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
12865–12888 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 29, 2022
Kerecis Silicone
K213231 · KGN
Kerecis Limited
General & Plastic Surgery · 272d
Cleared Jun 29, 2022
Eko Murmur Analysis Software (EMAS)
K213794 · DQD
Eko Devices, Inc.
Cardiovascular · 205d
Cleared Jun 29, 2022
Coloring Liquid
K220017 · EIH
Dongguan Xiangtong Co., Ltd.
Dental · 175d
Cleared Jun 29, 2022
FridaMom Anti-Nausea Bands
K220289 · MVV
Fridababy, LLC
Neurology · 148d
Cleared Jun 29, 2022
ARTIS pheno (VE21) System
K220409 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 135d
Cleared Jun 29, 2022
Ebony HP PTA OTW 0.035 Catheter
K220410 · LIT
Natec Medical , Ltd.
Cardiovascular · 135d
Cleared Jun 29, 2022
ARTIS icono (VE21) System
K220432 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 134d
Cleared Jun 29, 2022
DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model...
K220544 · PDU
Ra Medical Systems,Inc
Cardiovascular · 124d
Cleared Jun 29, 2022
Powder Free Nitrile Examination Glove
K220834 · LZA
Daxwell, LLC
General Hospital · 99d
Cleared Jun 29, 2022
RADIFOCUS Torque Device
K220934 · MOF
Terumo Medical Products Hangzhou Co.,...
Neurology · 90d
Cleared Jun 29, 2022
Arthrex Mini Fragment System
K220937 · HRS
Arthrex, Inc.
Orthopedic · 90d
Cleared Jun 29, 2022
BruxZir Opaque Coloring Liquid
K220960 · EIH
Prismatik Dentalcraft, Inc.
Dental · 89d
Cleared Jun 29, 2022
V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System
K220975 · IYN
Samsung Medison Co., Ltd.
Radiology · 86d
Cleared Jun 29, 2022
CLAROX
K221286 · EHD
Vsi Co., Ltd.
Radiology · 57d
Cleared Jun 29, 2022
Diode Laser Hair Removal Device
K221312 · GEX
Guangzhou Chuang Zao Mei Technology...
General & Plastic Surgery · 55d
Cleared Jun 29, 2022
780 nm L11 LED Light Source with AIM
K221611 · OWN
Stryker
General & Plastic Surgery · 26d
Cleared Jun 29, 2022
Flat Panel Detector
K221714 · MQB
Iray Technology Taicang , Ltd.
Radiology · 16d
Cleared Jun 28, 2022
Patient Specific Marking Guides
K211076 · PBF
Additive Orthopaedics, LLC
Orthopedic · 442d
Cleared Jun 28, 2022
3M Attest Rapid Readout Biological Indicator, 1295
K211705 · FRC
3M Company
General Hospital · 390d
Cleared Jun 28, 2022
Venus Cervical Plate System
K211718 · KWQ
Artfx Medical, LLC
Orthopedic · 389d
Cleared Jun 28, 2022
BD Pen Needle
K213478 · FMI
Becton, Dickinson and Company
General Hospital · 242d
Cleared Jun 28, 2022
VenAir, Sequential Compression System
K213577 · JOW
Apex Medical Corp.
Cardiovascular · 230d
Cleared Jun 28, 2022
PL-1 Skin Treatment System
K213726 · GEX
Avava, Inc.
General & Plastic Surgery · 214d
Cleared Jun 28, 2022
Med-link Disposable ECG Cable and Leadwires
K220447 · DSA
Shenzhen Med-Link Electronics Tech...
Cardiovascular · 132d