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
Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant
Promimic AB
87 NeuGlide Catheter
Piraeus Medical
Nitrile Patient Examination Glove
Pingan Medical Products Co., Ltd.
REMEX-GR100
Remedi Co., Ltd.
DWFritz ASM2000
Dwfritz Automation, Inc.
Dental sensors NanoPix1, NanoPix2
Iray Technology Taicang , Ltd.
Geistlich Bio-Oss®
Geistlich Pharma AG
OneLIF Intervertebral Body Replacement System
Novapproach Spine
XERF
Lutronic Corporation
BruxZir Incisal Coloring Liquid
Prismatik Dentalcraft, Inc.
Disposable Face Mask
Chaozhou Cecilia Technology Co., Ltd.
Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX
Blue Sky Bio, LLC
Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System
Aegis Spine, Inc.
CareSuperb COVID-19/Flu A&B Antigen Combo Home Test
Access Bio, Inc.
VersiHD with GuideMe software
Nxstage Medical, Inc.
Anatase Spine Surgery Navigation System
Remex Medical Corp.
SEFRIA Hydrocodone Oral Fluid
Immunalysis Corporation
LOQTEQ Proximal Humerus Plate 3.5 System
Aap Implantate AG
Sonosite LX and Sonosite PX Ultrasound Systems
FUJIFILM Sonosite, Inc.
SIGNA PET/MR
Ge Medical Systems, LLC
Excelsior
Merit Cro, Inc.
BriefCase
Aidoc Medical , Ltd.
Pantheon Pedicle Screw and Iliac Bolt Fixation System
Pantheon Spinal
HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System
Hospital Equipment Manufacturing Company
Power Wheelchair (N5909)
Zhejiang Innuovo Rehabilitation Devices Co.,Ltd
ARISTE AB Mesh
Ariste Medical, LLC
OPXION Optical Skin Viewer (OPXSV1-01F)
Opxion Technology, Inc.
i3 Foldable Mobility Scooter
Puc Perfect Union Co., Ltd.
IRIS-XP
Medicore Co., Ltd.
BIOTEQ Drainage Catheter BT-PDS-series
Bioteque Corporation
Track 510(k) device clearances
Get notified when new devices are cleared in your category.
Set Up Free Alert