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
20329–20352 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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 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
Cleared Jan 31, 2020
Unshaded Dental Zirconia and Pre-Shaded Dental Zirconia
K192535 · EIH
Qinhuangdao Audental Metal Technology...
Dental · 137d
Cleared Jan 31, 2020
Tamper Evident Cap
K193192 · FMF
International Medical Industries, Inc.
General Hospital · 73d
Cleared Jan 31, 2020
ACUSON Sequoia Diagnostic Ultrasound System
K193257 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 66d
Cleared Jan 31, 2020
ProLift Expandable System
K193258 · MAX
Life Spine, Inc.
Orthopedic · 66d
Cleared Jan 31, 2020
CapLOX II®/TowerLOX® MIS Pedicle Screw System
K193270 · NKB
Captiva Spine, Inc.
Orthopedic · 66d
Cleared Jan 31, 2020
Physica LMC Knee System
K193284 · JWH
Lima Corporate S.P.A.
Orthopedic · 65d
Cleared Jan 31, 2020
BIOEASY Multi-Drug Test Cup
K193480 · NGL
Shenzhen Bioeasy Biotechnology Co., Ltd.
Toxicology · 46d
Cleared Jan 31, 2020
HAD1717MC
K200018 · MQB
H&Abyz
Radiology · 28d
Cleared Jan 30, 2020
Linshom Respiratory Monitoring Device (LRMD)
K190734 · BZQ
Linshom Management, LLC
Anesthesiology · 315d
Cleared Jan 30, 2020
SCS 17-01
K190956 · MQV
Anika Therapeutics, Inc.
Orthopedic · 294d
Cleared Jan 30, 2020
EndoClot
K191254 · PLL
Endoclot Plus Co., Ltd.
Gastroenterology & Urology · 265d
Cleared Jan 30, 2020
TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord
K192339 · KNS
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 155d
Cleared Jan 30, 2020
TruDi Navigation System
K192397 · PGW
Biosense Webster
Ear, Nose, Throat · 149d
Cleared Jan 30, 2020
Neo
K192889 · OMA
Eemagine Medical Imaging Solutions GmbH
Neurology · 112d