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
Stryker VariAx 2 MIS Calcaneus
Stryker GmbH
Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C-CAE-14.0-70-FI); Frova Intubating Introd
William Cook Europe Aps
ADVIA Centaur EBV-VCA IgM
Biokit, S.A.
iLet® Dosing Decision Software
Beta Bionics, Inc.
x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology)
De Götzen S.R.L.
NIRVANA
El.En S.P.A.
HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta Advanced Monitor (Smart Recovery); HemoSphere Alta Advan
Edwards Lifesciences, LLC
Diode laser device (RF3120-BI)
Risu Medical Technology Co., Ltd.
da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)
Intuitive Surgical
Alcon (serafilcon A) soft contact lenses for daily wear
Alcon Laboratories, Inc.
ERI Handheld Dental X-ray System (Model AG100)
Energy Resources International Co., Ltd. Hsinchu Branch
Disposable Vinyl Examination Gloves
Tangshan Hongyun Healthcare Products Co., Ltd.
Vivo 45 LS
Breas Medical AB
FAICO Dental Implant System and CAD/CAM Abutments
Faico Medical, LLC
Iconic Latex Glove
Iconic Medicare Sdn Bhd
Purema H Hemoconcentrator - Pediatric
Medica USA, Inc.
Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible
Micro-Tech (Nanjing) Co., Ltd.
Electric wheelchair (S7018)
Guangdong Prestige Technology Company Limited
Spectral CT Verida Family
Philips Medical Systems Technologies , Ltd.
Armis VeriCyn Wound Wash
Armis Biopharma, Inc.
Sublime Microcatheter
Surmodics,Inc.
Revitalair 430+
Us Hyperbaric Network
Annabella Double Breast Pump (ADO-US23-1000)
Annabella Tech
HRSpheres Narrow-Size Embolic Microspheres
Suzhou Hengrui Hongyuan Medical Co., Ltd.
Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, L
Bonebridge AG
ADDNOX (BPSPM1)
Nu Eyne Co., Ltd.
DOLORCLAST Focused Shock Waves
E.M.S Electro Medical Systems S.A
Intensity Pulsed Light Therapy System
Beijing Adss Development Co., Ltd.
HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops
O&M Halyard, Inc.
BentrioTM Allergy Blocker
Altamira Therapeutics, Inc.
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