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
5137–5160 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 23, 2024
ARTFX Trauma Bone Plate and Screw System
K242939 · HRS
Artfx Medical
Orthopedic · 89d
Cleared Dec 23, 2024
OsteoFlo HydroFiber
K242797 · MQV
SurGenTec, LLC
Orthopedic · 98d
Cleared Dec 23, 2024
GlassBone Granules
K242782 · MQV
Noraker
Orthopedic · 98d
Cleared Dec 23, 2024
Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min)
K242735 · FRN
Belmont Medical Technologies
General Hospital · 103d
Cleared Dec 23, 2024
NIDO Baby Magnetic Resonance Imaging System
K242573 · LNH
Jiangsu Lici Medical Device Co., Ltd.
Radiology · 116d
Cleared Dec 23, 2024
Aquilion ONE (TSX-308A/3) V1.5
K242403 · JAK
Canon Medical Systems Corporation
Radiology · 132d
Cleared Dec 23, 2024
Angiography Injector
K242143 · DXT
Shandong Int Medical Instruments Co.,...
General Hospital · 154d
Cleared Dec 23, 2024
Bolo Button System
K242091 · HTN
Fusion Orthopedics
Orthopedic · 159d
Cleared Dec 23, 2024
Sofjec (Single use Needle)
K241856 · FMF
Hlb Lifescience Co., Ltd.
General Hospital · 179d
Cleared Dec 23, 2024
Noxturnal Web
K241288 · OLV
Nox Medical Ehf
Neurology · 230d
Cleared Dec 23, 2024
SIMEOX 200 Airway Clearance Device
K241091 · SDT
Inogen, Inc.
Anesthesiology · 245d
Cleared Dec 23, 2024
Electrosurgical Generator (ES-100)
K240975 · GEI
Beijing Taktvoll Technology Co., Ltd.
General & Plastic Surgery · 257d
Cleared Dec 23, 2024
PanopticAI Vital Signs
K240890 · QME
PanopticAI technologies Limited
Cardiovascular · 266d
Cleared Dec 23, 2024
Genadyne DUO NPWT
K233614 · OMP
Genadyne Biotechnologies, Inc.
General & Plastic Surgery · 406d
Cleared Dec 22, 2024
SLT Select Fiber Delivery System and Contact Tips (models: SSRH 8-SMA
K243121 · GEX
Jiangxi Medex Technology Co., Ltd.
General & Plastic Surgery · 83d
Cleared Dec 21, 2024
LGO-Surgical Laser Fibers
K243147 · GEX
Light Guide Optics International , Ltd.
General & Plastic Surgery · 82d
Cleared Dec 21, 2024
IPL Hair Removal Device (DE03A-W, DE03A-P, DE03A-V, DE03A-G, DE03B-W,...
K243085 · OHT
Zhuzhou Goldenhot Medical Technology...
General & Plastic Surgery · 82d
Cleared Dec 20, 2024
HPR Cordless Hygiene Handpiece
K243911 · EKX
Handpiece Headquarters
Dental · 1d
Cleared Dec 20, 2024
BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack)...
K243759 · PEN
Biofire Diagnostics, LLC
Microbiology · 14d
Cleared Dec 20, 2024
InkSpace Imaging Small Body Array
K243675 · MOS
Inkspace Imaging, Inc.
Radiology · 23d
Cleared Dec 20, 2024
ExcelsiusGPS® Instruments
K243671 · OLO
Globus Medical, Inc.
Orthopedic · 23d
Cleared Dec 20, 2024
Momcozy Wearable Breast Pump (BP311)
K243629 · HGX
Shenzhen Root Innovation Technology...
Obstetrics & Gynecology · 25d
Cleared Dec 20, 2024
Moda-flx Hemodialysis System™ Cartridge (102121-001 )
K243607 · FJK
Diality, Inc.
Gastroenterology & Urology · 29d
Cleared Dec 20, 2024
Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System,...
K243308 · HRS
Bonebridge AG
Orthopedic · 60d