FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
4513–4536 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 14, 2025
KOROT Blood Pressure Monitor (KOROT P3 Accurate)
K250091 · DXN
Korot Co., Ltd.
Cardiovascular · 59d
Cleared Mar 14, 2025
Ruby XL System
K250079 · KRD
Penumbra, Inc.
Cardiovascular · 60d
Cleared Mar 14, 2025
Porcelain Powder (Enamel/ Modifier,Stain/Glaze,Stain/Glaze-A,Modeling Fluid )
K250025 · EIH
Aidite (Qinhuangdao) Technology Co.,...
Dental · 67d
Cleared Mar 14, 2025
CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B...
K243931 · OZE
Centers For Disease Control and...
Microbiology · 84d
Cleared Mar 14, 2025
NEXXT MATRIXX® SI System
K243838 · OUR
Nexxt Spine
Orthopedic · 91d
Cleared Mar 14, 2025
Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818)
K243599 · FOZ
Arrow International, LLC (A...
General Hospital · 113d
Cleared Mar 14, 2025
Solution Administration Sets
K243529 · FPA
Baxter Healthcare Corporation
General Hospital · 120d
Cleared Mar 14, 2025
One-Fil Putty
K243353 · KIF
Mediclus Co., Ltd.
Dental · 136d
Cleared Mar 14, 2025
Promisemed Safety Huber Needles
K243332 · PTI
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 141d
Cleared Mar 14, 2025
BodyTom 64
K242811 · JAK
Neurologica Corporation, A Subsidiary...
Radiology · 177d
Cleared Mar 14, 2025
Maestro System (REF100)
K242323 · QZB
Moon Surgical
General & Plastic Surgery · 220d
Cleared Mar 14, 2025
Viewer+
K242244 · QKQ
Lumea, Inc.
Pathology · 226d
Cleared Mar 14, 2025
mBôs (Monogram mBôs TKA System)
K242121 · OLO
Monogram Orthopaedics, Inc.
Orthopedic · 238d
Cleared Mar 14, 2025
Bronchoscope System, The Single-use Bronchoscope (Single-use Bronchoscope:...
K242010 · EOQ
Shenzhen Sanping Image Technology...
Ear, Nose, Throat · 247d
Cleared Mar 14, 2025
DeepRESP
K241960 · OLZ
Nox Medical Ehf
Neurology · 254d
Cleared Mar 14, 2025
VerteGlide Spinal Growth Guidance System
K241816 · PGM
OrthoPediatrics Corp.
Orthopedic · 263d
Cleared Mar 14, 2025
PLANET Onco Dose (3.2)
K241765 · LLZ
Dosisoft SA
Radiology · 267d
Cleared Mar 14, 2025
VITEK COMPACT PRO
K234012 · LON
bioMerieux, Inc.
Microbiology · 451d
Cleared Mar 13, 2025
Turbo-Elite Laser Atherectomy Catheter
K250385 · MCW
Spectranetics
Cardiovascular · 30d
Cleared Mar 13, 2025
Freedom Total Knee System (All-poly Tibial Plate)
K250382 · JWH
Maxx Orthopedics, Inc.
Orthopedic · 30d
Cleared Mar 13, 2025
Surgify Halo (54.085.SHD.H1)
K250380 · HBE
Surgify Medical OY
Neurology · 30d
Cleared Mar 13, 2025
xvision Spine system
K250255 · SBF
Augmedics, Ltd.
Orthopedic · 44d
Cleared Mar 13, 2025
neoLaser Laser Surgery Fibers
K250113 · GEX
G.N.S Neolaser , Ltd.
General & Plastic Surgery · 56d
Cleared Mar 13, 2025
FlowTriever2 Catheter
K250088 · QEW
Inari Medical, Inc.
Cardiovascular · 58d