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
3385–3408 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 13, 2025
Aventus Thrombectomy System
K251189 · QEW
Inquis Medical
Cardiovascular · 57d
Cleared Jun 13, 2025
Mfinity Femoral System
K251166 · MEH
Medacta International S.A.
Orthopedic · 59d
Cleared Jun 13, 2025
3 in 1 TENS UNIT
K250759 · NGX
Changsha Anxiang Medical Technology...
Physical Medicine · 92d
Cleared Jun 13, 2025
Vessel Sealer Curved (480522)
K250674 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 99d
Cleared Jun 13, 2025
Accuro® 3S Needle Guide Kit
K250469 · ITX
Rivanna Medical, Inc.
Radiology · 115d
Cleared Jun 13, 2025
BinaxNOW COVID-19 Ag Card
K250273 · QVF
Abbott Diagnostics Scarborough, Inc.
Microbiology · 134d
Cleared Jun 13, 2025
Eleganz Fusion Screw System (Fusion Screw System)
K250251 · HWC
Dev4
Orthopedic · 136d
Cleared Jun 13, 2025
Medtronic Stedi Extra Support Guidewire
K250075 · DQX
Medtronic, Inc.
Cardiovascular · 154d
Cleared Jun 13, 2025
FUJIFILM Endoscope Model EB-710P
K244017 · EOQ
Fujifilm Corporation
Ear, Nose, Throat · 168d
Cleared Jun 13, 2025
Prismira
K243729 · QFT
Lumos Labs, Inc.
Neurology · 192d
Cleared Jun 13, 2025
MV Flow Aspiration Pump (MVFLOWPMP01)
K243638 · JCX
Microvention
General & Plastic Surgery · 200d
Cleared Jun 13, 2025
Brainlab Elements (7.0)
K243633 · QIH
Brainlab AG
Radiology · 200d
Cleared Jun 13, 2025
2008T HD SYS. CDX BLUESTAR (191124)
K243237 · KDI
Fresenius Medical Care Renal...
Gastroenterology & Urology · 246d
Cleared Jun 13, 2025
ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845),...
K242852 · ETN
Inomed Medizintechnik GmbH
Ear, Nose, Throat · 266d
Cleared Jun 12, 2025
Bard® Mesh
K251557 · FTL
Davol, Inc.
General & Plastic Surgery · 22d
Cleared Jun 12, 2025
OneLIF™ Interbody Fusion System
K251459 · OVD
Novapproach Spine, LLC
Orthopedic · 31d
Cleared Jun 12, 2025
Disposable Cytology Brush BC-202D/203D Series
K251279 · BTG
Olympus Medical Systems Corporation
Anesthesiology · 49d
Cleared Jun 12, 2025
Medical Monitor (32HS710S)
K251209 · GCJ
Lg Electronics.Inc
General & Plastic Surgery · 55d
Cleared Jun 12, 2025
Grafton™ DBM
K251193 · MQV
Medtronic Sofamor Danek, Inc.
Orthopedic · 56d
Cleared Jun 12, 2025
RIVA Posterior Fixation System
K251154 · NKB
Ht Medical D.B.A. Xenix Medical
Orthopedic · 59d
Cleared Jun 12, 2025
Aurora
K251153 · KPS
Ge Medical Systems Israel
Radiology · 59d
Cleared Jun 12, 2025
Q-Switched Nd:YAG Laser (SHE-LSP101-1)
K250936 · GEX
Beijing Sano Laser S&T Development...
General & Plastic Surgery · 76d
Cleared Jun 12, 2025
ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL)
K250856 · JWY
Biom?rieux
Microbiology · 83d
Cleared Jun 12, 2025
Multi M Series
K250826 · EIH
Dmax Co., Ltd.
Dental · 86d