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
17233–17256 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 01, 2021
Recon Support Catheter
K203275 · DQY
C.R. Bard, Inc.
Cardiovascular · 115d
Cleared Mar 01, 2021
Solitaire X Revascularization Device
K203358 · POL
Micro Therapeutics, Inc. d/b/a ev3...
Neurology · 105d
Cleared Mar 01, 2021
NuVasive Modulus ALIF System
K210271 · OVD
Nu Vasive, Incorporated
Orthopedic · 28d
Cleared Mar 01, 2021
VALO Grand Corded and Accessory Lenses
K210550 · EBZ
Ultradent Products, Inc.
Dental · 4d
Cleared Feb 28, 2021
QardioCore
K201644 · DSH
Qardio, Inc.
Cardiovascular · 256d
Cleared Feb 26, 2021
Archworx
K173738 · NXC
Utah Medical Products and Services
Dental · 1178d
Cleared Feb 26, 2021
ASI Plethysmogrpah Analyzer
K200567 · JOM
Arterial Stiffness, Inc.
Cardiovascular · 359d
Cleared Feb 26, 2021
AsoAligner
K201104 · NXC
Aso International Manila, Inc.
Dental · 308d
Cleared Feb 26, 2021
Bladder Scanner (Model: M3, M3-HD, M4, M4-HD)
K201316 · IYO
Suzhou Peaksonic Medical Technology...
Radiology · 284d
Cleared Feb 26, 2021
Ultrafast, Ultrafast Plus, Ultrafast Lite
K201387 · NVK
Dentlight, Inc.
Dental · 275d
Cleared Feb 26, 2021
SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound System
K201967 · IYN
CHISON Medical Technologies Co., Ltd.
Radiology · 226d
Cleared Feb 26, 2021
SonoEye P3/ SonoEye V3/ Sono Eye G3 Digital Color Doppler Palm Ultrasound System
K201968 · IYN
CHISON Medical Technologies Co., Ltd.
Radiology · 226d
Cleared Feb 26, 2021
imani i1
K202045 · HGX
Imani Co.
Obstetrics & Gynecology · 218d
Cleared Feb 26, 2021
Medical infrared forehead thermometer
K202111 · FLL
Hunan Honggao Electronic Technolofy...
General Hospital · 211d
Cleared Feb 26, 2021
Brite Tip Radianz Guiding Sheath
K202167 · DYB
Cordis Corporation
Cardiovascular · 207d
Cleared Feb 26, 2021
Solax Electric Scooter (Model: S202261B)
K202549 · INI
Dongguan Prestige Sporting Goods Co.,...
Physical Medicine · 176d
Cleared Feb 26, 2021
FLARE Single-Use Surgical Laser Fiber
K202702 · GEX
Realton (Suzhou) Medical Technology...
General & Plastic Surgery · 163d
Cleared Feb 26, 2021
Erisma LP Navigated Instruments
K202956 · OLO
Clariance, Sas
Orthopedic · 149d
Cleared Feb 26, 2021
Spectral CT
K203020 · JAK
Philips Medical Systems Nederland B.V.
Radiology · 147d
Cleared Feb 26, 2021
SubtleMR
K203182 · LLZ
Subtle Medical, Inc.
Radiology · 122d
Cleared Feb 26, 2021
Disposable Vinyl Examination Gloves
K203439 · LYZ
Shandong Zhushi Pharmaceutical Group...
General Hospital · 95d
Cleared Feb 26, 2021
IPL Hair removal
K203510 · OHT
Shenzhen Weikai Technology Co.,Ltd
General & Plastic Surgery · 88d
Cleared Feb 26, 2021
Cuptimize
K203651 · LLZ
Cuptimize, Inc.
Radiology · 74d
Cleared Feb 26, 2021
T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF...
K203819 · HSB
Stryker GmbH
Orthopedic · 59d