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: 2023–2023 ×
3,347 results
3217–3240 of 3,347
Search insights Median review: 139d Cleared: 99% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Orthopedic
Cleared Jan 20, 2023
The Sensititre YeastOne Susceptibility System with Caspofungin in the...
K221899 · NGZ
Thermo Fisher Scientific
Microbiology · 204d
Cleared Jan 20, 2023
Advanced MyHip Planner
K221725 · LLZ
Medacta International S.A.
Radiology · 220d
Cleared Jan 20, 2023
CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS...
K221683 · FAJ
Olympus Medical Systems Corporation
Gastroenterology & Urology · 224d
Cleared Jan 20, 2023
TD-5010 Lancing Device and TD-5084 Sterile Lancets
K221419 · QRL
Gostar Co., Ltd.
General & Plastic Surgery · 249d
Cleared Jan 20, 2023
Digital Thermometer, Model: DT007, DT008
K214077 · FLL
Guangzhou Berrcom Medical Device Co.,...
General Hospital · 389d
Cleared Jan 20, 2023
Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle
K203792 · FMI
Pikdare Spa
General Hospital · 753d
Cleared Jan 19, 2023
Low Profile Companion Sheath
K223872 · DYB
Merit Medical Systems, Inc.
Cardiovascular · 27d
Cleared Jan 19, 2023
AvalancheLase Family
K223540 · GEX
Fotona D.O.O.
General & Plastic Surgery · 55d
Cleared Jan 19, 2023
Access 25(OH) Vitamin D Total
K223503 · MRG
Beckman Coulter, Inc.
Chemistry · 58d
Cleared Jan 19, 2023
Disposable Nitrile Examination Glove
K223250 · LZA
Yangzhou Saraguard Medical Supplies...
General Hospital · 90d
Cleared Jan 19, 2023
Medaica M1 Telehealth Stethoscope
K223166 · DQD
Medaica, Inc.
Cardiovascular · 104d
Cleared Jan 19, 2023
TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN...
K223108 · OLO
Medos International SARL
Orthopedic · 111d
Cleared Jan 19, 2023
EL CAPITAN Anterior Lumbar Interbody Fusion
K222554 · OVD
Astura Medical
Orthopedic · 149d
Cleared Jan 19, 2023
Self-adhesive Electrode
K222252 · GXY
Shenzhen Roundwhale Technology Co. ,...
Neurology · 176d
Cleared Jan 19, 2023
PerfusionGo Plus
K221627 · LLZ
Yukun (Beijing) Technology Co., Ltd.
Radiology · 227d
Cleared Jan 19, 2023
HF-cables (resusable)
K221522 · GEI
Olympus Winter & Ibe GmbH
Gastroenterology & Urology · 238d
Cleared Jan 19, 2023
Tunnel Crossing Catheter
K221163 · PDU
Tractus Vascular, LLC
Cardiovascular · 272d
Cleared Jan 19, 2023
Disposable Non-invasive EEG Sensor
K220448 · GXY
Shenzhen Med-Link Electronics Tech...
Neurology · 337d
Cleared Jan 19, 2023
Biosci™ Inactivated Transport Medium, Biosci™ ITM
K220059 · QBD
Shenzhen Dakewe Bio-Engineering Co.,...
Microbiology · 374d
Cleared Jan 19, 2023
LM-9300 Plus Lithotripter
K213772 · LNS
Lite-Med, Inc.
Gastroenterology & Urology · 413d
Cleared Jan 19, 2023
No Stress Impress
K213175 · ELW
No Stress Impress, LLC
Dental · 478d
Cleared Jan 19, 2023
Disposable Endoscopic Cutter Stapler and Cartridge
K211197 · GDW
Changzhou Waston Medical Appliance...
General & Plastic Surgery · 638d
Cleared Jan 18, 2023
SI-Cure Sacroiliac Joint Fusion System
K223819 · OUR
Alevio, LLC
Orthopedic · 28d
Cleared Jan 18, 2023
PercuNav Image Fusion and Interventional Navigation System
K223804 · JAK
Philips Ultrasound, LLC
Radiology · 30d