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: 2026–2026 ×
1,642 results
793–816 of 1,642
Search insights Median review: 137d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Apr 10, 2026
Relu Cloud
K252708 · QIH
Relu BV
Dental · 226d
Cleared Apr 10, 2026
CoAptix S System
K252699 · HWC
University of Utah, Department of...
Orthopedic · 226d
Cleared Apr 10, 2026
AI-Rad Companion Organs RT
K252548 · QKB
Siemens Healthcare GmbH
Radiology · 240d
Cleared Apr 10, 2026
BD Vacutainer® Safety-Lok™ Blood Collection Set
K252506 · JKA
Becton, Dickinson and Company
General Hospital · 245d
Cleared Apr 10, 2026
ClenchNoMore (CNM-1 (Mixed sizing))
K252485 · OBR
1987 Media Limited
Dental · 246d
Cleared Apr 10, 2026
BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™...
K252378 · JKA
Becton, Dickinson and Company
Chemistry · 254d
Cleared Apr 10, 2026
Vista 300/Vista 300 S
K252250 · MHX
Shanghai Draeger Medical Instrument...
Cardiovascular · 267d
Cleared Apr 10, 2026
Pressio 3 Multi-parameter Neuromonitoring System
K252241 · GWM
Sophysa
Neurology · 267d
Cleared Apr 10, 2026
ABL90 FLEX PLUS System, safeCLINITUBES
K252207 · CHL
Radiometer Medicals Aps
Chemistry · 270d
Cleared Apr 10, 2026
DeepBT Detector-Plus
K252190 · QKB
Aitewan Biomedical Technology, Inc.
Radiology · 270d
Cleared Apr 09, 2026
LOCATOR® Angled Abutment
K260555 · NHA
Zest Anchors, LLC
Dental · 50d
Cleared Apr 09, 2026
RCT800
K260462 · OAS
Ray Co., Ltd.
Radiology · 56d
Cleared Apr 09, 2026
Artelon Convenience Kits
K260317 · QWJ
International Life Sciences
Orthopedic · 69d
Cleared Apr 09, 2026
SILKBridge
K260245 · JXI
KLISBio S.r.l.
Neurology · 72d
Cleared Apr 09, 2026
Eternal Art Porcelain Powders
K260067 · EIH
Shandong Huge Dental Material...
Dental · 90d
Cleared Apr 09, 2026
Picosecond Nd:YAG Laser Systems (Model: HS-298)
K260017 · GEX
Shanghai Apolo Medical Technology...
General & Plastic Surgery · 94d
Cleared Apr 09, 2026
SPINEART Navigation Instrument System
K254158 · OLO
Spineart SA
Orthopedic · 108d
Cleared Apr 09, 2026
Accuro XV
K254021 · IYO
Rivanna Medical, Inc.
Radiology · 114d
Cleared Apr 09, 2026
Radical 6F Access Catheter
K253975 · QJP
Maduro Medical, Inc.
Neurology · 119d
Cleared Apr 09, 2026
Single Use Digital Flexible Ureteroscope (7.5F)
K252929 · FGB
Anhui Happiness Workshop Instruments...
Gastroenterology & Urology · 206d
Cleared Apr 09, 2026
EASYMADE-TI
K252251 · GXN
CG Bio Co., Ltd.
Neurology · 265d
Cleared Apr 09, 2026
Seaman Pro/Seaman
K252228 · POV
Checkcells, Inc.
Hematology · 267d
Cleared Apr 08, 2026
OptiCross Coronary Imaging Catheter (H749518110)
K260816 · OBJ
Boston Scientific
Cardiovascular · 26d
Cleared Apr 08, 2026
Celerity 5 HP Biological Indicator (LCB052)
K260766 · FRC
STERIS Corporation
General Hospital · 30d