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
3529–3552 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 30, 2025
Opulus™ Lymphoma Precision
K243863 · QIH
Roche Molecular Systems, Inc.
Radiology · 164d
Cleared May 30, 2025
DentalJect
K243654 · MLY
Vapocoolshot, Inc.
Dental · 185d
Cleared May 30, 2025
Dynamic TiBase
K243530 · NHA
Talladium Espa?a, SL
Dental · 197d
Cleared May 30, 2025
ViVi® Toga Premium
K243522 · FYA
Thi Total Healthcare Innovation GmbH
General Hospital · 197d
Cleared May 30, 2025
5008X Hemodialysis System
K243505 · KDI
Fresenius Medical Care Renal...
Gastroenterology & Urology · 199d
Cleared May 30, 2025
Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804)
K243010 · FXX
Owens & Minor (O&M) Halyard, Inc.
General Hospital · 246d
Cleared May 30, 2025
AudaxCeph Cephalogram Analysis Software
K243005 · QIH
Audax D.O.O.
Radiology · 246d
Cleared May 30, 2025
XBody Go USA, XBody Pro USA
K242926 · NGX
Xbody Hungary Kft.
Physical Medicine · 248d
Cleared May 30, 2025
LensHooke X3 PRO Semen Quality Analyzer
K242830 · POV
Bonraybio Co., Ltd.
Hematology · 253d
Cleared May 30, 2025
ARIX Pectus Bar System
K242751 · HRS
Jeil Medical Corporation
Orthopedic · 260d
Cleared May 30, 2025
Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and...
K242725 · HGX
Ningbo Youhe Electrical Appliance...
Obstetrics & Gynecology · 262d
Cleared May 30, 2025
FertiCult Flushing medium
K242640 · MQL
Fertipro NV
Obstetrics & Gynecology · 269d
Cleared May 30, 2025
Endoscopic Distal Attachment (AF-D series)
K242635 · FDS
Alton (Shanghai) Medical Instruments...
Gastroenterology & Urology · 269d
Cleared May 30, 2025
OHC COVID-19 Antigen Self Test
K241313 · QYT
Osang, LLC
Microbiology · 386d
Cleared May 29, 2025
ProSeal™ Bag Spike with Additive Port (423370ST, 423370)
K251340 · ONB
Epic Medical Pte. , Ltd.
General Hospital · 29d
Cleared May 29, 2025
VersaCross Connect™ Transseptal Dilator
K251325 · DRE
Baylis Medical Company, Inc.
Cardiovascular · 30d
Cleared May 29, 2025
Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation...
K251315 · OLO
Remex Medical Corp.
Orthopedic · 30d
Cleared May 29, 2025
Radius VSM and Accessories
K250757 · MHX
Masimo Corporation
Cardiovascular · 78d
Cleared May 29, 2025
CERABIEN MiLai
K250673 · EIH
Kuraray Noritake Dental, Inc.
Dental · 84d
Cleared May 29, 2025
Dental Barrier and Sleeves
K250606 · PEM
Yueying Medical Instruments...
Dental · 90d
Cleared May 29, 2025
Voluson™ Performance 16
K250543 · IYN
GE Medical Systems Ultrasound and...
Radiology · 94d
Cleared May 29, 2025
Visualase V2 MRI-guided Laser Ablation System (9736422)
K250307 · ONO
Medtronic Navigation
Neurology · 115d
Cleared May 29, 2025
Baha 7 Sound Processor
K250215 · LXB
Cochlear
Ear, Nose, Throat · 125d
Cleared May 29, 2025
NEUROMARK System (NMK00301)
K250048 · GEI
Neurent Medical , Ltd.
Ear, Nose, Throat · 139d