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
38305–38328 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 26, 2014
EZONO 4000
K140254 · IYN
Ezono AG
Radiology · 26d
Cleared Feb 26, 2014
ST SENSE NV 8 ARRAY COIL
K140282 · MOS
Resonance Innovations, LLC
Radiology · 22d
Cleared Feb 25, 2014
EZ TRANSPORT CHAIR
K130517 · IOR
Harris Medical, LLC
Physical Medicine · 363d
Cleared Feb 25, 2014
RETRACTION PASTE
K130580 · MVL
Dmg USA, Inc.
Dental · 357d
Cleared Feb 25, 2014
SE-601 SERIES ELECTROCARDIOGRAPH
K131503 · DPS
Edan Instruments, Inc.
Cardiovascular · 277d
Cleared Feb 25, 2014
E-Z CHECK OZONE TEST STRIPS
K132344 · MSY
Reprocessing Products Corporation (Rpc)
Gastroenterology & Urology · 211d
Cleared Feb 25, 2014
CELLVIZIO 100 SERIES SYSTEM AND CELLVIZIO SYSTEM WITH CONFOCAL MINIPROBES
K132389 · OWN
Daniel & Daniel Consulting
General & Plastic Surgery · 208d
Cleared Feb 25, 2014
SMILEBOND SYSTEM
K132599 · ELW
Millennium Company, LLC
Dental · 189d
Cleared Feb 25, 2014
UP600 DIAGNOSTIC DOPPLER ULTRASOUND SYSTEM
K132690 · IYN
Qisda Corporation
Radiology · 181d
Cleared Feb 25, 2014
SFI-BAR IMPLANT ABUTMENTS
K132814 · NHA
Sterngold Dental, LLC
Dental · 169d
Cleared Feb 25, 2014
INSULIN PEN NEEDLE
K133058 · FMI
Wenzhou Wuzhou Import & Export Co., Ltd.
General Hospital · 151d
Cleared Feb 25, 2014
INSULIN PEN NEEDLE
K133059 · FMI
Wenzhou Beipu Science & Technology...
General Hospital · 151d
Cleared Feb 25, 2014
CISNAP CLOSED INCISION SYSTEM
K133137 · OKO
Spiracur, Inc.
General & Plastic Surgery · 137d
Cleared Feb 25, 2014
ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, ZIMMER PATIENT SPECIFIC...
K133162 · JWH
Materialise NV
Orthopedic · 131d
Cleared Feb 25, 2014
MODIFIED HD GUIDE CATHETER
K133177 · DQY
Concentric Medical, Inc.
Cardiovascular · 131d
Cleared Feb 25, 2014
PRESSON SPINAL FIXATION SYSTEM
K133287 · MNH
Nexus Spine, LLC
Orthopedic · 123d
Cleared Feb 25, 2014
SICAT FUNCTION
K133320 · LLZ
Sicat GmbH & Co. KG
Radiology · 120d
Cleared Feb 25, 2014
LEADLINER CS LEAD DELIVERY SYSTEM
K133501 · DQY
Vascular Solutions, Inc.
Cardiovascular · 103d
Cleared Feb 25, 2014
SYNGO.VIA MI WORKFLOWS
K133644 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 90d
Cleared Feb 25, 2014
NEODENT IMPLANT SYSTEM
K133696 · NHA
Jjgc Industria E Comercio DE...
Dental · 84d
Cleared Feb 25, 2014
CD HORIZON SPINAL SYSTEM GROWTH ROD SET
K133904 · PGM
Medtronic Sofamor Danek USA
Orthopedic · 67d
Cleared Feb 25, 2014
WONDFO MULTI-DRUG URINE TEST CUP, PANEL
K133968 · DKZ
Guangzhou Wondfo Biotech Co., Ltd.
Chemistry · 61d
Cleared Feb 25, 2014
INTONEMV
K134020 · KPI
Incontrol Medical, LLC
Gastroenterology & Urology · 57d
Cleared Feb 25, 2014
MICROCUTTER XCHANGE 30 STAPLER, MICROCUTTER XCHANGE 30 BLUE CARTRIDGE
K140118 · GDW
Cardica, Inc.
General & Plastic Surgery · 40d