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

Filters: Cleared only ×
175,820 results
23977–24000 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 10, 2019
CONTEC Oxygen Concentrator
K180837 · CAW
Contec Medical System Co., Ltd.
Anesthesiology · 286d
Cleared Jan 10, 2019
OSSIO™ Pin Product Family
K181180 · HTY
OSSIO , Ltd.
Orthopedic · 253d
Cleared Jan 10, 2019
RENASYS Y-Connector
K181204 · OMP
Smith & Nephew Medical Limited
General & Plastic Surgery · 248d
Cleared Jan 10, 2019
CLARUS
K181444 · QER
Carl Zeiss Meditec, Inc.
Ophthalmic · 223d
Cleared Jan 10, 2019
Maxpower Relief
K182120 · NUH
Omron Healthcare, Inc.
Neurology · 157d
Cleared Jan 10, 2019
DIASAFEplusUS
K182367 · FIP
Fresenius Medical Care Renal...
Gastroenterology & Urology · 132d
Cleared Jan 10, 2019
Signal Catheter
K182635 · EZL
Safe Medical Design
Gastroenterology & Urology · 108d
Cleared Jan 10, 2019
DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System
K182636 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 108d
Cleared Jan 10, 2019
Trident HD Specimen Radiography System
K182727 · MWP
Hologic, Inc.
Radiology · 104d
Cleared Jan 10, 2019
STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX...
K182873 · NEW
Ethicon, Inc.
General & Plastic Surgery · 90d
Cleared Jan 10, 2019
Additive Orthopaedics Patient Specific 3D Locking Lattice Plates
K183011 · HRS
Additive Orthopaedics
Orthopedic · 71d
Cleared Jan 10, 2019
VLIFT-s Vertebral Body Replacement System
K183071 · PLR
Stryker Spine
Orthopedic · 66d
Cleared Jan 10, 2019
Kangzhou One Step hCG Test Strip, Kangzhou One Step hCG Test Cassette,...
K183097 · LCX
Weihai Kangzhou Biotechnology...
Chemistry · 64d
Cleared Jan 10, 2019
HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)
K183616 · MQR
M.I. Tech Co., Ltd.
Gastroenterology & Urology · 15d
Cleared Jan 09, 2019
Powder Free White, Blue Sterilized Nitrile Copolymer Surgical Gloves Tested...
K181047 · KGO
Smart Glove Corporation Sdn. Bhd.
General Hospital · 265d
Cleared Jan 09, 2019
Cortical Fixation Systems
K181086 · MBI
Cousin Biotech Sas
Orthopedic · 259d
Cleared Jan 09, 2019
Reliance Lumbar IBF System
K181118 · OVD
Reliance Medical Systems
Orthopedic · 257d
Cleared Jan 09, 2019
G3A 40 Bone Cement
K181282 · LOD
G21, S.R.L.
Orthopedic · 239d
Cleared Jan 09, 2019
DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System
K181637 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 202d
Cleared Jan 09, 2019
PENTAX Medical EPK-3000 Video Imaging System
K182846 · EOB
Pentax of America, Inc.
Ear, Nose, Throat · 92d
Cleared Jan 09, 2019
Fit SA
K182869 · EBF
Shofu Dental Corporation
Dental · 89d
Cleared Jan 09, 2019
MRCP+ v1.0
K183133 · LLZ
Perspectum Diagnostics, Ltd.
Radiology · 57d
Cleared Jan 09, 2019
iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses
K183200 · MUW
C&E GP Specialist, Inc.
Ophthalmic · 51d
Cleared Jan 09, 2019
Wireless Digital Flat Panel Detector
K183422 · MQB
Iray Technology Taicang , Ltd.
Radiology · 30d