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
1753–1776 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 18, 2025
FX CorAL 40
K253518 · KDI
Fresenius Medical Care Renal...
Gastroenterology & Urology · 36d
Cleared Dec 18, 2025
Assert-IQ (DM5100)
K253516 · MXD
Abbott Medical
Cardiovascular · 36d
Cleared Dec 18, 2025
Park Dental Nylon MAD
K252976 · LRK
Park Dental Research Corp.
Dental · 92d
Cleared Dec 18, 2025
Helo Thrombectomy System
K252956 · QEW
Endovascular Engineering, Inc.
Cardiovascular · 93d
Cleared Dec 18, 2025
ARMI® Endoscopic Video Image Processor (JY-MIP-3000)
K252793 · HIH
Jiangsu Jiyuan Medical Technology...
Obstetrics & Gynecology · 111d
Cleared Dec 18, 2025
HemoSphere Alta Advanced Monitoring Platform (ALTAALL1
K252533 · DQK
Edwards Lifesciences
Cardiovascular · 128d
Cleared Dec 18, 2025
Midline Catheter
K252402 · PND
Terumo Medical Products Hangzhou Co.,...
General Hospital · 140d
Cleared Dec 18, 2025
Tomey Optical Biometer OA-2000 (OA-2000)
K252348 · MXK
Tomey Corporation
Ophthalmic · 142d
Cleared Dec 18, 2025
SIMDA Abutments
K252320 · NHA
Simda Co., Ltd.
Dental · 146d
Cleared Dec 18, 2025
PVAD IQ Software
K252235 · QIH
Ultrasight , Ltd.
Radiology · 154d
Cleared Dec 18, 2025
RefleXion Medical Radiotherapy System, Reflexion X2
K252071 · QVA
Reflexion Medical, Inc.
Radiology · 170d
Cleared Dec 18, 2025
Amethyst HP PTA OTW 0.035 Catheter
K251915 · LIT
Natec Medical , Ltd.
Cardiovascular · 178d
Cleared Dec 18, 2025
OTSCneo System Set (100.03n-14n, 100.27n-31n)
K251562 · PKL
Ovesco Endoscopy AG
Gastroenterology & Urology · 210d
Cleared Dec 18, 2025
Single Use Cytology Brush V (BC-V600P-3010)
K250993 · FDX
Olympus Medical Systems Corporation
Gastroenterology & Urology · 262d
Cleared Dec 18, 2025
MediAI-BA
K250914 · QIH
Crescom Co., Ltd.
Radiology · 266d
Cleared Dec 17, 2025
Elecsys Anti-SARS-CoV-2
K253839 · QVP
Roche Diagnostics
Microbiology · 16d
Cleared Dec 17, 2025
KHEIRON® Spinal Fixation System, including patient specific K-ROD
K253721 · NKB
S.M.A.I.O
Orthopedic · 23d
Cleared Dec 17, 2025
Unscented Menstrual Long Applicator Tampon
K253719 · HEB
Unibeauty (Hubei) Technology Co., Ltd.
Obstetrics & Gynecology · 23d
Cleared Dec 17, 2025
Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day...
K253710 · QBJ
Dexcom, Inc.
Chemistry · 23d
Cleared Dec 17, 2025
Vital™ Spinal Fixation System
K253093 · NKB
Highridge Medical, LLC
Orthopedic · 85d
Cleared Dec 17, 2025
Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03)
K252983 · OHS
Shenzhen Goodwind Technology...
General & Plastic Surgery · 90d
Cleared Dec 17, 2025
Neosoma Brain Mets
K252922 · QIH
Neosoma, Inc.
Radiology · 93d
Cleared Dec 17, 2025
ETHICON™ 4000 45mm Compact Stapler (EC3DT45C)
K252739 · GDW
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 111d
Cleared Dec 17, 2025
DuoprossTM Smart Cap (Type I)
K252518 · FMF
Duopross Meditech Corporate
General Hospital · 128d