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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

NanoZoomer S360MD Slide scanner system

Hamamatsu Photonics K.K.

Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle

Pikdare Spa

TheraFace Microcurrent

Theragun, Inc.

EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXS

DRTECH Corporation

LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001)

Light Tree Ventures Europe B.V.

CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D)

Providence Medical Technology, Inc.

Integrity™ Implant

Anika Therapeutics, Inc.

MAMMOMAT B.brilliant

Siemens Medical Solutions USA, Inc.

ResiCem EX

Shofu Dental Corporation

EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190)

MicroVention, Inc.

Enbio S

Enbio Group AG

QStat Cartridge

Hemosonics, LLC

Zavation Connector System

Zavation Medical Products, LLC

AiORTA - Plan v2.0

ViTAA Medical Solutions, Inc.

Tigon Medical Knotless and Dual Javelin All-Suture Anchors

Tigon Medical

C.C. LIFE 21

21 Equipment S.R.L.

KMTI S141 Lumbar Interbody Fusion System

Kyocera Medical Technologies, Inc.

Stable-L Lumbar Interbody System

Nexus Spine, LLC

TrusFIL-Flow Flowable Composite Restorative

Rizhao Huge Biomaterials Company, Ltd.

Mobility Scooter (Model X-01, X-02)

Wuyi Aichi Industry & Trade Co., Ltd.

Entarik Feeding Tube System; Entarik Feeding Tube

Gravitas Medical, Inc.

Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable Contact Lens with UV Blocker

CooperVision, Inc.

FluoroDose Varnish

Centrix, Inc.

SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System

Si-Technology, LLC

FlightPlan for Liver

GE Medical Systems SCS

LCD monitor (HMD3C21S), LCD monitor (HMD5G21S)

Qingdao Hisense Medical Equipment Co., Ltd.

AFFINITY Proximal Tibia System

Techfit Digital Surgery, Inc.

Tyber Medical Anatomical Plating System

Tyber Medical, LLC

Capsulo

Quantel Medical

NaviNetics Reusable Stereotactic System (NN1000)

Navinetics, Inc.

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