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
745–768 of 2,517
Search insights Median review: 135d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Jul 17, 2026
Diode laser hair removal machine (QDTM-04)
K261693 · GEX
Beijing Nubway S&T Co., Ltd.
General & Plastic Surgery · 56d
Cleared Jul 17, 2026
CHZL Red Light Therapy Hair Growth Cap...
K261675 · OAP
Shenzhen Chuanghong Zhilian...
General & Plastic Surgery · 57d
Cleared Jul 17, 2026
LoFric Origo Pro Coudé
K261658 · EZD
Wellspect AB
Gastroenterology & Urology · 59d
Cleared Jul 17, 2026
LED LCD Monitor (OEV-271H)
K261614 · GCJ
Lg Electronics.Inc
General & Plastic Surgery · 63d
Cleared Jul 17, 2026
BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit
K261475 · PMN
Biofire Defense, LLC
Microbiology · 73d
Cleared Jul 17, 2026
Dental Zirconia Blank & Coloring Liquid
K261046 · EIH
Hunan Qinghao Puzhong Technology Co.,...
Dental · 108d
Cleared Jul 17, 2026
ZEISS CLINIC 360
K260694 · NFJ
Carl Zeiss Meditec, AG
Ophthalmic · 136d
Cleared Jul 17, 2026
Drivewire 35 Guidewire
K254006 · MOF
Rapid Medical , Ltd.
Neurology · 214d
Cleared Jul 17, 2026
Cubresa BrainPET
K253963 · OUO
Cubresa, Inc.
Radiology · 218d
Cleared Jul 17, 2026
Natural Cycles
K253694 · PYT
Natural Cycles Nordic AB
Obstetrics & Gynecology · 238d
Cleared Jul 17, 2026
Catalyft PL Expandable Interbody System
K253011 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 301d
Cleared Jul 17, 2026
Virasight
K251952 · PSY
Virasoft Corporation
Pathology · 387d
Not Cleared Jul 17, 2026
SportSuite Vision Software
DEN250040 · SIT
Stryker Endoscopy
Orthopedic · 318d
Cleared Jul 16, 2026
TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD)
K262032 · HRS
TriMed, Inc.
Orthopedic · 29d
Cleared Jul 16, 2026
Endomat Select (UP220)
K261706 · HIG
Karl Storz SE & CO. KG
Obstetrics & Gynecology · 55d
Cleared Jul 16, 2026
Skin Air Cooling System (QALF-01)
K261674 · GEX
Beijing Nubway S&T Co., Ltd.
General & Plastic Surgery · 56d
Cleared Jul 16, 2026
Palisades™ Buttress Plate System
K261309 · KWQ
Bethesda Medical Devices, LLC
Orthopedic · 86d
Cleared Jul 16, 2026
Cable-Ready® Cable Grip System
K261271 · JDQ
Pioneer Surgical Technology, Inc.
Orthopedic · 90d
Cleared Jul 16, 2026
cobas® BV/CV
K260021 · PQA
Roche Molecular Systems, Inc.
Microbiology · 192d
Cleared Jul 16, 2026
Socrates Aspiration System (Socrates 70 Aspiration Catheter)
K260002 · NRY
Scientia Vascular, Inc.
Neurology · 195d
Cleared Jul 15, 2026
Aventus Thrombectomy System
K262030 · QEZ
Inquis Medical
Cardiovascular · 28d
Cleared Jul 15, 2026
EnSite™ X EP System
K262006 · DQK
Abbott Medical
Cardiovascular · 30d
Cleared Jul 15, 2026
XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368,...
K261407 · OHS
Dongguan Miqiang Technology Co., Ltd.
General & Plastic Surgery · 77d
Cleared Jul 15, 2026
Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System
K261353 · OVD
Kyocera Medical Technologies, Inc.
Orthopedic · 82d