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
12889–12912 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 28, 2022
DePuy CONDUIT LLIF SQUID Inserter
K220449 · MAX
Enztec Limited
Orthopedic · 132d
Cleared Jun 28, 2022
Magnum
K220670 · FXX
Magnum Health and Safety Pvt, Ltd.
General Hospital · 113d
Cleared Jun 28, 2022
OsteoProbe
K221195 · QGQ
Active Life Scientific, Inc.
Orthopedic · 64d
Cleared Jun 28, 2022
Mg OSTEOINJECT
K221256 · MQV
Bone Solutions, Inc.
Orthopedic · 57d
Cleared Jun 28, 2022
Medical Face Mask
K221272 · FXX
Shandong Xingyu Gloves Co., Ltd.
General Hospital · 57d
Cleared Jun 28, 2022
Medical Face Mask (M001)
K221273 · FXX
Xingyu Medical Tech Co., Ltd.
General Hospital · 57d
Cleared Jun 27, 2022
Navident
K210947 · PLV
Claronav, Inc.
Dental · 454d
Cleared Jun 27, 2022
CiRX Single use electrosurgical pencil with non-coated and coated electrode
K213786 · GEI
Ningbo Shun YE Medical Company, Ltd.
General & Plastic Surgery · 203d
Cleared Jun 27, 2022
VersaOne Optical Trocar with Fixation Balloon Cannula, VersaOne Universal...
K213818 · GCJ
Covidien
General & Plastic Surgery · 202d
Cleared Jun 27, 2022
Wearable Breast Pump (Model S10)
K220309 · HGX
Shenzhen Lutejiacheng Technology Co.,...
Obstetrics & Gynecology · 145d
Cleared Jun 27, 2022
Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare
K220790 · FDI
Yangzhou Fartley Medical Instrument...
Gastroenterology & Urology · 102d
Cleared Jun 27, 2022
Venue Fit
K220848 · IYN
GE Medical Systems
Radiology · 96d
Cleared Jun 27, 2022
Venue
K220851 · IYN
GE Medical Systems
Radiology · 96d
Cleared Jun 27, 2022
DT-703
K221233 · EHD
Ecotron Co., Ltd.
Radiology · 59d
Cleared Jun 24, 2022
RoughRider Aurora Manual Wheelchair
K200715 · IOR
Roughrider America, LLC
Physical Medicine · 828d
Cleared Jun 24, 2022
Noris Medical Dental Implants System - Cortical
K210852 · DZE
Noris Medical , Ltd.
Dental · 459d
Cleared Jun 24, 2022
TRAUS ENDO
K212043 · EKX
Saeshin Precision Co., Ltd.
Dental · 359d
Cleared Jun 24, 2022
EZYPOR
K212741 · HPZ
Fci (France Chirurgie...
Ophthalmic · 298d
Cleared Jun 24, 2022
BentrioTM Allergy Blocker
K213114 · NUP
Altamira Therapeutics, Inc.
Ear, Nose, Throat · 270d
Cleared Jun 24, 2022
Secret Duo
K213250 · GEX
Ilooda Co,., Ltd.
General & Plastic Surgery · 267d
Cleared Jun 24, 2022
FlexBoardTM, EagleBoardTM, BreastBoard SXTM
K213439 · IYE
Macromedics BV
Radiology · 242d
Cleared Jun 24, 2022
Intelligence LaserComb
K213789 · OAP
Yibin Yingtong Intelligent Technology...
General & Plastic Surgery · 200d
Cleared Jun 24, 2022
T-FIX® 3DSI Joint Fusion System
K214123 · OUR
Cutting Edge Spine, LLC
Orthopedic · 176d
Cleared Jun 24, 2022
OTOPLAN
K220300 · QQE
Cascination AG
Ear, Nose, Throat · 142d