FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
4321–4344 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 05, 2025
CROSSLEAD 0.018inch
K242597 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 187d
Cleared Mar 05, 2025
Access Cortisol
K242190 · CGR
Beckman Coulter, Inc.
Chemistry · 223d
Cleared Mar 05, 2025
NovoSorb® MTX
K242149 · QSZ
Polynovo Biomaterials Pty, Ltd.
General & Plastic Surgery · 225d
Cleared Mar 05, 2025
Prostate MR AI (VA10A)
K241770 · QDQ
Siemens Healthcare GmbH
Radiology · 258d
Cleared Mar 05, 2025
Wellead® Hydrophilic Intermittent Catheter Ready to Use
K241734 · GBM
Well Lead Medical Co., Ltd.
Gastroenterology & Urology · 261d
Cleared Mar 04, 2025
Ceevra Reveal 3+
K243933 · QIH
Ceevra, Inc.
Radiology · 74d
Cleared Mar 04, 2025
Biolox® Delta Revision heads
K243809 · LZO
Limacorporate
Orthopedic · 83d
Cleared Mar 04, 2025
Calibrate Interbody Systems
K243461
Alphatec Spine, Inc.
Orthopedic · 116d
Cleared Mar 04, 2025
Disposable Cytology Brush (AF series)
K241679 · KTI
Alton (Shanghai) Medical Instruments...
Anesthesiology · 266d
Cleared Mar 04, 2025
iPhysio® System
K232383 · NHA
Euroteknika
Dental · 574d
Cleared Mar 03, 2025
Titanium Flexible Geometry FSD Applicator Set (GM11013400)
K243939 · JAQ
Varian Medical Systems, Inc.
Radiology · 73d
Cleared Mar 03, 2025
HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and...
K243881 · KPS
Bracco Diagnostics, Inc.
Radiology · 75d
Cleared Mar 03, 2025
JLK-SDH
K243611 · QAS
JLK, Inc.
Radiology · 101d
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