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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