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
20905–20928 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 05, 2020
OptiScanner® 5000 Glucose Monitoring System
K192785 · LZF
Optiscan Biomedical Corporation
Chemistry · 128d
Cleared Feb 05, 2020
DENTCA Crown and Bridge
K192806 · EBG
Dentca, Inc.
Dental · 127d
Cleared Feb 05, 2020
PERLA® TL posterior osteosynthesis system
K193396 · NKB
Spineart
Orthopedic · 61d
Cleared Feb 05, 2020
Endosee System
K200038 · HIH
CooperSurgical, Inc.
Obstetrics & Gynecology · 28d
Cleared Feb 05, 2020
SpineNet SSP System
K200170 · KWQ
Spinenet, LLC
Orthopedic · 13d
Cleared Feb 04, 2020
OKLand Patient Return Electrode Pad
K183148 · GEI
Auckland Medical Polymer(Tianjin)...
General & Plastic Surgery · 448d
Cleared Feb 04, 2020
The Caterpillar and Caterpillar Micro Arterial Embolization Devices
K191532 · KRD
C.R. Bard, Inc.
Cardiovascular · 239d
Cleared Feb 04, 2020
Kurin Blood Culture Collection Set with Kurin Lock Technology, Push-Button...
K191832 · JKA
Kurin, Inc.
General Hospital · 210d
Cleared Feb 04, 2020
s-Clean SQ-SL Implant System Regular
K192688 · DZE
Dentis Co., Ltd.
Dental · 131d
Cleared Feb 04, 2020
KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System
K193320 · OVD
Kyocera Medical Technologies, Inc.
Orthopedic · 64d
Cleared Feb 04, 2020
Motion Correction System
K193324 · LNH
Kineticor, Inc.
Radiology · 64d
Cleared Feb 04, 2020
Summit DuoFix HA Coating
K193398 · MEH
DePuy Orthopaedics, Inc.
Orthopedic · 60d
Cleared Feb 04, 2020
Akesis Galaxy RTx
K200050 · IWB
Akesis, Inc.
Radiology · 25d
Cleared Feb 03, 2020
Comus Locking Plate systems
K190842 · HRS
Jiangsu Trauhui Medical Instrument...
Orthopedic · 308d
Cleared Feb 03, 2020
Bella-mu
K190962 · FMI
U-Needle B.V.
General Hospital · 297d
Cleared Feb 03, 2020
Katalyst Training System
K190966 · NGX
Katalyst, Inc.
Physical Medicine · 297d
Cleared Feb 03, 2020
X-Guide Surgical Navigation System
K192579 · PLV
X-Nav Technologies, LLC
Dental · 137d
Cleared Feb 02, 2020
Mako Total Hip Application
K193128 · OLO
Mako Surgical Corp.
Orthopedic · 82d
Cleared Feb 01, 2020
Optima Coil System
K200030 · HCG
Balt USA, LLC
Neurology · 25d
Cleared Jan 31, 2020
Arc Enterocuff
K191330 · FDA
Boddingtons Plastics, Ltd.
Gastroenterology & Urology · 260d
Cleared Jan 31, 2020
1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support
K191539 · MOS
Rapid Biomedical GmbH
Radiology · 235d
Cleared Jan 31, 2020
TTC Phantom® Intramedullary Nail System
K192163 · HSB
Paragon 28, Inc.
Orthopedic · 175d
Cleared CT Jan 31, 2020
ActiPatch
K192234 · PQY
Bioelectronics Corporation
Physical Medicine · 165d
Cleared Jan 31, 2020
syngo.MR Applications
K192462 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 144d