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
9097–9120 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Aug 30, 2023
Ventrax™ Delivery System (VTR851)
K231246 · DQY
Merit Medical Systems, Inc.
Cardiovascular · 121d
Cleared Aug 30, 2023
Enzyme Packed Cartridge - RELiZORB
K231156 · PLQ
Alcresta Therapeutics, Inc.
Gastroenterology & Urology · 128d
Cleared Aug 30, 2023
Phoenix Contact Lens Case - dome top flat pack (CL-01)
K231123 · LRX
Phoenix Innovative Healthcare...
Ophthalmic · 132d
Cleared Aug 30, 2023
AlphaVent Suture Anchors
K231093 · MBI
Stryker Endoscopy
Orthopedic · 134d
Cleared Aug 30, 2023
AquaBeam Robotic System
K231024 · PZP
Procept Biorobotics, Corporation
Gastroenterology & Urology · 141d
Cleared Aug 30, 2023
Arrow Non-Stimulating SnapLock Adapter (K-05520-005C)
K230603 · BSO
Teleflex Medical
Anesthesiology · 180d
Cleared Aug 30, 2023
Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR
K230355 · LNH
Canon Medical Systems Corporation
Radiology · 202d
Cleared Aug 30, 2023
Mick Valencia Applicator Set
K230155 · JAQ
Mick Radio-Nuclear Instruments, Inc.
Radiology · 223d
Cleared Aug 30, 2023
Silk'n Titan Allways
K230013 · PAY
Silk'N Beauty , Ltd.
General & Plastic Surgery · 239d
Cleared Aug 30, 2023
Nexis® compressive screws
K223468 · HWC
Novastep
Orthopedic · 286d
Cleared Aug 30, 2023
Ochsner Connected Inhaler Sensor
K223367 · CAF
Ochsner Clinic Foundation
Anesthesiology · 299d