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
22009–22032 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 20, 2019
SeeFactorCT3
K190856 · OAS
Epica International, Inc.
Radiology · 171d
Cleared Sep 20, 2019
CivaDerm
K191324 · KXK
Civatech Oncology, Inc.
Radiology · 127d
Cleared Sep 20, 2019
Omnipod DASH Insulin Management System with interoperable technology
K191679 · QFG
Insulet Corporation
Chemistry · 88d
Cleared Sep 20, 2019
Hinged Laminoplasty System
K191927 · NQW
Life Spine, Inc.
Orthopedic · 63d
Cleared Sep 20, 2019
Philips IntelliSite Pathology Solution
K192259 · PSY
Philips Electronics Nederland B.V.
Pathology · 30d
Cleared Sep 20, 2019
Merge Cardio
K192276 · LLZ
Merge Healthcare Incorporated
Radiology · 29d
Cleared Sep 20, 2019
Medtronic 6F Taiga Guiding Catheter
K192296 · DQY
Medtronic Vascular
Cardiovascular · 28d
Cleared Sep 20, 2019
BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip
K192301 · NFW
Shenzhen Bioeasy Biotechnology Co., Ltd.
Toxicology · 28d
Cleared Sep 20, 2019
ClotTriever Thrombectormy System, ClotTriever Catheter, ClotTriever Sheath
K192332 · QEW
Inari Medical
Cardiovascular · 24d
Cleared Sep 20, 2019
syngo.CT Extended Functionality
K192402 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 17d
Cleared Sep 19, 2019
SupaScoota Motorized vehicle - Spartan (Sumo)/ Spartan SP (Sumo SP)
K182631 · INI
Eurogreen International, Inc.
Physical Medicine · 360d
Cleared Sep 19, 2019
High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws
K190526 · PML
CarboFix Orthopedics , Ltd.
Orthopedic · 199d
Cleared Sep 19, 2019
GEHC DXA Bone Densitometers with enCORE version 18
K191112 · KGI
GE Medical Systems Ultrasound &...
Radiology · 146d
Cleared Sep 19, 2019
RS80 EVO Diagnostic Ultrasound System
K192030 · IYN
Samsung Medison Co., Ltd.
Radiology · 51d
Cleared Sep 19, 2019
ProPerformance Recovery System
K192252 · IRP
Menlo Brands, LLC
Physical Medicine · 30d
Cleared Sep 19, 2019
HardyDisk AST Lefamulin 20µg (LMU20)
K192326 · JTN
Hardy Diagnostics
Microbiology · 23d
Cleared Sep 19, 2019
Sapphire NC Plus Coronary Dilatation Catheter
K192344 · LOX
Orbusneich Medical Trading, Inc.
Cardiovascular · 21d
Cleared Sep 18, 2019
VORTRAN APM-Plus
K182292 · CAP
Vortran Medical Technology 1, Inc.
Anesthesiology · 391d
Cleared Sep 18, 2019
EMS Belt (Model MC0485)
K183103 · NGX
Dongguan Yingfeng Metal & Plastic...
Physical Medicine · 315d
Cleared Sep 18, 2019
OraCure
K183436 · OLR
Tbm Corporation
Dental · 281d
Cleared Sep 18, 2019
4CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS Torrey Pines PEEK...
K190563 · MAX
Solco Biomedical Co., Ltd.
Orthopedic · 197d
Cleared Sep 18, 2019
Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant, JO XTRA...
K190858 · NUC
United Consortium
Obstetrics & Gynecology · 169d
Cleared Sep 18, 2019
geko T-2 and geko T-3 Neuromuscular Stimulators
K191113 · IPF
Firstkind Limited
Physical Medicine · 145d
Cleared Sep 18, 2019
Dornier MINNOW Ureteral Catheter
K191187 · EYB
Dornier Medtech America, Inc.
Gastroenterology & Urology · 138d