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
841–864 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 06, 2026
APERTO Lucent MRI System
K253862 · LNH
Fujifilm Corporation
Radiology · 124d
Cleared Apr 06, 2026
6450 Ultrasound System (MyLabE80)
K253288 · IYN
Esaote, S.P.A.
Radiology · 189d
Cleared Apr 06, 2026
Light-curing Coloring Materials (ALCM)
K253036 · EBF
Aidite (Qinhuangdao) Technology Co.,...
Dental · 196d
Cleared Apr 06, 2026
Ricoh 3D for Healthcare Bolus
K253025 · IXI
Ricoh 3D For Healthcare, LLC
Radiology · 199d
Cleared Apr 06, 2026
in2 Smart (in2S)
K252809 · QRC
Virility Medical , Ltd.
Gastroenterology & Urology · 215d
Cleared Apr 06, 2026
ProSomnus RPMO2 OSA Device (RPMO2 OSA)
K252765 · PLC
Prosomnus Sleep Technologies
Dental · 220d
Cleared Apr 06, 2026
SV70 Ventilator (SV70)
K252182 · MNT
Shenzhen Mindray Bio-Medical...
Anesthesiology · 269d
Cleared Apr 06, 2026
SPECTRA Wearable 2
K250208 · HGX
Uzinmedicare Co., Ltd.
Obstetrics & Gynecology · 437d
Cleared Apr 03, 2026
KHEIRON® Spinal Fixation System, including patient specific K-ROD
K260786 · NKB
S.M.A.I.O
Orthopedic · 24d
Cleared Apr 03, 2026
MAGENTIQ-COLO (ME-APDS)
K260724 · QNP
Magentiq Eye, Ltd.
Gastroenterology & Urology · 29d
Cleared Apr 03, 2026
mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717)
K260720 · ETB
Med-El Elektromedizinische Ger?te GmbH
Ear, Nose, Throat · 29d
Cleared Apr 03, 2026
mGRIP Total Prosthesis (3.00 mm) (58689)
K260719 · ETA
Med-El Elektromedizinische Ger?te GmbH
Ear, Nose, Throat · 29d
Cleared Apr 03, 2026
mGRIP Partial Prosthesis (0.75 mm) (58669)
K260718 · ETB
Med-El Elektromedizinische Ger?te GmbH
Ear, Nose, Throat · 29d
Cleared Apr 03, 2026
uMI Panvivo (uMI Panvivo LS)
K260524 · KPS
Shanghai United Imaging Healthcare...
Radiology · 45d
Cleared Apr 03, 2026
Ceribell Brain Monitor Headband
K260363 · GXY
Ceribell, Inc.
Neurology · 58d
Cleared Apr 03, 2026
Single-use Video Scope
K254153 · FBN
Mirco-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 102d
Cleared Apr 03, 2026
Etiometry Platform
K254066 · PPW
Etiometry, Inc.
Cardiovascular · 106d
Cleared Apr 03, 2026
Life Saving Tourniquet
K254060 · DXC
TW Medical
Cardiovascular · 107d
Cleared Apr 03, 2026
ClearCheck (RADCC V2.7)
K253962 · IYE
Radformation, Inc.
Radiology · 113d
Cleared Apr 03, 2026
Blueprint Patient-Specific Instrumentation
K253674 · PHX
Stryker Corporation (Tornier, S.A.S.)
Orthopedic · 133d
Cleared Apr 03, 2026
Electric Wheelchair (AL-208S-063)
K253340 · ITI
Zhongshan A&J Medical Equipment Co.,...
Physical Medicine · 185d
Cleared Apr 03, 2026
Disposable Stone Extraction Basket
K253056 · LQR
Zhejiang Soudon Medical Technology...
Gastroenterology & Urology · 193d
Cleared Apr 03, 2026
Tyber Medical Trauma Screw
K253042 · HWC
Tyber Medical, LLC
Orthopedic · 193d
Cleared Apr 03, 2026
Wearable Electric Breast Pump (RH 668, RH 708, RH 718, RH 728)
K252744 · HGX
Cixi Ruihong Electric Appliance Co.,...
Obstetrics & Gynecology · 217d