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
3169–3192 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 03, 2025
Denudation Pipettes
K250838 · MQH
Guangzhou Pinzhi Medical Device Co.,...
Obstetrics & Gynecology · 105d
Cleared Jul 03, 2025
SOMATOM go.Now
K250822 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 107d
Cleared Jul 03, 2025
3DOSE 1ml Syringe
K250733 · FMF
Bimed Teknik Aletler Sanayi & Ticaret...
General Hospital · 114d
Cleared Jul 03, 2025
Disposable Percutaneous Nephrostomy Dilatation Kit
K250448 · LJE
Shenzhen Trious Medical Technology...
Gastroenterology & Urology · 135d
Cleared Jul 03, 2025
Innovita Flu A/B Antigen Rapid Test
K250398 · PSZ
Innovita (Tangshan) Biological...
Microbiology · 141d
Cleared Jul 03, 2025
Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim...
K250286 · QPL
The Magstim Company Limited
Physical Medicine · 153d
Cleared Jul 03, 2025
Pastelle
K250165 · GEX
Wontech Co., Ltd.
General & Plastic Surgery · 163d
Cleared Jul 03, 2025
Boomerang Valvulotome (BMGVT080)
K250105 · MGZ
Aveera Medical, Inc.
Cardiovascular · 169d
Cleared Jul 03, 2025
SMR Reverse HP Shoulder System
K243826 · PHX
Lima Corporate S.P.A.
Orthopedic · 203d
Cleared Jul 03, 2025
MammoScreen® (4)
K243679 · QDQ
Therapixel
Radiology · 216d
Cleared Jul 03, 2025
TalisMann Neuromodulation System
K243678 · GZF
Bioventus, LLC
Neurology · 218d
Cleared Jul 03, 2025
Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed...
K243280 · ERL
W&H Dentalwerk Buermoos GmbH
Ear, Nose, Throat · 259d
Cleared Jul 03, 2025
URIS Long Implant & Abutments
K243255 · DZE
Truabutment, Inc.
Dental · 261d
Cleared Jul 03, 2025
Onera STS 2 (ONERA STS 2)
K243220 · MNR
Onera B.V.
Neurology · 269d
Cleared Jul 03, 2025
BD Vacutainer® Eclipse™ Blood Collection Needle
K243207 · JKA
Becton, Dickinson and Company
General Hospital · 275d
Cleared Jul 03, 2025
IPL Treatment Device (MDSQMC-01)
K243123 · ONF
Medusa (Guangxi)Medical Devices Co.,...
General & Plastic Surgery · 276d
Cleared Jul 02, 2025
Pure Impact
K251746 · NGX
Sofwave Medical, Ltd.
Neurology · 26d
Cleared Jul 02, 2025
OsteoFlo HydroFiber
K251720 · MQV
SurGenTec, LLC
Orthopedic · 28d
Cleared Jul 02, 2025
8 mm Assist Cannula
K251490 · GCJ
Intuitive Surgical, Inc.
General & Plastic Surgery · 49d
Cleared Jul 02, 2025
Electric Wheelchair (HG-630)
K251285 · ITI
Zhejiang Automwheel Tech Co., Ltd.
Physical Medicine · 68d
Cleared Jul 02, 2025
EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones)
K251241 · JWH
Encore Medical, L.P.
Orthopedic · 71d
Cleared Jul 02, 2025
SurgiLight 1470 Diode Laser System (Model:Halo)
K251049 · GEX
Micro-Energy Medical Technology Co.,...
General & Plastic Surgery · 90d
Cleared Jul 02, 2025
Fiber Laser Treatment Systems (HS-232,HS-233)
K251031 · ONG
Shanghai Apolo Medical Technology...
General & Plastic Surgery · 90d
Cleared Jul 02, 2025
Identity Shoulder System
K250848 · MBF
Zimmer, Inc.
Orthopedic · 104d