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
4609–4632 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 03, 2025
VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500)
K243380 · EOB
Olympus Medical Systems Corporation
Ear, Nose, Throat · 124d
Cleared Mar 03, 2025
LVivo Software Application
K243235 · QIH
Dia Imaging Analysis, Ltd.
Radiology · 144d
Cleared Mar 03, 2025
Q Switched Nd:YAG Laser machine (QNHF-01)
K242943 · GEX
Beijing Nubway S&T Co., Ltd.
General & Plastic Surgery · 159d
Cleared Mar 03, 2025
EnergyLounger (TY-01)
K241947 · OHS
Shenzhen Kaiyan Medical Equipment...
General & Plastic Surgery · 243d
Cleared Feb 28, 2025
QIAstat-Dx GI Panel 2 Mini B
K250324 · PCH
QIAGEN GmbH
Microbiology · 23d
Cleared Feb 28, 2025
16ch Flex SPEEDER Medium 1.5T (Q7000246)
K244054 · MOS
Quality Electrodynamics
Radiology · 59d
Cleared Feb 28, 2025
MedalOne Total Knee System
K244039 · JWH
Suzhou Microport Orthorecon Co., Ltd.
Orthopedic · 60d
Cleared Feb 28, 2025
FX CorAL 60 (F00012969)
K243874 · KDI
Fresenius Medical Care Renal...
Gastroenterology & Urology · 73d
Cleared Feb 28, 2025
Xpert C. difficile/Epi
K243730 · OZN
Cepheid
Microbiology · 87d
Cleared Feb 28, 2025
da Vinci SP Advanced Access Port Kit (432701)
K243582 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 100d
Cleared Feb 28, 2025
DYNAMIS™ SI Screw System
K243565 · OUR
Promethean Restorative, LLC
Orthopedic · 102d
Cleared Feb 28, 2025
Seclusion Catheter
K243436 · DQY
Basis Medical
Cardiovascular · 115d
Cleared Feb 28, 2025
MagDI System (MAG-02, DS-01)
K243359 · SAH
Gt Metabolic Solutions, Inc.
General & Plastic Surgery · 122d
Cleared Feb 28, 2025
Pulse Oximeter ( PO2, PO2A, PO2B)
K242876 · DQA
Shenzhen Viatom Technology Co., Ltd.
Anesthesiology · 158d
Cleared Feb 28, 2025
Airmod
K242798 · BZQ
Heroic Faith International , Ltd.
Anesthesiology · 165d
Cleared Feb 28, 2025
Portable Oxygen Concentrator (P2-TOC)
K242718 · CAW
Qingdao Kingon Medical Science and...
Anesthesiology · 171d
Cleared Feb 28, 2025
pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device
K242676 · POL
Phenox Limited
Neurology · 175d
Cleared Feb 28, 2025
Intravascular Extension Sets and Accessories
K242339 · FPA
Baxter Healthcare Corporation
General Hospital · 205d
Cleared Feb 28, 2025
Synea Fusion Handpieces (Intensiv & Profin)
K242179 · EFB
W&H Dentalwerk B?rmoos GmbH
Dental · 218d
Cleared Feb 28, 2025
Myomics
K241922 · QIH
Phantomics, Inc.
Radiology · 242d
Cleared Feb 28, 2025
E1000 Dx Digital Pathology Solution
K241717 · PSY
Shandon Diagnostics Limited
Pathology · 259d
Cleared Feb 28, 2025
Durex Polyisoprene Condom
K241617 · MOL
Rb Health (Us), LLC
Obstetrics & Gynecology · 268d
Cleared Feb 28, 2025
Manual Wheelchair (S002, S004, S005, S006, S007, S008, S009)
K241374 · IOR
Anhui Jbh Medical Apparatus Co., Ltd.
Physical Medicine · 289d
Cleared Feb 28, 2025
Silver Fluoride Hypersensitivity Varnish
K241041 · PHR
Young Dental Manufacturing Co. 1, LLC
Dental · 318d