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
12889–12912 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 29, 2022
Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C)
K221251 · NUH
Guangzhou Huakai Electronic...
Neurology · 88d
Cleared Jul 29, 2022
Dexcom G6 Continuous Glucose Monitoring (CGM) System, Dexcom G6 Glucose...
K221259 · QBJ
Dexcom, Inc.
Chemistry · 88d
Cleared Jul 29, 2022
EleGARD
K221901 · FOA
Advancedcpr Solutions, LLC
General Hospital · 29d
Cleared Jul 29, 2022
RhinAer® Stylus (FG1393)
K221907 · GEI
Aerin Medical, Inc.
Ear, Nose, Throat · 29d
Cleared Jul 29, 2022
Catapult Guide Sheath
K221914 · DYB
Contract Medical International, GmbH
Cardiovascular · 29d
Cleared Jul 28, 2022
MagXtract Collection Tube
K212113 · QBD
Magbio Genomics, Inc.
Microbiology · 386d
Cleared Jul 28, 2022
cvi42 Auto Imaging Software Application
K213998 · QIH
Circle Cardiovascular Imaging, Inc.
Radiology · 219d
Cleared Jul 28, 2022
BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel
K214122 · PCI
Becton, Dickinson and Company
Microbiology · 210d
Cleared Jul 28, 2022
Single Use Cytology Brush
K220063 · FDX
Zhejiang Chuangxiang Medical...
Gastroenterology & Urology · 199d
Cleared Jul 28, 2022
TRON
K221230 · OWB
Xoran Technologies, LLC
Radiology · 90d
Cleared Jul 28, 2022
neXus Ultrasonic Surgical Aspirator System
K221235 · LFL
Misonix, Inc.
General & Plastic Surgery · 90d
Cleared Jul 28, 2022
OsteoCentric Spine MIS Pedicle Fastener System
K221332 · NKB
OsteoCentric Technologies
Orthopedic · 80d
Cleared Jul 28, 2022
Gastrointestinal Boundary Identifier (GIBI HD)
K221898 · KNT
Reshape Lifesciences
Gastroenterology & Urology · 28d
Cleared Jul 28, 2022
INERTIA CONNEXX Modular Pedicle Screw System
K221905 · NKB
Nexxt Spine, LLC
Orthopedic · 28d
Cleared Jul 28, 2022
Trinias
K221922 · OWB
Shimadzu Corporation Medical Systems...
Radiology · 27d
Cleared Jul 28, 2022
Swoop Portable MR Imaging System
K221923 · LNH
Hyperfine, Inc.
Radiology · 27d
Cleared Jul 28, 2022
Beamer AVEO FILTER INTEGRATED ARGON PROBE 1.8mm x 160 cm, Beamer AVEO FILTER...
K221945 · GEI
Conmed Corporation
General & Plastic Surgery · 23d
Cleared Jul 28, 2022
EXALT Model B Single-Use Bronchoscope
K222014 · EOQ
Boston Scientific Corporation
Ear, Nose, Throat · 20d
Cleared Jul 28, 2022
Biotres
K222017 · MWJ
Biotricity
Cardiovascular · 20d
Cleared Jul 27, 2022
DeepRhythmAI
K210822 · DQK
Medicalgorithmics S.A.
Cardiovascular · 495d
Cleared Jul 27, 2022
EliA Ro52, EliA Ro60
K210902 · LKJ
Phadia AB
Immunology · 488d
Cleared Jul 27, 2022
KeriFlex® MCP and PIP Finger Joint Prostheses
K211385 · KYJ
Keri Medical SA
Orthopedic · 449d
Cleared Jul 27, 2022
TransLoc 3D
K211496 · OUR
Foundation Fusion Solutions, LLC (Dba...
Orthopedic · 440d
Cleared Jul 27, 2022
Dornier Thulio
K213252 · GEX
Dornier Medtech America, Inc.
Gastroenterology & Urology · 300d