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
YandR System, VoluDerm Handpiece, VoluDerm Tips
Pollogen, Ltd.
Airlock® Ankle Plating System
Novastep SAS
F3D-C2 Cervical Stand-Alone System
Corelink, LLC
AVEA disposable expiratory filter/water trap (11790)
Telesair, Inc.
esolution
S4 Medical Corp.
Genius AI Detection 2.0
Hologic, Inc.
AI Platform (AIP001)
Exo, Inc.
32HQ713D
Lg Electronics.Inc
Ceribell Instant EEG Headcap (Small: C251, Medium: C252)
Ceribell, Inc.
CurrentBody Skin Led Hair Regrowth(Model: MZ-07)
Light Tree Ventures Europe B.V.
ArtiSential Laparoscopic Instruments-Electrodes
Livsmed, Inc.
PerQseal Introducers
Vivasure Medical Limited
Grivamax Family of Lasers, Models 272 and 148
Leana Orders, Inc.
Camber Sacroiliac (SI) Fixation System
Camber Spine Technologies
MINE ALNU (Model: Mine 2.1)
Hdt Co., Ltd.
InstaTRU Instant Biological Indicator for Steam (IBI-05)
True Indicating, LLC
FootHold System
Crossroads Extremity Systems, LLC
Hand-held IPL device(JOVS Graphene Hair Removal Device)
Shenzhen Qianyu Technology Co., Ltd.
CryoRobot Select System
Tmrw Life Sciences, Inc.
MiRus MoRe Lumbar Plating System
MiRus, LLC
BTL-094
BTL Industries, Inc.
AviClear Laser System
Cutera, Inc.
Healing Abutment, Cover Screw
Megagen Implant Co., Ltd.
Sterile Lancets for Single Use
Ningbo Caremed Medical Products Co., Ltd.
SurGuard3 Safety Hypodermic Needle
Terumo Europe N.V.
OvertureTi Knee Resurfacing SystemTM
Overture Orthopaedics
Boston PICO (Boston PICO)
Boston Aesthetics, Inc.
Guided Aarhus Applicator Set
Varian Medical Systems
Sovereign Posterior Cervical System
Met One Technologies, LLC
NOVA RESIN dual cure, self adhesive resin cement
Imicryl Dis Malzemeleri Sanayi VE Ticaret AS
Track 510(k) device clearances
Get notified when new devices are cleared in your category.
Set Up Free Alert