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
25105–25128 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 12, 2018
White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim
K180452 · LZA
Riverstone Resources Sdn Bhd
General Hospital · 112d
Cleared Jun 12, 2018
SyMRI
K181093 · LNH
Syntheticmr AB
Radiology · 48d
Cleared Jun 12, 2018
HeartSee Cardiac P.E.T. Processing Software
K181343 · KPS
Bracco Diagnostics, Inc.
Radiology · 22d
Cleared Jun 11, 2018
Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color
K171422 · LZA
Ever Global (Vietnam) Enterprise Corp
General Hospital · 392d
Cleared Jun 11, 2018
Ti-one 101 TS Dental Implant System
K172821 · DZE
Hung Chun Bio-S Co., Ltd.
Dental · 266d
Cleared Jun 11, 2018
GRI-Alleset Veress Needle
K172835 · HIF
Gri Medical and Electronic Technology...
Obstetrics & Gynecology · 265d
Cleared Jun 11, 2018
LIAC HWL
K172961 · IYE
Sit Sordina Iort Technologies Spa
Radiology · 258d
Cleared Jun 11, 2018
SOFIA Plus Aspiration Catheter
K173200 · NRY
MicroVention, Inc.
Neurology · 252d
Cleared Jun 11, 2018
Pollogen Legend System
K173503 · GEI
Pollogen, Ltd.
General & Plastic Surgery · 210d
Cleared Jun 11, 2018
X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage...
K173787 · MQP
Medos International SARL
General & Plastic Surgery · 179d
Cleared Jun 11, 2018
Omnican fine
K173803 · FMI
B.Braun Medical, Inc.
General Hospital · 178d
Cleared Jun 11, 2018
BeautiCem Veneer Kit
K180649 · EBF
Shofu Dental Corporation
Dental · 90d
Cleared Jun 11, 2018
CAPERE Thrombectomy System
K180722 · QEW
Kp Medcure, Inc.
Cardiovascular · 84d
Cleared Jun 11, 2018
Endiscope, Endiscope Cervical
K180766 · HRX
Elliquence, LLC
Orthopedic · 80d
Cleared Jun 11, 2018
Vinyl Examination Glove (Clear, Non-Colored)
K180849 · LYZ
Huifu Trading Co., Ltd.
General Hospital · 70d
Cleared Jun 11, 2018
Phenom 27 Catheter
K180959 · DQY
Cathera, Inc.
Cardiovascular · 60d
Cleared Jun 11, 2018
Altus Spine Pedicle Screw System
K181281 · NKB
Altus Partners, LLC
Orthopedic · 27d
Cleared Jun 08, 2018
VT Dressing Kits
K172725 · OMP
Carilex Medical, Inc.
General & Plastic Surgery · 270d
Cleared Jun 08, 2018
Reusable SpO2 Sensors, Disposable SpO2 Sensors
K172981 · DQA
APK Technology Co., Ltd.
Anesthesiology · 254d
Cleared Jun 08, 2018
HSW Resection Instruments
K173070 · HIH
Henke-Sass, Wolf GmbH
Obstetrics & Gynecology · 252d
Cleared Jun 08, 2018
Integrated CardioRespiratory System
K173156 · MWJ
Sensydia, Inc.
Cardiovascular · 252d
Cleared Jun 08, 2018
Lumfuse TP
K173189 · MAX
Precifit Medical, Ltd.
Orthopedic · 249d
Cleared Jun 08, 2018
Piccolo Implants and Accessories
K173706 · DZE
Southern Implants (Pty), Ltd.
Dental · 186d
Cleared Jun 08, 2018
Nexy
K180306 · HKI
Next Sight Srl
Ophthalmic · 126d