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
649–672 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 28, 2026
See-Mode Augmented Reporting Tool, Breast (SMART-B)
K260303 · QDQ
See-Mode Technologies Pty, Ltd.
Radiology · 179d
Cleared Jul 28, 2026
Revi System
K253651 · QXM
Bluewind Medical , Ltd.
Gastroenterology & Urology · 250d
Cleared Jul 28, 2026
BodyTom Elite (NL4000)
K253450 · JAK
NeuroLogica Corp., a Samsung Company
Radiology · 299d
Cleared Jul 27, 2026
ND Needle Guidance System
K262474 · ITX
Accurate Access, LLC
Radiology · 10d
Cleared Jul 27, 2026
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8...
K262201 · PPN
Shockwave Medical, Inc.
Cardiovascular · 28d
Cleared Jul 27, 2026
Euphora Rapid Exchange (RX) Balloon Dilatation Catheter
K261759 · LOX
Medtronic, Ireland
Cardiovascular · 60d
Cleared Jul 27, 2026
FlexTract Deflectable-Rotational Dilator Sheath Set
K261310 · DRE
Merit Medical Systems, Inc.
Cardiovascular · 97d
Cleared Jul 27, 2026
Philips EPIQ Series Diagnostic Ultrasound System
K261211 · IYN
Philips Ultrasound, LLC
Radiology · 104d
Cleared Jul 27, 2026
Powered Aventus Thrombectomy System™
K261105 · QEZ
Inquis Medical
Cardiovascular · 115d
Cleared Jul 27, 2026
ARCHIMEDES Biodegradable Stent (Medium)
K260835 · FGE
Q3 Medical USA, LLC (C/O Q3 Medical...
Gastroenterology & Urology · 136d
Cleared Jul 27, 2026
Air Compression Massager (HY-1165)
K260529 · IRP
Xiamen High Top Electronic Technology...
Physical Medicine · 160d
Cleared Jul 26, 2026
Corsano CardioWatch 287-2 System
K261367 · MSX
Corsano Health B.V.
Neurology · 90d
Cleared Jul 26, 2026
CorVista System® with PCWP Add-On
K253576 · DQK
Analytics For Life, Inc.
Cardiovascular · 251d
Cleared Jul 25, 2026
MONARCH™ Platform (MON-000008)
K260382 · EOQ
Auris Health, Inc.
Ear, Nose, Throat · 170d
Cleared Jul 25, 2026
METICULY Patient-specific CMF solution
K253206 · JEY
Meticuly Co., Ltd.
Dental · 302d
Cleared Jul 24, 2026
TheraSphere 360™ Y-90 Management Platform
K262462 · LLZ
Boston Scientific Corporation
Radiology · 7d
Cleared Jul 24, 2026
LumenCare Azure
K262383 · JAQ
Nucletron B.V.
Radiology · 11d
Cleared Jul 24, 2026
dS FootAnkle 16Ch 1.5T
K262294 · MOS
Philips Medical Systems Nederland B.V.
Radiology · 17d
Cleared Jul 24, 2026
REMEDY POLY+PLUS SNAP FIT Acetabular Cup
K262290 · KWL
Osteoremedies, LLC
Orthopedic · 18d
Cleared Jul 24, 2026
FARADRIVE™ Steerable Sheath (M004PF21M402)
K262165 · DRA
Boston Scientific Corporation
Cardiovascular · 28d
Cleared Jul 24, 2026
VS-370CF, VS-370CT
K262152 · FCX
VISION MEDICAL Co., Ltd.
Gastroenterology & Urology · 29d
Cleared Jul 24, 2026
Ion-L Navigated Instruments
K262121 · OLO
SurGenTec, LLC
Orthopedic · 31d
Cleared Jul 24, 2026
VERAFEYE Imaging Catheter (VF-VIC-002)
K261849 · OBJ
Luma Vision Limited
Cardiovascular · 51d
Cleared Jul 24, 2026
Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60
K261781 · JTN
Thermo Fisher Scientific (Oxoid Ltd.)
Microbiology · 56d