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
6553–6576 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jul 17, 2024
3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2)
K241081 · OBO
Topcon Corporation
Ophthalmic · 89d
Cleared Jul 17, 2024
Rayvolve
K240845 · QBS
Azmed Sas
Radiology · 112d
Cleared Jul 17, 2024
Vitrea Software Package, VSTP-002A V2.0
K240705 · LLZ
Canon Medical Systems Corporation
Radiology · 125d
Cleared Jul 17, 2024
S.I.N. Dental Implant System
K240609 · DZE
S.I.N. ? Sistema DE Implante Nacional...
Dental · 135d
Cleared Jul 17, 2024
Sonata Transcervical Fibroid Ablation System 2.2
K240503 · KNF
Gynesonics, Inc.
Obstetrics & Gynecology · 147d
Cleared Jul 17, 2024
ACIST RXi System (016616)
K233904 · DXO
Acist Medical Systems, Inc.
Cardiovascular · 219d
Cleared Jul 16, 2024
SAFElife™ Fentanyl Urine Home Test (Cassette)
K241741 · NGL
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 29d
Cleared Jul 16, 2024
Finesse Injectable™ PTA Balloon Dilatation Catheter
K241740 · LIT
Summa Therapeutics
Cardiovascular · 29d
Cleared Jul 16, 2024
RadiForce RX670
K241441 · PGY
Eizo Corporation
Radiology · 55d
Cleared Jul 16, 2024
Light Cure Adhesive
K241056 · KLE
Sincera Technology (Changchun) Co., Ltd.
Dental · 89d
Cleared Jul 16, 2024
CrossRoads Modular Tray System
K241050 · KCT
Crossroads Extremity Systems
General Hospital · 90d
Cleared Jul 16, 2024
Swoop® Portable MR Imaging® System
K240944 · LNH
Hyperfine, Inc.
Radiology · 102d
Cleared Jul 16, 2024
Electric Scooter (M2085, S2091)
K240272 · INI
Guangdong Prestige Technology Co., Ltd.
Physical Medicine · 167d