Ltd.

Pearl Clear Aligner

Pearl Digital, Inc.

Tigertriever 25 Revascularization Device

Rapid Medical Ltd.

HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter))

Gentuity, LLC

myAir

Resmed Corp

Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42))

Guangdong Youmeng Electrical Technology Co., Ltd.

Natus Ultrapro S100 (982A0594)

Natus Neurology Incorporated

Exeter® X3® RimFit® Cup

Howmedica Osteonics Corp., Dba Stryker Orthopaedics

Mural Clinical Viewer

Ge Medical Systems Information Technologies, Inc.

Kogent Disposable Copper Forceps, Kogent Disposable Irrigating Copper Forceps, Kogent Disposable Illuminating Copper For

Katalyst Surgical, LLC

Elecsys Testosterone II

Roche Diagnostics

Esthetic Colorant

Kuraray Noritake Dental, Inc.

Mimics Thoracic Planner

Materialise NV

LVivo IQS

Dia Imaging Analysis, Ltd.

Y-Knotless™ Flex Anchors

CONMED Corporation

Accu-Chek Safe-T-Pro Uno Lancing Device

Roche Diabetes Care, Inc.

Luja Set

Coloplast Corp.

OFIX MIS App

Orthofix US, LLC

Eclipse Treatment Planning System (v18.0)

Varian Medical Systems, Inc.

Antimicrobial Silicone PHMB Foam Wound Dressing

Advanced Medical Solutions Limited

Premier's MultiMatch Universal Chameleon Restorative Composite

Premier Dental Products Company

MSFX Mikron Cervical Anterior Plate System

Mikron Makina Sanayi VE Ticaret Ltd. Sti.

Digital Routines

Gnc Holdings, LLC

Catalyst R1 Reverse Shoulder System

Catalyst Orthoscience, Inc.

Arc Adjustable Radial Cuff Compression Device

Tz Medical, Inc.

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