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
5065–5088 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 07, 2025
COREPASS Modular Microcatheter (FLEX)
K242588 · DQY
OrbusNeich Medical (Shenzhen) Co., Ltd.
Cardiovascular · 130d
Cleared Jan 07, 2025
GXR-Series Diagnostic X-Ray System
K242019 · KPR
DRGEM Corporation
Radiology · 181d
Cleared Jan 07, 2025
ApolloHipX (THR.SS.0001)
K241808 · LLZ
Corin U.S.A. Limited
Radiology · 200d
Cleared Jan 07, 2025
GlutenID Celiac Genetic Health Risk Test
K241456 · PTA
Targeted Genomics, LLC
Immunology · 230d
Cleared Jan 07, 2025
uCT 780
K241079 · JAK
Shanghai United Imaging Healthcare...
Radiology · 263d
Cleared Jan 06, 2025
TMINI Miniature Robotic System
K243481 · OLO
THINK Surgical, Inc.
Orthopedic · 59d
Cleared Jan 06, 2025
Conformity Stem Extension Line, #0
K243466 · LZO
United Orthopedic Corporation
Orthopedic · 59d
Cleared Jan 06, 2025
WHILL Model R
K242760 · INI
Whill, Inc.
Physical Medicine · 116d
Cleared Jan 06, 2025
SD TL Implant System
K242753 · DZE
Arum Dentistry Co., Ltd.
Dental · 116d
Cleared Jan 06, 2025
Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E))
K242499 · KPR
Shenzhen?Sontu?Medical?Imaging?Equipm...
Radiology · 137d
Cleared Jan 06, 2025
Soteria E-View
K242488 · JAA
Omega Medical Imaging, LLC
Radiology · 138d
Cleared Jan 06, 2025
Mobility Scooter (YL-09B, YL-07)
K242139 · INI
Yongkang Yile Vehicle Co., Ltd.
Neurology · 168d
Cleared Jan 06, 2025
Brainomix 360 e-CTA
K242123 · LLZ
Brainomix Limited
Radiology · 171d
Cleared Jan 06, 2025
DermiSphere Dermal Template
K241904 · KGN
Fesariustherapeutics, Inc.
General & Plastic Surgery · 189d
Cleared Jan 03, 2025
Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™...
K250015 · DYH
Ormco Corporation
Dental · 1d
Cleared Jan 03, 2025
Inbella RF System
K243737 · GEI
Inbella Medical, Inc.
General & Plastic Surgery · 30d
Cleared Jan 03, 2025
JLK-ICH
K243363 · QAS
JLK, Inc.
Radiology · 66d
Cleared Jan 03, 2025
Synapsys VHIT
K242726 · GWN
Inventis S.R.L.
Ear, Nose, Throat · 115d
Cleared Jan 03, 2025
EVOLVE Nitric Oxide Delivery System
K242578 · MRN
Mallinckrodt Manufacturing, LLC
Anesthesiology · 127d
Cleared Jan 03, 2025
INNOVISION-EXII
K242119 · KPR
Dk Medical System
Radiology · 168d
Cleared Jan 03, 2025
PENTAX Medical Video Colonoscope (EC38-i20cWL)
K242110 · FDF
Pentax of America, Inc.
Gastroenterology & Urology · 168d
Cleared Jan 03, 2025
syngo.CT Dual Energy
K241757 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 199d
Cleared Jan 03, 2025
Clarify DL
K241350 · LLZ
Ge Medical Systems Israel, Functional...
Radiology · 235d
Cleared Jan 03, 2025
Elemental Granulate
K241283 · OLR
Zinkh NV
Dental · 241d