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
8041–8064 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 19, 2024
MagnetOs Granules
K232347 · MQV
Kuros Biosciences B.V
Orthopedic · 168d
Cleared Jan 19, 2024
Rapid ASPECTS (v3)
K232156 · POK
Ischemaview, Inc.
Radiology · 183d
Cleared Jan 19, 2024
DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix...
K231873 · MEH
Depuy Ireland UC
Orthopedic · 207d
Cleared Jan 19, 2024
BD Vacutainer® Fluoride Blood Collection Tubes
K231237 · JKA
Becton, Dickinson and Company
Chemistry · 266d
Cleared Jan 19, 2024
Distal Access Catheter
K231218 · QJP
Accumedical Beijing , Ltd.
Neurology · 266d
Cleared Jan 19, 2024
HKT Anatomical Locking Trauma System
K231213 · HRS
Hankil Tech Medical Co., Ltd.
Orthopedic · 266d
Cleared Jan 19, 2024
RIGHTEST Blood Glucose Monitoring System Max Tel
K231192 · NBW
Bionime Corporation
Chemistry · 267d
Cleared Jan 19, 2024
Mix2Vial® Transfer Device
K231071 · LHI
West Pharma Services Il, Ltd.
General Hospital · 280d
Cleared Jan 19, 2024
TORPEDO Implant System®
K230817 · OUR
Deltacor GmbH
Orthopedic · 301d
Cleared Jan 19, 2024
Cold Compression Wrap Pro
K230524 · IRP
Chengdu Cryo-Push Medical Technology...
Physical Medicine · 326d
Cleared Jan 19, 2024
Plenity
K230133 · QFQ
Gelesis, Inc.
Gastroenterology & Urology · 367d
Cleared Jan 18, 2024
Minuteman G5 MIS Fusion Plate
K234051 · PEK
Spinal Simplicity, LLC
Orthopedic · 28d
Cleared Jan 18, 2024
TriMed Threaded Intramedullary Nail System
K234040 · HWC
TriMed, Inc.
Orthopedic · 28d
Cleared Jan 18, 2024
Medline UNITE Ancillary Foot Recon Plating System
K234031 · HRS
Medline Industires, LP
Orthopedic · 29d
Cleared Jan 18, 2024
AMF TT Cones
K234011 · JWH
Lima Corporate S.P.A.
Orthopedic · 30d
Cleared Jan 18, 2024
Curiteva Porous PEEK Lumbar Interbody Fusion System
K233744 · MAX
Curiteva, Inc.
Orthopedic · 57d
Cleared Jan 18, 2024
Celect Platinum Vena Cava Filter Set for Femoral Vein Approach...
K233680 · DTK
William Cook Europe Aps
Cardiovascular · 63d
Cleared Jan 18, 2024
EVOLUTION® Tibial Cones
K233507 · MBH
Microport Orthopedics, Inc.
Orthopedic · 79d
Cleared Jan 18, 2024
Arthrex Synergy Vision Endoscopic Imaging System
K233451 · GCJ
Arthrex, Inc.
General & Plastic Surgery · 90d
Cleared Jan 18, 2024
CeQur Simplicity™ On-Demand Insulin Delivery System
K233447 · OPP
Cequr SA
Chemistry · 91d
Cleared Jan 18, 2024
Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2)
K233242 · NQD
Siemens Healthcare Diagnostics, Inc.
Chemistry · 112d
Cleared Jan 18, 2024
NxStage PureFlow Solution
K233213 · KPO
Nxstage Medical, Inc.
Gastroenterology & Urology · 112d
Cleared Jan 18, 2024
ENFit Adaptor
K233190 · PIO
Jiangsu Caina Medical Co.,Ltd
Gastroenterology & Urology · 112d
Cleared Jan 18, 2024
FlashHeal 2 (FlashHeal 2.0)
K233077 · GEX
Inwound Aps
General & Plastic Surgery · 114d