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
Nitta M&T Safety Box
Nitta M&T (Thailand) Co., Ltd.
MagnetOs MIS
Kuros Biosciences B.V
LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001
Light Tree Ventures Europe B.V.
IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave Ablation System Mobile Cart (IB-CART); I
Varian Medical Systems, Inc.
Zeta Cranial Navigation System (ZNS131-US)
Zeta Surgical, Inc.
Optiflow Oxygen Kit
Fisher & Paykel Healthcare, Ltd.
Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, And Select Other Drugs
Zhonghong Pulin Medical Products Co., Ltd.
S-Plant Dental Implant System
Newton Implant Systems, Inc.
ANSiStim-PP
Dyansys, Inc.
Dental Zirconia Ceramic
Aidite (Qinhuangdao) Technology Co., Ltd.
SUREcore Plus Biopsy Instrument
Uro-1, Inc.
TA Stapler and Loading Unit with DST Series Technology
Covidien
HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops
O&M Halyard, Inc.
SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous Catheter
Spectrum Vascular
AIM (N/A)
Inventeur, LLC
DESS Dental Smart Solutions
Terrats Medical SL
restor3d TiDAL Lumbar Interbody Fusion Device
Restor3D
EPIQ Series Diagnostic Ultrasound System
Philips Ultrasound, LLC
EnSite X EP System
Abbott
Biograph Trinion
Siemens Medical Solutions USA, Inc.
Single Use Non-Stick McPherson Bipolar Forceps, 110mm, 0.5mm Tip with Cable (HNSAG-5110M); Single Use Non-Stick Jewelle
Hg Innovations, Ltd.
OptiVu ROSA® MxR
Orthosoft Inc (D/B/A Zimmer Cas)
ORskin Blue
Megabay S.A.
babyLance Safety Heelstick (BLM, BLN, BLP)
Clinical Innovations, LLC
Ganymede 2cm diameter (FG100300); Ganymede 5cm x 5cm (FG100400); Ganymede 10cm x 10cm (FG100500); Ganymede 15cm x 15cm (
Speciality Fibres and Materials Limited
Powdered Free Sterile Natural Rubber Latex Surgical Gloves
The Egyptian Company For Medical & Electronic Industries
DeepTek CXR Analyzer v1.0
Deeptek Medical Imaging Pvt, Ltd.
DiLumen C2 and Tool Mount
Lumendi, LLC
VariFuse Adjustable Infusion Catheter
Argon Medical Devices, Inc.
Comfort Gown, Safewear Gown
Xuchang Zhengde Environstar Medical Products Co., Ltd.
Track 510(k) device clearances
Get notified when new devices are cleared in your category.
Set Up Free Alert