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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

PreXion3D Expedition

Prexion Corporation

AURORA Evacuator +Coag

Rebound Therapeutics

Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post

Total Joint Othopedics, Inc.

Solo+ Tympanostomy Tube Device (TTD)

Aventamed Dac

YandR System, VoluDerm Handpiece, VoluDerm Tips

Pollogen, Ltd.

Plasonic (Plasonic)

Hironic Co., Ltd.

Brainomix 360 Hyperdensity

Brainomix Limited

Getinge Assured MI Steam Migrating Integrator

Steritec Products Mfg. (A Getinge Group Company)

All-Suture Anchor

Riverpoint Medical, LLC

EXTesia Introducer Sheath Set

Curatia Medical Co.

STARband 3D

Orthomerica Products, Inc.

Panther 5

Origin Medical Devices

Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens

Innova Vision, Inc.

Wheelchair (N817)

Zhejiang Topwe Tools Manufacturing Co.,Ltd

Radius VSM and Accessories

Masimo Corporation

aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion device; aprevo® anterior lumbar

Carlsmed, Inc.

Leonardo Duster

Ceramoptec GmbH

TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System

Life Spine, Inc.

TitanPico Laser Workstation (PICO-450)

Rhein Laser Technologies Co., Ltd.

Surgical and Prosthetic Trays

Dentsply Sirona

ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire

Cordis Corporation

SCENARIA View Phase 5.0

Fujifilm Corporation

Wearable Breast Pump (Model S18)

Shenzhen TPH Technology Co., Ltd.

PeekMed web

Peek Health, S.A.

S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)

Mevion Medical Systems, Inc.

4K NIR/ICG Imaging System

Zhejiang Healnoc Technology Co., Ltd.

OptiVu™ Shoulder

Mr Surgical Solutions, LLC

Béa Applicator (BAP-GB-01)

Stepone Fertility Ltd (T/A Béa Fertility)

Happy Health Home Sleep Test

Happy Health, Inc.

Encevis

Austrian Institute of Technology GmbH

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