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.
Track 510(k) device clearances
Get notified when new devices are cleared in your category.
Set Up Free Alert