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
9361–9384 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 31, 2023
RAYSCAN a-Expert3D
K232287 · OAS
Ray Co., Ltd.
Radiology · 30d
Cleared Aug 31, 2023
BioSieve™ Marijuana Test Panel 50
K231978 · NFW
Vivachek Biotech (Hangzhou) Co., Ltd.
Toxicology · 59d
Cleared Aug 31, 2023
OSPREY Closed IV Catheter System (OspreyV2)
K231626 · FOZ
Skydance Vascular, Inc.
General Hospital · 90d
Cleared Aug 31, 2023
ZEUS IFA(TM) nDNA Test System, ZEUS dIFine
K231616 · KTL
Zeus Scientific
Immunology · 90d
Cleared Aug 31, 2023
HOLO Portal™ Surgical Guidance System
K231611 · SBF
Surgalign Spine Technologies
Orthopedic · 90d
Cleared Aug 31, 2023
The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution...
K231433 · NGZ
Thermo Fisher Scientific
Microbiology · 106d
Cleared Aug 31, 2023
Ancora-SB
K231323 · FDA
Aspero Medical, Inc.
Gastroenterology & Urology · 115d
Cleared Aug 31, 2023
Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use...
K230578 · KGO
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 183d
Cleared Aug 31, 2023
EL27-Compact
K230488 · FFK
Walz Elektronik GmbH
Gastroenterology & Urology · 189d
Cleared Aug 31, 2023
23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for...
K223597 · QAZ
23AndMe, Inc.
Pathology · 272d
Cleared Aug 31, 2023
Little Wave Arc
K223533 · LBE
Ki Mobility, LLC
Physical Medicine · 281d
Cleared Aug 31, 2023
Little Wave Clik, Rogue XP, Little Wave XP, Spark
K223527 · IOR
Ki Mobility, LLC
Physical Medicine · 281d
Cleared Aug 31, 2023
BD Kiestra IdentifA
K222563 · QQV
Becton, Dickinson and Company
Microbiology · 372d
Cleared Aug 31, 2023
Q21
K221959 · GWQ
Neurofield, Inc.
Neurology · 422d
Cleared Aug 31, 2023
MedicloseTM System
K213271 · OCW
Health Value Creation B.V., Trading...
General & Plastic Surgery · 700d
Cleared Aug 30, 2023
AC3™ Series IABP
K232343 · DSP
Arrow International, LLC
Cardiovascular · 26d
Cleared Aug 30, 2023
StealthFix Intraosseous Fixation System
K232324 · JDR
Medartis, Inc.
Orthopedic · 27d
Cleared Aug 30, 2023
LAA Exclusion System
K232295 · PZX
Syntheon, LLC
Cardiovascular · 29d
Cleared Aug 30, 2023
Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or...
K231988 · JWY
Thermo Fisher Scientific
Microbiology · 56d
Cleared Aug 30, 2023
NIBPCuff
K231961 · DXQ
Shenzhen Sino-K Medical Technology...
Cardiovascular · 58d
Cleared Aug 30, 2023
Brainomix 360 e-MRI
K231656 · LLZ
Brainomix Limited
Radiology · 84d
Cleared Aug 30, 2023
NIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35)
K231580 · ETN
Medtronic Xomed, Inc.
Ear, Nose, Throat · 91d
Cleared Aug 30, 2023
S-Patch Ex Wearable ECG Patch
K231289 · DSH
Wellysis Corp.
Cardiovascular · 118d
Cleared Aug 30, 2023
SmartCardia 7L Platform
K231276 · DSI
Smartcardia SA
Cardiovascular · 120d