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
457–480 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 18, 2026
TearCare System
K262479 · ORZ
Sight Sciences, Inc.
Ophthalmic · 29d
Cleared Aug 18, 2026
Lancing device
K262135 · QRL
Tianjin Huahong Technology Co., Ltd.
General & Plastic Surgery · 54d
Cleared Aug 18, 2026
Lower Limb AI (LLAI)
K261641 · QIH
AI Planning Logic, Inc.
Radiology · 92d
Cleared Aug 18, 2026
HERizon RD5 Resecting Device (5FR1PK)
K260984 · HIH
Axora Medical, Inc.
Obstetrics & Gynecology · 146d
Cleared Aug 18, 2026
NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE...
K260794 · LZA
Kossan International Sdn Bhd
General Hospital · 160d
Cleared Aug 18, 2026
Tympendi™ (810)
K260266 · KHJ
Grace Medical, Inc.
Ear, Nose, Throat · 202d
Cleared Aug 18, 2026
LUOFUCON® Wound Matrix
K254256 · QSZ
Huizhou Foryou Medical Devices Co., Ltd.
General & Plastic Surgery · 232d
Cleared Aug 18, 2026
p17 XR Microcatheter
K254071 · QJP
Wallaby Medical
Neurology · 243d
Cleared Aug 17, 2026
KBA3D (v2.4.0)
K261500 · LLZ
S.M.A.I.O
Radiology · 103d
Cleared Aug 17, 2026
MySOZO Software version 6.1.0.1 (SW version 6.1.0.1)
K260224 · DSB
ImpediMed Limited
Gastroenterology & Urology · 203d
Cleared Aug 17, 2026
KLS Martin IPS Oral-Max Implants - MR Conditional
K260137 · JEY
KLS-Martin L.P.
Dental · 213d
Cleared Aug 17, 2026
MagicScan-1.5, GreenMR Serenity 1.5T
K254250 · LNH
Xingaoyi Medical Equipment Co.,Ltd
Radiology · 231d
Cleared Aug 16, 2026
CN-Suite™
K260563 · OLX
FIND Surgical Sciences Inc. D/B/A...
Neurology · 178d
Cleared Aug 14, 2026
BAGUERA® C Cervical Disc Surgical Instruments
K262639 · QLQ
Spineart SA
Orthopedic · 16d
Cleared Aug 14, 2026
EnCor EnCompass™ Breast Biopsy and Tissue Removal System
K262571 · KNW
Bard Peripheral Vascular, Inc.
General & Plastic Surgery · 21d
Cleared Aug 14, 2026
Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)
K262552 · FGB
Scivita Medical Technology Co., Ltd.
Gastroenterology & Urology · 21d
Cleared Aug 14, 2026
AutoContour (RADAC V6)
K262452 · QKB
Radformation, Inc.
Radiology · 28d
Cleared Aug 14, 2026
AdvaView
K262449 · LLZ
ADVAHEALTH SOLUTIONS, LLC
Radiology · 29d
Cleared Aug 14, 2026
Willow 12 Guidewire
K262424 · MOF
Arbor Endovascular, LLC
Neurology · 29d
Cleared Aug 14, 2026
MICRUSFRAME (MFR100202)
K262419 · HCG
Cerenovus, Inc.
Neurology · 30d
Cleared Aug 14, 2026
52Fr ViSiGi LUX™
K261890 · KNT
Boehringer Laboratories, LLC
Gastroenterology & Urology · 70d
Cleared Aug 14, 2026
Redermax® Antibacterial Wound Matrix
K261646 · FRO
Beijing Kreate Medical Co., Ltd.
General & Plastic Surgery · 88d
Cleared Aug 14, 2026
NC Euphora Rapid Exchange Balloon Dilatation Catheter
K261428 · LOX
Medtronic, Ireland
Cardiovascular · 106d
Cleared Aug 14, 2026
QuickVision Ultimate rTMS
K261228 · OBP
Brain Ultimate, Inc.
Neurology · 121d