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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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