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

FlowTriever2 Catheter

Inari Medical, Inc.

Ultrasound Transmission Gels

Hony Medical Co., Ltd.

FINDER Flu A&B/SARS-CoV-2 Test

Baebies, Inc.

Voluson Expert 18; Voluson Expert 20; Voluson Expert 22

GE Medical Systems Ultrasound and Primary care Diagnostics, LLC

Syncron-E

Autonomous Healthcare, Inc.

21.3” 5MP Color LCD Display UMD5-21B01

Acula Technology Corp.

DynaFlex Clear Brackets & Buttons

Dyna Flex

Trevo NXT ProVue Retriever

Stryker Neurovascular

S-scan Open (100001800)

Esaote, S.p.A.

MagnetOs Easypack Putty

Kuros Biosciences B.V

HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining (39123), HALYARD* FLUIDSHIELD* 2 Surgic

Owens & Minor (O&M) Halyard, Inc.

VIVIX-S 1751S

Vieworks Co., Ltd.

Universal CMF System

Stryker Leibinger GmbH & Co KG

Disposable Automatic Core Biopsy Instrument

Suzhou Leapmed Healthcare Corporation

Break Wave

Sonomotion, Inc.

DIMPLO Implant System

DIMPLO, Ltd.

RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm

Ureteral Stent Company

TDM Screw System

Tdm Co., Ltd.

Insulin syringe with integrated needle DL

Dlp Medical Products, Corp.

INSPIRA ART100

Inspira Technologies Oxy B.H.N. , Ltd.

iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material ;iRoot BP Plus Root Repair Mater

Innovative Bioceramix, Inc.

CARTO 3 EP Navigation System Version 7.2

Biosense Webster, Inc.

Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50

Thermo Fisher Scientific (Oxoid Ltd.)

S-Line

Barkey GmbH & Co. KG

Garion Image-Intensified Fluoroscopic X-Ray System, Mobile

Sg Healthcare Co, Ltd.

Medwell Technology Ltd Syringes, various sizes

Medwell Technology, Ltd.

Prism

Graymatters Health , Ltd.

ATTUNE Total Knee System; ATTUNE Cementless Knee System

DePuy Ireland UC

Bluemoon

Genoss Co., Ltd.

Reusable SmartPeg

Osstell AB

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