FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
18985–19008 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 02, 2020
OsOpia Synthetic Bone Void Filler
K201546 · LYC
Revisios BV
Dental · 115d
Cleared Oct 02, 2020
HAL for Medical Use(Lower Limb type)
K201559 · PHL
Cyberdyne, Inc.
Neurology · 114d
Cleared Oct 02, 2020
Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram...
K201748 · KGO
Hartalega Sdn Bhd
General Hospital · 98d
Cleared Oct 02, 2020
LiverMultiScan
K202170 · LNH
Perspectum, Ltd.
Radiology · 60d
Cleared Oct 02, 2020
Oculus-SA Lumbar Cage System
K202190 · OVD
Neurostructures
Orthopedic · 58d
Cleared Oct 02, 2020
Materialise PKA Guide System
K202207 · HSX
Materialise NV
Orthopedic · 57d
Cleared Oct 02, 2020
ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device
K202218 · QEW
Boston Scientific Corporation
Cardiovascular · 57d
Cleared Oct 02, 2020
Cleerly Labs v2.0
K202280 · LLZ
Cleerly, Inc.
Radiology · 52d
Cleared Oct 02, 2020
Quantum Workstation 12 Elite
K202557 · DRY
Spectrum Medical , Ltd.
Cardiovascular · 29d
Cleared Oct 01, 2020
MectaScope System
K200067 · HRX
Medacta International S.A.
Orthopedic · 262d
Cleared Oct 01, 2020
TELEGRAPH® EVOLUTION Humeral Nailing System
K200127 · HSB
FH Industrie
Orthopedic · 254d
Cleared Oct 01, 2020
SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+
K200544 · CEM
Diamond Diagnostics, Inc.
Chemistry · 212d
Cleared Oct 01, 2020
Infrared PT2L Digital No-Touch Thermometer
K200710 · FLL
Andon Health Co, Ltd.
General Hospital · 197d
Cleared Oct 01, 2020
ECG Cables and Leadwires
K201359 · DSA
Xinkang Medical Instrument Co. , Ltd.
Cardiovascular · 133d
Cleared Oct 01, 2020
Philips Avent Single/Double electric breast pump Advanced
K201381 · HGX
Philips Consumer Lifestyle -...
Obstetrics & Gynecology · 128d
Cleared Oct 01, 2020
HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module
K201446 · DQK
Edwards Lifesiences, LLC
Cardiovascular · 122d
Cleared Oct 01, 2020
Nutricare Clear-ISOSAF Nasogastric Feeding Tube
K202357 · PIF
Three Circles Consulting Limited
Gastroenterology & Urology · 43d
Cleared Sep 30, 2020
THINQ
K192051 · LLZ
Corticometrics, LLC
Radiology · 427d
Cleared Sep 30, 2020
Tua Face Fitness / Tua Trend Face
K192077 · NFO
Vupiesse S.R.L
Neurology · 425d
Cleared Sep 30, 2020
IDS-iSYS Ostase BAP
K200475 · CIN
Immunodiagnostic Systems , Ltd.
Chemistry · 217d
Cleared CT Sep 30, 2020
Clear Guide SCENERGY
K201188 · JAK
Clear Guide Medical
Radiology · 152d
Cleared Sep 30, 2020
e-Ortho Shoulder Software
K201928 · LLZ
FH Industrie
Radiology · 82d
Cleared Sep 30, 2020
EverLift Submucosal Lifting Agent
K202376 · PLL
Gi Supply, Inc.
Gastroenterology & Urology · 41d
Cleared Sep 30, 2020
Allura Vaginal Stent
K202542 · KXP
Pmt Corporation
Obstetrics & Gynecology · 28d