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
28105–28128 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 08, 2017
BM.IRIS
K171648 · GEX
Bluecore Co., Ltd.
General & Plastic Surgery · 95d
Cleared Sep 08, 2017
Powder Free Nitrile Examination Glove
K171667 · LZA
Professional Latex Sdn Bhd
General Hospital · 95d
Cleared Sep 08, 2017
CuffLink Implant System
K171725 · MBI
Conmed Corporation
Orthopedic · 88d
Cleared Sep 08, 2017
Luer-Jack Slip 3 ml, Luer-Jack Slip 5 ml, Luer-Jack Slip 20 ml, Luer-Jack...
K171805 · FMF
Conceptomed AS
General Hospital · 81d
Cleared Sep 08, 2017
Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian),...
K171893 · MAX
Bluestone Synergy
Orthopedic · 74d
Cleared Sep 08, 2017
APTUS(R) Wrist 2.5 System
K172170 · HRS
Medartis AG
Orthopedic · 52d
Cleared Sep 07, 2017
S4 Screw System™
K162171 · HWC
Subchondral Solutions
Orthopedic · 400d
Cleared Sep 07, 2017
XableCath Support Catheter
K170041 · DQY
Xablecath, Inc.
Cardiovascular · 245d
Cleared Sep 07, 2017
Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex Mini
K170381 · GEI
Medtronic Advanced Energy
General & Plastic Surgery · 212d
Cleared Sep 07, 2017
Cranial Drill Bits and Accessories
K170442 · HBE
Ad-Tech Medical Instrument Corporation
Neurology · 205d
Cleared Sep 07, 2017
T-Rex Standalone ALIF
K170855 · OVD
Siats, LLC
Orthopedic · 169d
Cleared Sep 07, 2017
NeuroQuant
K170981 · LLZ
Cortechs Labs, Inc.
Radiology · 157d
Cleared Sep 07, 2017
Implantium II
K171126 · DZE
Dentium Co., Ltd.
Dental · 143d
Cleared Sep 07, 2017
FuckWater
K171730 · NUC
Non-Friction Products, Inc.
Obstetrics & Gynecology · 87d
Cleared Sep 07, 2017
NICO BrainPath
K172433 · GZT
Nico Corporation
Neurology · 27d
Cleared Sep 07, 2017
Reliance Cervical IBF System
K172489 · ODP
Reliance Medical Systems, LLC
Orthopedic · 21d
Cleared Sep 06, 2017
The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS,...
K161586 · CAF
Shenzhen Homed Medical Device Co., Ltd.
Anesthesiology · 455d
Cleared Sep 06, 2017
Poseidon Ultrasound System
K163510 · IYN
Butterfly Network, Inc.
Radiology · 265d
Cleared Sep 06, 2017
QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash®...
K163538 · NBS
Inova Diagnostics, Inc.
Immunology · 264d
Cleared Sep 06, 2017
Dentis Dental Implant System
K171027 · DZE
Dentis Co., Ltd.
Dental · 154d
Cleared Sep 06, 2017
Katalyst Mark 1 Muscle Stimulation System
K171035 · NGX
Katalyst, Inc.
Physical Medicine · 153d
Cleared Sep 06, 2017
Central Monitoring System
K171178 · HGM
Edan Instruments, Inc.
Obstetrics & Gynecology · 138d
Cleared Sep 06, 2017
Tritanium C Anterior Cervical Cage
K171496 · ODP
Stryker Spine
Orthopedic · 107d
Cleared Sep 06, 2017
QuadraSphere Microspheres
K172372 · KRD
Biosphere Medical, S.A.
Neurology · 30d