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
1921–1944 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 28, 2025
Sophy Mini Monopressure Valve (SM1)
K250636 · JXG
Sophysa
Neurology · 270d
Cleared Nov 27, 2025
Carriere® Motion Pro® Clear Bite Corrector
K252760 · DYW
Ortho Organizers, Inc.
Dental · 90d
Cleared Nov 26, 2025
OEC One CFD
K253269 · OXO
Ge Hualun Medical Systems Co. , Ltd.
Radiology · 58d
Cleared Nov 26, 2025
0.014” Willow Guidewire
K253168 · MOF
Arbor Endovascular, LLC
Neurology · 61d
Cleared Nov 26, 2025
Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional...
K252405 · NLH
Surgical Instrument Service and...
Cardiovascular · 118d
Cleared Nov 26, 2025
Vanquish Water Vapor Ablation Device
K252388 · KNS
Francis Medical, Inc.
Gastroenterology & Urology · 118d
Cleared Nov 26, 2025
K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing
K252355 · PTI
Sb-Kawasumi Laboratories, Inc.
General Hospital · 120d
Cleared Nov 26, 2025
RELIEEV HSG Catheter (HSG7FA1)
K252260 · LKF
Li Medical Corporation , Ltd.
Obstetrics & Gynecology · 128d
Cleared Nov 26, 2025
CEREC Tessera Abutment System
K252248 · NHA
Dentsply Sirona
Dental · 131d
Cleared Nov 26, 2025
uDR Arria & uDR Aris
K252000 · KPR
Shanghai United Imaging Healthcare...
Radiology · 152d
Cleared Nov 26, 2025
Flowflex® Plus Strep A Rapid Test Cassette
K251697 · GTY
ACON Laboratories, Inc.
Microbiology · 177d
Cleared Nov 26, 2025
Fenom Flo™ FeNO Monitoring System
K251674 · MXA
Mgc Diagnostics Corporation
Chemistry · 180d
Cleared Nov 26, 2025
Tru Kidney Health Test Panel
K251058 · CGX
Truvian Health
Chemistry · 236d
Cleared Nov 26, 2025
Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport...
K242976 · JSM
Medical Wire & Equipment Company...
Microbiology · 426d
Cleared Nov 25, 2025
LuxCreo Flexible Partial Denture Resin
K253365 · EBI
LuxCreo, Inc.
Dental · 56d
Cleared Nov 25, 2025
BELLUS-Q
K253344 · GEX
Speclipse, Inc.
General & Plastic Surgery · 56d
Cleared Nov 25, 2025
7600 Ultrasound System (MyLabC25)
K253310 · IYN
Esaote, S.P.A.
Radiology · 57d
Cleared Nov 25, 2025
IPL Hair Removal Device (KA-10, KA-11, KA-11C, KA-11D, KA-18, KA-20, KA-21,...
K253304 · OHT
Dongguan Lide Electric Appliance Co.,...
General & Plastic Surgery · 57d
Cleared Nov 25, 2025
LeafPure-Echo (LM-LPNdA)
K253219 · GEX
Shenzhen Leaflife Technology Co., Ltd.
General & Plastic Surgery · 57d
Cleared Nov 25, 2025
Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)
K252889 · KNS
Olympus Medical Systems Corporation
Gastroenterology & Urology · 76d
Cleared Nov 25, 2025
HALO AP Dx
K252762 · QKQ
Indica Labs, LLC
Pathology · 88d
Cleared Nov 25, 2025
ZSFab Lumbar Interbody System
K252610 · MAX
Zsfab, Inc.
Orthopedic · 99d
Cleared Nov 25, 2025
Medusa Orthopedics Boa External Fixation System
K252555 · KTT
Medusa Orthopedics, LLC
Orthopedic · 104d
Cleared Nov 25, 2025
Eva Scalp Cooling System
K252289 · PMC
Stemtech Medical Devices Private Limited
General & Plastic Surgery · 125d