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
5977–6000 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 23, 2024
ONE Nitrile Condom
K240896 · MOL
Global Protection Corp.
Obstetrics & Gynecology · 144d
Cleared Aug 23, 2024
Polyisoprene Surgical gloves
K240790 · KGO
Suzhou Colour-Way New Material Co., Ltd.
General Hospital · 154d
Cleared Aug 23, 2024
VEEGix EEG System
K240593 · OLT
Neuroservo, Inc.
Neurology · 175d
Cleared Aug 23, 2024
SITTER 3.5mm Versatile System
K240318 · HRS
Bonebridge AG
Orthopedic · 203d
Cleared Aug 23, 2024
Nova Micro Pillows Mask Small A Model (NVP1SA)
K233829 · BZD
Fisher and Paykel Healthcare Limited
Anesthesiology · 266d
Cleared Aug 23, 2024
Nalu Neurostimulation System for Spinal Cord Stimulation
K233801 · GZB
Boston Scientific Neuromodulation
Neurology · 268d
Cleared Aug 23, 2024
SCoV-2 Ag Detect Rapid Test
K233358 · QVF
InBios International, Inc.
Microbiology · 329d
Cleared Aug 23, 2024
Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap,...
K231100 · DZE
Proimtech Saglik Urunleri Anonim Sirketi
Dental · 493d
Cleared Aug 22, 2024
Introducer Sheath Kits
K242248 · DYB
Beijing Demax Medical Technology Co.,Ltd
Cardiovascular · 22d
Cleared Aug 22, 2024
I.V. Administration Set
K242126 · FPA
Bq Plus Medical Co., Ltd.
General Hospital · 34d
Cleared Aug 22, 2024
Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro)
K241979 · IYN
Beijing Konted Medical Technology...
Radiology · 48d
Cleared Aug 22, 2024
TRIGEN INTERTAN 10S Nail System
K241804 · JDS
Smith & Nephew, Inc.
Orthopedic · 62d
Cleared Aug 22, 2024
INSULCLOCK® v2.0 PRO
K241803 · QOG
Insulcloud S.L.
General Hospital · 62d
Cleared Aug 22, 2024
LIJIA Night Guard
K241369 · MQC
Lijia, LLC
Dental · 100d
Cleared Aug 22, 2024
Single-use Sterile High-pressure Angiographic Syringes and Accessories
K241109 · DXT
Shenzhen Boon Medical Supply Co., Ltd.
General Hospital · 122d
Cleared Aug 22, 2024
NeuroQuant
K241098 · QIH
Cortechs Labs, Inc.
Radiology · 122d
Cleared Aug 22, 2024
LiNA CystoVu™ HD (CYV-100-5
K240227 · FAJ
Lina Medical Aps
Gastroenterology & Urology · 209d
Cleared Aug 22, 2024
Phantom Fibula Nail System
K234128 · HSB
Paragon 28, Inc.
Orthopedic · 238d
Cleared Aug 22, 2024
iCare ALTIUS CW
K234076 · NFJ
Centervue S.P.A.
Ophthalmic · 245d
Cleared Aug 22, 2024
Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking...
K230071 · HSB
Tdm Co., Ltd.
Orthopedic · 590d
Cleared Aug 21, 2024
Fraxel® FTX Laser System
K242142 · GEX
Solta Medical
General & Plastic Surgery · 30d
Cleared Aug 21, 2024
TiLink-P SI Joint Fusion System
K242141 · OUR
SurGenTec, LLC
Orthopedic · 30d
Cleared Aug 21, 2024
iSage Rx
K242066 · NDC
Amalgam Rx, Inc.
Chemistry · 37d
Cleared Aug 21, 2024
Blood Pressure Monitor (TMB-2092-G)
K241351 · DXN
Guangdong Transtek Medical...
Cardiovascular · 100d