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
35689–35712 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 18, 2014
ZIGIWIRE MODE2 GUIDEWIRE WIRE SYSTEM, ZIGIWIRE MODE3 GUIDEWIRE WIRE SYSTEM
K141218 · DQX
Vadiswire Corporation
Cardiovascular · 220d
Cleared Dec 18, 2014
FASTFORWARD
K141420 · HTN
MedShape, Inc.
Orthopedic · 203d
Cleared Dec 18, 2014
BECTON DICKINSON INTELLIPORT SYSTEM
K141474 · PHC
Becton, Dickinson & CO
General Hospital · 198d
Cleared Dec 18, 2014
VDRIVE SYSTEM/ VDRIVE DUO/ VDRIVE WITH V-CAS
K141530 · DXX
Stereotaxis, Inc.
Cardiovascular · 192d
Cleared Dec 18, 2014
KIMGUARD ONE STEP STERILIZATION WRAP
K141712 · FRG
Halyard Health
General Hospital · 176d
Cleared Dec 18, 2014
DENTAL LITHIUM DISILICATE GLASS CERAMIC BLOCK (UP. PRESS SERIES AND UP. CAD...
K141727 · EIH
Liaoning Upcera Co., Ltd.
Dental · 175d
Cleared Dec 18, 2014
TRISTAR BONE GRAFT FIXATION SYSTEM
K141764 · JEY
Impladent , Ltd.
Dental · 170d
Cleared Dec 18, 2014
VIBRANCE KEGEL DEVICE (VKD)
K141893 · HIR
Bioinfinity (M) Sdn. Bhd.
Gastroenterology & Urology · 157d
Cleared Dec 18, 2014
INSYNC ZR HIGH TRANSLUCENCY ZIRCONIA
K142043 · EIH
Jensen Industries, Inc.
Dental · 143d
Cleared Dec 18, 2014
MULTIX FUSION VA30 & VA40
K142049 · KPR
Siemens Medical Solutions USA, Inc.
Radiology · 143d
Cleared Dec 18, 2014
CPS Aim MediGuide Enabled inner catheter, CPS Aim Mediguide Enabled inner...
K142235 · DQY
St Jude Medical
Cardiovascular · 127d
Cleared Dec 18, 2014
CPS Direct MediGuide Enabled outer catheter
K142239 · DQY
St Jude Medical
Cardiovascular · 127d
Cleared Dec 18, 2014
SMART LABEL, PROPOFOL
K142333 · MRZ
American I.V. Products, Inc. Dba Aiv,...
General Hospital · 119d
Cleared Dec 18, 2014
NacrousPowder Free Vinyl Patient Examination Gloves, Clear (non-colored)
K142342 · LYZ
Nacrous Plastic Co., Ltd.
General Hospital · 119d
Cleared Dec 18, 2014
Interspinous Plate System
K142378 · PEK
Precision Spine, Inc.
Orthopedic · 114d
Cleared Dec 18, 2014
Quickie, Zippie
K142457 · ITI
Sunrise Medical (Us), LLC
Physical Medicine · 107d
Cleared Dec 18, 2014
Bio2 CLM BG Bioactive Scaffold
K142463 · MQV
Bio2 Technologies, Inc.
Orthopedic · 107d
Cleared Dec 18, 2014
SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura)...
K142488 · MAX
Seaspine, Inc.
Orthopedic · 105d
Cleared Dec 18, 2014
UniWeb 8.0
K142514 · LLZ
Ebm Technologies Incorporated
Radiology · 101d
Cleared Dec 18, 2014
Powder Free Vinyl Patient Examination Gloves ( Yellow, White, BLue, Pink )
K142570 · LYZ
Ever Light Plastic Products Co., Ltd.
General Hospital · 97d
Cleared Dec 18, 2014
Nitrile Powder Free Examination Glove (Blue)
K142588 · LZA
Hartalega Sdn Bhd
General Hospital · 94d
Cleared Dec 18, 2014
CR3 Keyless Split Sample Cup Nortriptyline-Buprenorphine
K142609 · LFG
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 93d
Cleared Dec 18, 2014
Snap Insulin Pump System
K142619 · LZG
Asante Solutions, Inc.
General Hospital · 93d
Cleared Dec 18, 2014
Hermes Medical Imaging Suite v5.5
K142631 · KPS
Hermes Medical Solutions AB
Radiology · 92d