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
6265–6288 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 19, 2024
Suture Button Repair System
K240835 · MBI
Skeletal Dynamics, Inc.
Orthopedic · 115d
Cleared Jul 19, 2024
Premium Teeth Resin
K240538 · EBG
Formlabs Ohio, Inc.
Dental · 144d
Cleared Jul 19, 2024
IntelliBlate Microwave Ablation System Console (IB-CON)
K240480 · NEY
Varian Medical Systems, Inc.
General & Plastic Surgery · 150d
Cleared Jul 19, 2024
VACUETTE® QUICKSHIELD Complete (Plus)
K233979 · JKA
Greiner Bio-One North America, Inc.
General Hospital · 214d
Cleared Jul 19, 2024
VasoGuard (V10, V8, V6, V4, V2)
K233976 · JOP
Corvascular Diagnostics, LLC
Cardiovascular · 217d
Cleared Jul 19, 2024
Senhance Surgical System
K233866 · NAY
Asensus Surgical, Inc.
General & Plastic Surgery · 226d
Cleared Jul 19, 2024
Wireless TENS & EMS (Model SM9110,SM9113,SM9116)
K233067 · NUH
Chongqing Rob Linka Science and...
Neurology · 297d
Cleared Jul 18, 2024
vRad Viewer
K241879 · LLZ
Virtual Radiologic Corporation
Radiology · 20d
Cleared Jul 18, 2024
Electric Wheelchair (MP201C)
K241463 · ITI
Suzhou Master Machinery Manufacturing...
Physical Medicine · 56d
Cleared Jul 18, 2024
Juliet® Ti LL Lumbar Interbody Device
K241321 · OVD
Spineart SA
Orthopedic · 69d
Cleared Jul 18, 2024
Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay
K241240 · QOF
Hologic, Inc.
Microbiology · 76d
Cleared Jul 18, 2024
Quantum Perfusion Hybrid System
K241206 · DTN
Spectrum Medical S.R.L.
Cardiovascular · 79d
Cleared Jul 18, 2024
HardyDisk AST Cefiderocol 30µg (FDC30)
K241060 · JTN
Hardy Diagnostics
Microbiology · 91d
Cleared Jul 18, 2024
B4C System - Addition of new sensor model (BcSs-PICNIW-2000)
K240821 · GWM
Braincare Desenvolvimento E Inova??o...
Neurology · 115d
Cleared Jul 18, 2024
Surgical Drive System (Model: ES70, ES90, E8)
K240340 · DZI
Guangdong Jinme Medical Technology...
Dental · 164d
Cleared Jul 18, 2024
CEFALY Connected - OTC, CEFALY Connected - Rx
K234029 · PCC
Cefaly Technology
Neurology · 211d
Cleared Jul 18, 2024
ICHOR 7F Embolectomy System (ICH-7F)
K233917 · QEW
Ichor
Cardiovascular · 219d
Cleared Jul 18, 2024
Papacarie Duo
K233768 · LBH
Elevate Oral Care
Dental · 237d
Cleared Jul 18, 2024
Equinoxe® Central Screw Baseplate System
K233482 · PHX
Exactech, Inc.
Orthopedic · 266d
Cleared Jul 18, 2024
SOLID CLIP™ Single Use Clip Applier
K221495 · FZP
Medscope Biotech Co., Ltd.
General & Plastic Surgery · 787d
Cleared Jul 18, 2024
Field Shield Wound Dressing
K212521 · FRO
Kericure, Inc.
General & Plastic Surgery · 1073d
Cleared Jul 17, 2024
Stable-C Interbody System
K241467 · OVE
Nexus Spine, LLC
Orthopedic · 55d
Cleared Jul 17, 2024
sagAlign Lumbar Cage System (Various PNs)
K241413 · MAX
Acuity Surgical Devices, LLC
Orthopedic · 61d
Cleared Jul 17, 2024
MICSI-RMT
K241121 · LLZ
Microstructure Imaging, Inc.
Radiology · 85d