FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
10993–11016 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 03, 2023
Electronic Sphygmomanometers
K222394 · DXN
Qingdao Yasee Medical Device Co., Ltd.
Cardiovascular · 207d
Cleared Mar 03, 2023
FreeStyle Libre 2 Flash Glucose Monitoring System
K222447 · QBJ
Abbott Diabetes Care, Inc.
Chemistry · 200d
Cleared Mar 03, 2023
imani i2Plus Breast Pump
K222573 · HGX
Imani Co.
Obstetrics & Gynecology · 190d
Cleared Mar 03, 2023
Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i
K222819 · JAK
Canon Medical Systems Corporation
Radiology · 165d
Cleared Mar 03, 2023
Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie)
K222880 · KNT
Endolumik, Inc.
Gastroenterology & Urology · 162d
Cleared Mar 03, 2023
Grappler Suture Anchor R3FLEX IOL System
K223589 · MBI
Paragon 28, Inc.
Orthopedic · 92d
Cleared Mar 03, 2023
PEEK Spinal Infusion Cage
K223776 · MAX
Changzhou Geasure Medical Apparatus...
Orthopedic · 77d
Cleared Mar 03, 2023
EZ Bond Universal
K230009 · KLE
Meta Biomed Co., Ltd.
Dental · 59d
Cleared Mar 03, 2023
Light Based Hair Removal Device GP592
K230060 · OHT
Shenzhen Gsd Tech Co., Ltd.
General & Plastic Surgery · 53d
Cleared Mar 03, 2023
Lyra Influenza A+B Assay
K230236 · OZE
Quidel Corporation
Microbiology · 32d
Cleared Mar 03, 2023
Rebellion, Phantom Multi-Bite Kerrison Rongeur
K230256 · HAE
Morpheus AG
Neurology · 31d
Cleared Mar 03, 2023
CoverScan (CoverScan v1.1)
K230294 · LLZ
Perspectum
Radiology · 29d
Cleared Mar 02, 2023
iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound...
K221340 · EOQ
Boston Scientific Corporation
Anesthesiology · 297d
Cleared Mar 02, 2023
ReWalk P6.0
K221696 · PHL
Re Walk Robotics , Ltd.
Neurology · 265d
Cleared Mar 02, 2023
BoneView
K222176 · QBS
Gleamer
Radiology · 223d
Cleared Mar 02, 2023
6F Wallaby Long Sheath
K222603 · DQY
Wallaby Medical, Inc.
Neurology · 185d
Cleared Mar 02, 2023
Rapid NCCT Stroke
K222884 · QAS
Ischemaview, Inc.
Radiology · 161d
Cleared Mar 02, 2023
1.5T 24E Posterior Array
K223203 · LNH
Shenzhen RF Tech Co., Ltd.
Radiology · 139d
Cleared Mar 02, 2023
Tenderfoot
K223352 · FMK
Accriva Diagnostics, Inc.
General & Plastic Surgery · 120d
Cleared Mar 02, 2023
Artix AX
K223436 · QEW
Inari Medical
Cardiovascular · 108d
Cleared Mar 02, 2023
Plasma Pen (Plasma MD)
K223440 · QVJ
Plasma Concepts
General & Plastic Surgery · 108d
Cleared Mar 02, 2023
Insulin Syringe
K223453 · FMF
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 106d
Cleared Mar 02, 2023
Traumatic brain injury (TBI) test
K223602 · QAT
Abbott Laboratories
Immunology · 90d
Cleared Mar 02, 2023
NEBA® Compact EEG2R Mobile Headset
K223628 · OMC
Neba Health, LLC
Neurology · 87d