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

Filters: Cleared only ×
175,820 results
27409–27432 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 21, 2017
S.I.N. Dental Implant System
K170398 · DZE
S.I.N. ? Sistema DE Implante Nacional...
Dental · 285d
Cleared Nov 21, 2017
Automatic Wrist Bluetooth Blood Pressure Monitor
K170545 · DXN
Truly Instrument , Ltd.
Cardiovascular · 270d
Cleared Nov 21, 2017
3M Tegaderm Antimicrobial Transparent Dressing, 3M Tegaderm Antimicrobial...
K170754 · FRO
3M Company, 3M Healthcare
General & Plastic Surgery · 253d
Cleared Nov 21, 2017
TXM Support Catheter
K170914 · DQY
Texasmedical Technologies, Inc.
Cardiovascular · 238d
Cleared Nov 21, 2017
TXM Hydrophilic Guidewire
K170915 · DQX
Texasmedical Technologies, Inc.
Cardiovascular · 238d
Cleared Nov 21, 2017
Climax Personal Lubricant
K171044 · NUC
Wsm Investment, LLC, Dba Topco Sales
Obstetrics & Gynecology · 228d
Cleared Nov 21, 2017
Smith & Nephew, Inc. REDAPT Augments
K171073 · LPH
Smith & Nephew, Inc.
Orthopedic · 224d
Cleared Nov 21, 2017
Surgical Angle Handpiece, Surgical Straight Handpiece
K171155 · KMW
Nakanishi, Inc.
Dental · 215d
Cleared Nov 21, 2017
Alere Afinion HbA1c and ACR on Afinion 2 analyzer
K171650 · LCP
Abbott Rapid Diagnostics
Chemistry · 169d
Cleared Nov 21, 2017
Hermes Medical Imaging Suite v5.7
K171681 · KPS
Hermes Medical Solutions AB
Radiology · 168d
Cleared Nov 21, 2017
Hybrid3D
K171719 · KPS
Hermes Medical Solutions AB
Radiology · 165d
Cleared Nov 21, 2017
Follicle Aspiration Set, Reduced Single Lumen
K172050 · MQE
Vitrolife Sweden AB
Obstetrics & Gynecology · 138d
Cleared Nov 21, 2017
Parkell Universal Adhesive
K172176 · KLE
Parkell, Inc.
Dental · 125d
Cleared Nov 21, 2017
MIM – Y90 Dosimetry
K172218 · LLZ
Mim Software, Inc.
Radiology · 120d
Cleared Nov 21, 2017
Altus Spine Cervical Interbody Fusion System
K172253 · ODP
Altus Partners, LLC
Orthopedic · 118d
Cleared Nov 21, 2017
Microcyn Antimicrobial Skin and Wound Cleanser
K172622 · FRO
Sonoma Pharmaceuticals
General & Plastic Surgery · 81d
Cleared Nov 21, 2017
LiverMultiScan
K172685 · LNH
Perspectum Diagnostics, Ltd.
Radiology · 76d
Cleared Nov 21, 2017
GentleCath Intermittent Urinary Catheter
K172924 · KOD
Convatec Limited
Gastroenterology & Urology · 57d
Cleared Nov 21, 2017
Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath,...
K172995 · DYB
Terumo Medical Corporation
Cardiovascular · 55d
Cleared Nov 21, 2017
Vertera Spine Cohere Cervical Interbody Fusion Device
K173030 · ODP
Nu Vasive, Incorporated
Orthopedic · 54d
Cleared Nov 21, 2017
Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly,...
K173037 · GEH
Galil Medical, Inc.
General & Plastic Surgery · 54d
Cleared Nov 21, 2017
LAP-iX
K173112 · GEI
Sejong Medical Co., Ltd.
General & Plastic Surgery · 53d
Cleared Nov 20, 2017
LIA Pregnancy Test
K171136 · LCX
Lia Diagnostics
Chemistry · 217d
Cleared Nov 20, 2017
B7 2C Occlusion Balloon
K171492 · EOQ
Spiration, Inc.
Ear, Nose, Throat · 182d