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
22177–22200 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 04, 2019
Cartiva SCI instrumentation set
K192156 · QBO
Cartiva, Inc.
Orthopedic · 26d
Cleared Sep 03, 2019
5cc Neuraxial Slip Tip Glass Syringe,5cc Neuraxial Lock Tip Glass Syringe,5cc...
K182765 · FMF
Top Corporation
General Hospital · 340d
Cleared Sep 03, 2019
Geomed Vascular Dilators
K183438 · DWP
Geomed Medizin-Technik GmbH & Co.
Cardiovascular · 265d
Cleared Sep 03, 2019
NuVasive® ACP System
K191500 · KWQ
Nu Vasive, Incorporated
Orthopedic · 89d
Cleared Sep 03, 2019
Syntec Tibial Nail System
K191617 · HSB
Syntec Scientific Corporation
Orthopedic · 77d
Cleared Sep 03, 2019
AcQRef Introducer Sheath
K192106 · DYB
Acutus Medical, Inc.
Cardiovascular · 29d
Cleared Aug 30, 2019
Triton Cage
K183407 · MAX
Medyssey USA, Inc.
Orthopedic · 263d
Cleared Aug 30, 2019
T1-CS, T1-C
K183475 · OAS
Osstem Implant Co., Ltd.
Radiology · 256d
Cleared Aug 30, 2019
Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable...
K190449 · FET
Olympus Medical Systems Corp.
Gastroenterology & Urology · 186d
Cleared Aug 30, 2019
Lumipulse G whole PTH
K190702 · CEW
Fujirebio Diagnostics,Inc.
Chemistry · 165d
Cleared Aug 30, 2019
Artemis Eye System
K190719 · GWG
Penumbra, Inc.
Neurology · 163d
Cleared Aug 30, 2019
OPERA, OPERA eco
K190810 · HGX
Unimom.Co
Obstetrics & Gynecology · 154d
Cleared Aug 30, 2019
Yumizen C1200 ALP, Yumizen C1200 Albumin
K191245 · CJE
HORIBA ABX SAS
Chemistry · 113d
Cleared Aug 30, 2019
Pathfinder Endoscope Overtube
K191415 · FED
Neptune Medical, Inc.
Gastroenterology & Urology · 94d
Cleared Aug 30, 2019
Carnation Ambulatory Monitor
K191471 · DSH
Bardy Diagnostics, Inc.
Cardiovascular · 88d
Cleared Aug 30, 2019
ReliefBand
K191547 · GZJ
Reliefband Technologies, LLC
Neurology · 79d
Cleared Aug 30, 2019
LightWalker Laser System Family
K191554 · GEX
Fotona D.O.O.
General & Plastic Surgery · 79d
Cleared Aug 30, 2019
SelectFlex 072 Neurovascular Access System
K191664 · DQY
Q'Apel Medical
Neurology · 70d
Cleared Aug 30, 2019
Sutter RaVoR Bipolar Electrodes
K191732 · GEI
Sutter Medizintechnik GmbH
Ear, Nose, Throat · 63d
Cleared Aug 30, 2019
Cyclops™ Anterior Cervical Plate System
K191786 · KWQ
Degen Medical, Inc.
Orthopedic · 58d
Cleared Aug 30, 2019
EV1000 Clinical Platform NI, EV1000 Clinical Platform
K192058 · DXN
Edwards Lifesciences, LLC
Cardiovascular · 29d
Cleared Aug 30, 2019
iNSitu Total Hip System
K192071 · LPH
Theken Companies, LLC
Orthopedic · 28d
Cleared Aug 30, 2019
Signature ONE System
K192074 · QHE
Orthosoft Inc. (d/b/a) Zimmer CAS
Orthopedic · 28d
Cleared Aug 29, 2019
SGS Dental Implants System
K182219 · DZE
Sgs International, Ltd.
Dental · 379d