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
28921–28944 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 05, 2017
LiDCOunity v2 Hemodynamic Monitor
K163334 · DXG
Lidco, Ltd.
Cardiovascular · 189d
Cleared Jun 05, 2017
ElectroTek
K170441 · GWQ
Mobilemedtek
Neurology · 111d
Cleared Jun 05, 2017
Revolution ACT
K171013 · JAK
Ge Hangwei Medical Systems Co., Ltd.
Radiology · 62d
Cleared Jun 02, 2017
MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup
K162395 · DIO
Mp Biomedicals, LLC
Toxicology · 280d
Cleared Jun 02, 2017
Enobio Wireless EEG
K162681 · GWQ
Neuroelectrics Barcelona S.L.U.
Neurology · 249d
Cleared Jun 02, 2017
KeraStat(R) Gel
K162759 · KGN
Keranetics, LLC
General & Plastic Surgery · 245d
Cleared Jun 02, 2017
Galvanic Spa, Model: SKB-1405
K163470 · NFO
Shenzhen Siken 3D Technology...
Neurology · 172d
Cleared Jun 02, 2017
Zio AT ECG Monitoring System
K163512 · QYX
iRhythm Technologies, Inc.
Cardiovascular · 169d
Cleared Jun 02, 2017
Responsive Orthopedics Total Hip Arthroplasty System
K163585 · LZO
Responsive Orthopedics, LLC
Orthopedic · 164d
Cleared Jun 02, 2017
LS-5 ePTFE Suture
K163639 · NBY
Lsi Solutions
General & Plastic Surgery · 161d
Cleared Jun 02, 2017
Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens
K170001 · HQD
Acuity Polymers, Inc.
Ophthalmic · 150d
Cleared Jun 02, 2017
Radiopaque Tissue Marker
K170026 · NEU
Viscus Biologics, LLC
General & Plastic Surgery · 150d
Cleared Jun 02, 2017
Dynamic Coronary Roadmap
K170130 · OWB
Philips Medical Systems Nederland B.V.
Radiology · 140d
Cleared Jun 02, 2017
Reprocessed Agilis NxT Steerable Introducer
K170311 · PNE
Innovative Health, LLC
Cardiovascular · 121d
Cleared Jun 02, 2017
Talos® Lumbar (HA) PEEK IBF Devices
K170395 · MAX
Meditech Spine, LLC
Orthopedic · 114d
Cleared CT Jun 02, 2017
Zepto
K170655 · PUL
Mynosys Cellular Devices, Inc.
Ophthalmic · 91d
Cleared Jun 02, 2017
Biopsy Forceps
K170726 · DWZ
Fehling Instruments GmbH & Co. KG
Cardiovascular · 85d
Cleared Jun 02, 2017
Parcus SLiK Fix Screw
K170877 · MBI
Parcus Medical
Orthopedic · 70d
Cleared Jun 02, 2017
TELIX K Interbody System
K170890 · MAX
Biedermann Motech GmbH & Co. KG
Orthopedic · 67d
Cleared Jun 02, 2017
VitalWatch Software User Interface
K170973 · DRG
Vitalconnect, Inc.
Cardiovascular · 60d
Cleared Jun 02, 2017
Electrocardiograph
K170995 · DPS
Edan Instruments, Inc.
Cardiovascular · 60d
Cleared Jun 02, 2017
OrthoButton AL
K171060 · MBI
Riverpoint Medical
Orthopedic · 53d
Cleared Jun 02, 2017
Closed Male Luer
K171101 · FPA
Yukon Medical
General Hospital · 50d
Cleared Jun 02, 2017
PolyDev Soft Contact Lenses
K171157 · LPL
Polydev , Ltd.
Ophthalmic · 43d