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

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175,820 results
745–768 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
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
Cleared Jul 15, 2026
Better Diagnostics Dental Assist (BDDA) Version 1.0
K260851 · MYN
Better Diagnostics AI Corp.
Radiology · 121d
Cleared Jul 15, 2026
Profoject™ Pen Needles (Model A
K260739 · FMI
CMT Health PTE., Ltd.
General Hospital · 131d
Cleared Jul 15, 2026
ThinkSono Guidance
K260338 · QJU
ThinkSono GmbH
Radiology · 163d
Cleared Jul 15, 2026
SkeletonPlanner
K260206 · QIH
UPlanner B.V. - Presurgeo
Radiology · 173d
Cleared Jul 15, 2026
WRAP System
K260050 · MNR
Huneo, LLC
Neurology · 189d
Cleared Jul 15, 2026
NanoZoomer S20MD Slide scanner system
K253606 · PSY
Hamamatsu Photonics K.K.
Pathology · 239d
Cleared Jul 15, 2026
Atlas Spine HiRISE™ Expandable Cervical-p Corpectomy Implant
K252822 · PLR
Atlas Spine, Inc.
Orthopedic · 314d
Cleared Jul 14, 2026
VisuBreath
K261633 · CCK
Affirm Medical Technologies II, LLC
Anesthesiology · 57d