FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
13129–13152 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 30, 2022
Epicardial Access System
K213582 · DYB
Baylis Medical Company, Inc.
Cardiovascular · 230d
Cleared Jun 30, 2022
leva Pelvic Health System
K213913 · HIR
Renovia, Inc.
Gastroenterology & Urology · 197d
Cleared Jun 30, 2022
VASSALLO GT 018 Floppy
K213949 · DQX
Filmecc Co., Ltd.
Cardiovascular · 195d
Cleared Jun 30, 2022
Sparta 3-Ply Surgical Disposable Face Mask
K220378 · FXX
Sparta East, LLC
General Hospital · 140d
Cleared Jun 30, 2022
NC TREK NEO Coronary Dilatation Catheter
K220634 · LOX
Abbott Vascular
Cardiovascular · 118d
Cleared Jun 30, 2022
Wrist Type Blood Pressure Monitor
K220651 · DXN
Shenzhen Jamr Medical Technology Co.,...
Cardiovascular · 115d
Cleared Jun 30, 2022
ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System,...
K221050 · OUR
Aegis Spine, Inc.
Orthopedic · 80d
Cleared Jun 30, 2022
Intense Pulsed Light (IPL) System, model: T013C, T015C, T015K
K221569 · OHT
Shenzhen Fansizhe Science And...
General & Plastic Surgery · 30d
Cleared Jun 30, 2022
InMode Multi-system
K221571 · GEX
Inmode , Ltd.
General & Plastic Surgery · 30d
Cleared Jun 30, 2022
CPS AIM Universal II Slittable Inner Catheter
K221750 · DQY
Abbott Medical
Cardiovascular · 14d
Cleared Jun 29, 2022
Powered Breast Pump (Models 7V and 7X)
K211016 · HGX
Haenim Co., Ltd.
Obstetrics & Gynecology · 450d
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