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
ROTEM sigma Thromboelastometry System
Tem Innovations GmbH
Powered Wheelchair (PL001-9001)
Suzhou KD Intelligent Device Co., Ltd.
DEFINE System (AG612444A)
InMode , Ltd.
Freedom Posterior Cervical Screws
Signature Orthopaedics Pty, Ltd.
Disposable surgical mask
Shanghai No.9 Knitting Mill Co., Ltd.
Monarch Platform, Urology
Auris Health, Inc.
TDM Large Bone Plate and Screw System
Tdm Co., Ltd.
Elevo Snoring Intervention Set
Zelegent, Inc.
Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set, Ambu aScope 5 Broncho HD 5.0/2.2 Sampler Set
Ambu A/S
Depth Electrode (RSDE-08); Depth Electrode (RSDE-10); Depth Electrode (RSDE-12); Depth Electrode (RSDE-14); Depth El
Beijing Sinovation Medical Technology Co., Ltd.
Humask Pro Vision, Humask Pro Vision 3000
Entreprise Premont, Inc.
Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 F
Siemens Medical Solutions USA, Inc.
NATtrol BD MAX Vaginal Panel External Controls
Zeptometrix
Healgen Strep A Rapid Test Strip (Throat Swab)
Healgen Scientific,, LLC
Francisella tularensis Real-time PCR Assay
Centers for Disease Control and Prevention
HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable, HemoSphere Pressure Cable, HemoSphe
Edwards Lifesciences, LLC
OTS Hip
Ortoma AB
IRRAflow Active Fluid Exchange System (AFES)
Irras USA
PuraStat
3-D Matrix Europe SAS
AHI System
Fifth Eye, Inc.
JETi AIO Peripheral Thrombectomy System
Walk Vascular, LLC
Biograph Vision Quadra PET/CT System
Siemens Medical Solutions USA, Inc.
Upper Arm Blood Pressure Monitor
Shenzhen Yolanda Technology Co., Ltd.
TriVerse Total Knee Replacement System
Signature Orthopaedics Pty, Ltd.
DEKA HELIX
El.En Electronic Engineering Spa
FFX Facet Fixation System
Sc Medica
Cleaner Plus Thrombectomy System, Cleaner Plus Aspiration Catheter, Cleaner Plus Handpiece with 65cm Maceration Wire,
Argon Medical Devices, Inc.
Ultraflex Tracheobronchial Stent System
Boston Scientific Corporation
EzRay Air 2 Wall (Model: VEX-S350W)
VATECH Co., Ltd.
Intraosseous Fusion Device System
Auxano Medical, LLC
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