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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