FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: 2026–2026 ×
2,517 results
553–576 of 2,517
Search insights Median review: 135d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Aug 07, 2026
Aperio GT 450 DX
K253554 · PSY
Leica Biosystems Imaging, Inc.
Pathology · 266d
Cleared Aug 07, 2026
Zamenix™ P
K253505 · FGB
Roen Surgical, Inc.
General & Plastic Surgery · 280d
Cleared Aug 07, 2026
Metrix COVID Test
K253453 · QWB
Aptitude Medical Systems, Inc.
Microbiology · 305d
Cleared Aug 07, 2026
mdprostate
K252571 · QIH
Mediaire GmbH
Radiology · 358d
Cleared Aug 07, 2026
Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0)
K251544 · EIA
Lakong Medical Devices Co., Ltd.
Dental · 444d
Cleared Aug 06, 2026
Triathlon® Knee System
K261898 · KRO
Howmedica Osteonics Corp., Dba...
Orthopedic · 62d
Cleared Aug 06, 2026
Manual Wheelchair (H008, PCK7)
K261571 · IOR
Jiangsu Yuyue Medical Equipment&...
Physical Medicine · 86d
Cleared Aug 06, 2026
Megalodon Dynamic Compression System
K261121 · JDR
Paragon 28, Inc.
Orthopedic · 125d
Cleared Aug 06, 2026
Overjet Multi-Image Caries and Charting Assist
K261059 · MYN
Overjet, Inc.
Radiology · 128d
Cleared Aug 06, 2026
Aristotle Mini Guidewire
K260223 · MOF
Scientia Vascular, Inc.
Neurology · 192d
Cleared Aug 06, 2026
QIAstat-Dx BCID GPF Plus AMR Panel
K254194 · PAM
QIAGEN GmbH
Microbiology · 226d
Cleared Aug 06, 2026
Universal Base ASC Engaging
K253999 · NHA
Nobel Biocare AB
Dental · 234d
Cleared Aug 06, 2026
Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM)
K253469 · FIE
Mozarc Medical Us, LLC
Gastroenterology & Urology · 300d
Cleared Aug 06, 2026
Telemetry Monitor (iT30, iT50)
K251508 · MHX
Edan Instruments, Inc.
Cardiovascular · 447d
Cleared Aug 05, 2026
Rusch Latex Gold Foley Catheter
K262056 · EZL
Teleflex Medical Sdn. Bhd.
Gastroenterology & Urology · 48d
Cleared Aug 05, 2026
Leksell® Vantage Stereotactic System
K261932 · HAW
Elekta Solutions AB
Neurology · 57d
Cleared Aug 05, 2026
Ruthinium Disc
K261456 · POW
Dental Manufacturing S.P.A
Dental · 96d
Cleared Aug 05, 2026
Concentriq AP-Dx
K261380 · QKQ
Proscia, Inc.
Pathology · 100d
Cleared Aug 05, 2026
Transurethral Catheter Safety Valve (TUCSV) (80050)
K260919 · KNY
Class Medical , Ltd.
Gastroenterology & Urology · 139d
Cleared Aug 05, 2026
Huahong Sharps Container (HHR-I, HHR-II)
K260845 · MMK
Tianjin Huahong Technology Co., Ltd.
General Hospital · 142d
Cleared Aug 05, 2026
Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16)
K260737 · EZD
Convatec
Gastroenterology & Urology · 152d
Cleared Aug 05, 2026
NaturaJel™ Oral Wound Care Kit
K260120 · OLR
HCS Innovation, LLC
Dental · 202d
Cleared Aug 05, 2026
pVasc Net Mechanical Thrombectomy Device
K254211
Vesalio, Inc.
Cardiovascular · 219d
Cleared Aug 05, 2026
GFS - Sterile Screws and Top Hat
K253858 · HWC
T.A.G. Medical Products Corporation,...
Orthopedic · 245d