FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
8449–8472 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 02, 2023
BASE290 LED Curing Light
K233518 · EBZ
Handpiece Headquarters
Dental · 1d
Cleared Nov 02, 2023
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0)
K233407 · PZX
AtriCure, Inc.
Cardiovascular · 28d
Cleared Nov 02, 2023
BioSieveTM Multi-Drug Urine Test Panel
K233062 · NFT
Vivachek Biotech (Hangzhou) Co., Ltd.
Toxicology · 37d
Cleared Nov 02, 2023
EpiZact
K233056 · FMF
Guidestar Medical Devices
Anesthesiology · 38d
Cleared Nov 02, 2023
Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor
K232725 · MBI
Suzhou Endophix Co., Ltd.
Orthopedic · 57d
Cleared Nov 02, 2023
Nd:Yag Laser Therapy Systems
K232532 · GEX
Beijing Unt Technology Co., Ltd.
General & Plastic Surgery · 73d
Cleared Nov 02, 2023
ATEC Posterior Navigated Disc Prep Instruments
K232345 · OLO
Alphatec Spine, Inc.
Orthopedic · 90d
Cleared Nov 02, 2023
STELLAR Knee
K232176 · SBF
Polarisar, Inc.
Orthopedic · 104d
Cleared Nov 02, 2023
Fibercure
K232076 · QNF
Lumendo AG
Dental · 112d
Cleared Nov 02, 2023
VersaWrap Nerve Protector
K232029 · JXI
Alafair Biosciences, Inc.
Neurology · 118d
Cleared Nov 02, 2023
XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F...
K230800 · KPR
GEMSS HEALTHCARE CO., LTD.
Radiology · 224d
Cleared Nov 02, 2023
ENFit to ENFit Extension Sets
K230326 · PIF
Vesco Medical
Gastroenterology & Urology · 269d
Cleared Nov 01, 2023
TERA HARZ II
K233502 · EBF
Graphy, Inc.
Dental · 1d
Cleared Nov 01, 2023
Bard 3DMax Mesh
K233402 · FTL
Davol Inc., Subsidiary of C. R. Bard,...
General & Plastic Surgery · 28d
Cleared Nov 01, 2023
Inzii Ripstop Redeployable Retrieval System
K232880 · GCJ
Applied Medical Resources Corporation
General & Plastic Surgery · 44d
Cleared Nov 01, 2023
Aventus Thrombectomy System
K232730 · QEW
Inquis Medical
Cardiovascular · 55d
Cleared Nov 01, 2023
CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009)
K231414 · DTZ
Chalice Medical , Ltd.
Cardiovascular · 169d
Cleared Nov 01, 2023
OptiMesh Multiplanar Expandable Interbody Fusion System
K230927 · OQB
Spineology, Inc.
Orthopedic · 212d
Cleared Oct 31, 2023
LINQ II™ Insertable Cardiac Monitor (LNQ22)
K233320 · MXD
Medtronic, Inc.
Cardiovascular · 32d
Cleared Oct 31, 2023
FlexCath Contour™ Steerable Sheath
K232321 · DRA
Medtronic, Inc.
Cardiovascular · 89d
Cleared Oct 31, 2023
VICTORY™ Lumbar Plate System
K232318 · KWQ
Globus Medical, Inc.
Orthopedic · 89d
Cleared Oct 31, 2023
Sensititre 20-24 hour Haemophilus influenzaelStreptococcus pneumoniae MIC or...
K232310 · JWY
Thermo Fisher Scientific
Microbiology · 90d
Cleared Oct 31, 2023
HemoSphere Alta Advanced Monitoring Platform
K232294 · DQK
Edwards Lifesciences, LLC
Cardiovascular · 91d
Cleared Oct 31, 2023
Neodent Implant System - GM Zygomatic Implant System
K232099 · DZE
JJGC Ind?stria e Com?rcio de...
Dental · 110d