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
23401–23424 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 27, 2019
WOLF Thrombectomy Device
K182835 · QEW
880 Medical, LLC
Cardiovascular · 169d
Cleared Mar 27, 2019
Mimics Medical
K183105 · LLZ
Materialise NV
Radiology · 139d
Cleared Mar 27, 2019
AMSCO 600 Steam Sterilizer
K183410 · FLE
STERIS Corporation
General Hospital · 107d
Cleared Mar 27, 2019
Wearable Device, Home Package in Carry Case with Homehub, Home Package in...
K190073 · MSX
Current Health , Ltd.
Cardiovascular · 70d
Cleared Mar 27, 2019
Tyto Thermometer
K190242 · FLL
Tyto Care , Ltd.
General Hospital · 49d
Cleared Mar 27, 2019
CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B...
K190302 · OZE
Centers For Disease Control and...
Microbiology · 43d
Cleared Mar 27, 2019
Responsive Arthroscopy Wedge Push-In Suture Anchors
K190446 · MBI
Responsive Arthroscopy, LLC
Orthopedic · 30d
Cleared Mar 27, 2019
VITROS XT Chemistry Products TRIG-CHOL Slides
K190490 · CHH
Ortho-Clinical Diagnostics, Inc.
Chemistry · 27d
Cleared Mar 26, 2019
MobileECG 2 BT
K181658 · DSI
Memtec Corporation
Cardiovascular · 274d
Cleared Mar 26, 2019
transGlideXT Expandable Introducer
K181817 · DYB
Transaortic Medical, Inc.
Cardiovascular · 260d
Cleared Mar 26, 2019
Electric Handpiece Motor
K181858 · EBW
W&H Dentalwerk Buermoos GmbH
Dental · 257d
Cleared Mar 26, 2019
Velano Vascular Q2 Extension Set
K182897 · FPA
Velano Vascular
General Hospital · 161d
Cleared Mar 26, 2019
Dental Pain Eraser
K182947 · LWM
Synapse Dental, LLC
Dental · 154d
Cleared Mar 26, 2019
SM Electrodes
K183154 · GXY
Hong Qiangxing (Shenzhen) Electronics...
Neurology · 132d
Cleared Mar 26, 2019
Arthrex TensionLoc System
K183628 · HWC
Arthrex, Inc.
Orthopedic · 90d
Cleared Mar 26, 2019
Synapse PACS
K190232 · LLZ
Fujifilm Corporation
Radiology · 48d
Cleared Mar 26, 2019
WaveLight FS200 Patient Interface
K190392 · GEX
Alcon Laboratories, Inc.
Ophthalmic · 35d
Cleared Mar 26, 2019
OTIS Optical Coherence Tomography SYstem
K190404 · NQQ
Perimeter Medical Imaging, Inc.
General & Plastic Surgery · 35d
Cleared Mar 25, 2019
InTouch Thermal Camera
K181716 · LHQ
Intouch Technologies, Inc., D.B.A....
Radiology · 270d
Cleared Mar 25, 2019
MUTARS Proximal Femur Replacement System
K181778 · MEH
Implantcast GmbH
Orthopedic · 265d
Cleared Mar 25, 2019
AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced...
K181905 · PCU
Boston Scientific Corporation
Gastroenterology & Urology · 252d
Cleared Mar 25, 2019
Ballancer Gold, 1212
K190015 · IRP
Mego Afek AC , Ltd.
Physical Medicine · 81d
Cleared Mar 25, 2019
Rezum Delivery Device, Rezum Generator
K190093 · KNS
Nxthera (A Boston Scientific Company)
Gastroenterology & Urology · 66d
Cleared Mar 24, 2019
Arm Blood Pressure Monitor
K183491 · DXN
Xuzhou Yongkang Electronic Science...
Cardiovascular · 97d