FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
11473–11496 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 16, 2023
Electric Wheelchair
K223393 · ITI
Shanghai Bangbang Robotics Co., Ltd.
Physical Medicine · 128d
Cleared Mar 16, 2023
Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0,...
K223154 · OBP
Magstim Company, Ltd.
Neurology · 161d
Cleared Mar 16, 2023
Senhance Surgical System
K223095 · NAY
Asensus Surgical, Inc.
General & Plastic Surgery · 167d
Cleared Mar 16, 2023
MilkMate Breast Pump
K223084 · HGX
Milkmate Products, Inc.
Obstetrics & Gynecology · 167d
Cleared Mar 16, 2023
EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System,...
K222839 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 177d
Cleared Mar 16, 2023
iSyncBrain©-C
K222838 · OLU
iMediSync, Inc.
Neurology · 177d
Cleared Mar 16, 2023
Nitrile Examination Gloves
K222813 · LZA
Ecoglove Medical Manufacturing...
General Hospital · 178d
Cleared Mar 16, 2023
Ensmile
K222619 · NXC
Ensmile Pvt, Ltd.
Dental · 198d
Cleared Mar 16, 2023
Sterile Silver Alginate Wound Dressing
K220673 · FRO
Qingdao Bright Moon Biomedical...
General & Plastic Surgery · 374d
Cleared Mar 15, 2023
LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001)
K230124 · OHS
Light Tree Ventures Europe B.V.
General & Plastic Surgery · 57d
Cleared Mar 15, 2023
ECHELON LINEAR™ 60 mm Cutter (GLC60)
K223760 · GDW
Ethicon Endo-Surgery
General & Plastic Surgery · 90d
Cleared Mar 15, 2023
iExaminer System with Panoptic Plus
K223381 · HKI
Welch Allyn, Inc.
Ophthalmic · 128d
Cleared Mar 15, 2023
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low...
K223375 · LZA
Kossan International Sdn Bhd3
General Hospital · 131d
Cleared Mar 15, 2023
Tegamen Nitrile Examination Gloves
K223102 · LZA
M/S Tegamen Safety Products Private...
General Hospital · 166d
Cleared Mar 15, 2023
Air Compression Leg Massager (model: EMK-701)
K222991 · IRP
Xiamen Emoka Health Science &...
Physical Medicine · 168d
Cleared Mar 15, 2023
NeuroBlate Fusion-S Software V3.17
K222983 · GEX
Monteris Medical,
Neurology · 168d
Cleared Mar 15, 2023
Digital Routines
K221924 · NDC
Gnc Holdings, LLC
Chemistry · 257d
Cleared Mar 15, 2023
Precice Intramedullary Limb Lengthening System
K220234 · HSB
Nuvasive Specialized Orthopedics, Inc.
Orthopedic · 412d
Cleared Mar 15, 2023
APEX 6
K220122 · GXD
Rf Innovations, Inc.
Neurology · 421d
Cleared Mar 15, 2023
Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System
K214001 · PHX
Biomet Manufacturing Corp
Orthopedic · 449d
Cleared Mar 14, 2023
ONE-CUF
K230145 · DXQ
Ge Medical Systems Information...
Cardiovascular · 55d
Cleared Mar 14, 2023
SofWave System
K230019 · OHV
Sofwave Medical, Ltd.
General & Plastic Surgery · 70d
Cleared Mar 14, 2023
Cervical Plate System
K223753 · KWQ
Double Medical Technology, Inc.
Orthopedic · 90d
Cleared Mar 14, 2023
RevCore™ Thrombectomy Catheter.
K223609 · QEW
Inari Medical, Inc.
Cardiovascular · 102d