FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
10609–10632 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 16, 2023
iSyncBrain©-C
K222838 · OLU
iMediSync, Inc.
Neurology · 177d
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
MilkMate Breast Pump
K223084 · HGX
Milkmate Products, Inc.
Obstetrics & Gynecology · 167d
Cleared Mar 16, 2023
Senhance Surgical System
K223095 · NAY
Asensus Surgical, Inc.
General & Plastic Surgery · 167d
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
Electric Wheelchair
K223393 · ITI
Shanghai Bangbang Robotics Co., Ltd.
Physical Medicine · 128d
Cleared Mar 16, 2023
BENCOX Delta Option Heads
K223828 · LZO
Corentec Co., Ltd.
Orthopedic · 85d
Cleared Mar 16, 2023
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel
K230404 · PCH
Biofire Diagnostics, LLC
Microbiology · 29d
Cleared Mar 15, 2023
Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System
K214001 · PHX
Biomet Manufacturing Corp
Orthopedic · 449d
Cleared Mar 15, 2023
APEX 6
K220122 · GXD
Rf Innovations, Inc.
Neurology · 421d
Cleared Mar 15, 2023
Precice Intramedullary Limb Lengthening System
K220234 · HSB
Nuvasive Specialized Orthopedics, Inc.
Orthopedic · 412d
Cleared Mar 15, 2023
Digital Routines
K221924 · NDC
Gnc Holdings, LLC
Chemistry · 257d
Cleared Mar 15, 2023
NeuroBlate Fusion-S Software V3.17
K222983 · GEX
Monteris Medical,
Neurology · 168d
Cleared Mar 15, 2023
Air Compression Leg Massager (model: EMK-701)
K222991 · IRP
Xiamen Emoka Health Science &...
Physical Medicine · 168d
Cleared Mar 15, 2023
Tegamen Nitrile Examination Gloves
K223102 · LZA
M/S Tegamen Safety Products Private...
General Hospital · 166d
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
iExaminer System with Panoptic Plus
K223381 · HKI
Welch Allyn, Inc.
Ophthalmic · 128d
Cleared Mar 15, 2023
ECHELON LINEAR™ 60 mm Cutter (GLC60)
K223760 · GDW
Ethicon Endo-Surgery
General & Plastic Surgery · 90d
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 14, 2023
HeartBuds Electronic Stethoscope
K212906 · DQD
Heartbuds, LLC
Cardiovascular · 547d
Cleared Mar 14, 2023
JETT PLASMA Medical II
K213247 · QVJ
Compex, Spol, S.R.O.
General & Plastic Surgery · 530d
Cleared Mar 14, 2023
Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application
K223137 · QUH
Hearx SA (Pty) , Ltd.
Ear, Nose, Throat · 161d
Cleared Mar 14, 2023
RT Elements (4.0)
K223279 · MUJ
Brainlab AG
Radiology · 141d
Cleared Mar 14, 2023
Leg and Foot Air Wave Pressure Therapy Device
K223464 · IRP
Zhangzhou Easepal Innovation CO , Ltd.
Physical Medicine · 117d