FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
25705–25728 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jun 08, 2018
17HK700G-W
K180332 · MQB
Lg Electronics
Radiology · 122d
Cleared Jun 08, 2018
Single Use Aspiration Needle NA-U200H
K180449 · FCG
Olympus Medical Systems Corp.
Gastroenterology & Urology · 108d
Cleared CT Jun 08, 2018
Avanti
K180660 · OBO
Optovue, Inc.
Ophthalmic · 86d
Cleared Jun 08, 2018
Sniper Infusion Catheter with Balloon Occlusion
K180904 · MJN
Embolx, Inc.
Cardiovascular · 63d
Cleared Jun 08, 2018
Aveo (omafilcon A) Soft (Hydrophilic) Contact Lenses
K180985 · LPL
Supervision Optimax Sdn Bhd
Ophthalmic · 56d
Cleared Jun 08, 2018
Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens, Acuity 58...
K180988 · HQD
Acuity Polymers, Inc.
Ophthalmic · 53d
Cleared Jun 07, 2018
Digital Thermometer
K172121 · FLL
Fudakang Industrial Co., Ltd.
General Hospital · 329d
Cleared Jun 07, 2018
FOCAL ONE
K172721 · PLP
Edap Technomed, Inc.
Gastroenterology & Urology · 272d
Cleared Jun 07, 2018
ELEVARE, PERFECTIO 4
K172909 · OHS
Omm Imports D/B/A Zero Gravity
General & Plastic Surgery · 255d
Cleared Jun 07, 2018
Paxman Scalp Cooler
K173032 · PMC
Paxman Coolers Limited
General & Plastic Surgery · 252d