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
6529–6552 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 20, 2024
Freedom Peripheral Nerve Stimulator (PNS) System
K233162 · GZF
Curonix
Neurology · 267d
Cleared Jun 20, 2024
Copra Smile, Copra Supreme Hyperion
K233158 · EIH
Whitepeaks Dental Solutions GmbH
Dental · 267d
Cleared Jun 20, 2024
Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT)
K233117 · EBW
Nakanishi, Inc.
Dental · 267d
Cleared Jun 20, 2024
DeepRhythm Platform
K232161 · DPS
Medicalgorithmics S.A.
Cardiovascular · 336d
Cleared Jun 20, 2024
VITEK REVEAL GN AST Assay and VITEK REVEAL AST System
K230675 · SAN
Specific Diagnostics, LLC
Microbiology · 468d
Cleared Jun 19, 2024
EVIS Exera III Gastrointestinal Videoscope GIF-1TH190
K232997 · FDS
Olympus Medical Systems Corporation
Gastroenterology & Urology · 271d
Cleared Jun 18, 2024
Invisalign System
K241412 · NXC
Align Technology, Inc.
Dental · 32d
Cleared Jun 18, 2024
Pen Injector
K240774 · FMF
Wuxi Nest Biotechnology Co., Ltd.
General Hospital · 89d
Cleared Jun 18, 2024
ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and...
K240678 · MBH
Depuy Ireland UC
Orthopedic · 99d
Cleared Jun 18, 2024
IPL Home Use Hair Removal Device (D-1199, D-T099, D-T018, D-T019, D-T003B,...
K240583 · OHT
Shenzhen Beauty Every Moment...
General & Plastic Surgery · 109d
Cleared Jun 18, 2024
Irrisept Antimicrobial Wound Lavage
K240552 · FRO
Irrimax Corporation
General & Plastic Surgery · 111d
Cleared Jun 18, 2024
Bladeless Trocar (E05, E10, E11, E12, ES05, ES10, ES12)
K240196 · GCJ
Yuwonmeditech Co., Ltd.
General & Plastic Surgery · 145d
Cleared Jun 18, 2024
Fitbone Trochanteric
K233867 · HSB
Orthofix Srl
Orthopedic · 195d
Cleared Jun 18, 2024
MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter
K233553 · CAF
Thayer Medical Corporation
Anesthesiology · 225d
Cleared Jun 18, 2024
Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM
K233294 · KNW
Itp Innovative Tomography Products GmbH
General & Plastic Surgery · 263d
Cleared Jun 18, 2024
Ultrasonic Surgical System
K233036 · LFL
Hunan Handlike Minimally Invasive...
General & Plastic Surgery · 267d
Cleared Jun 17, 2024
AllTest Multi-Drug Urine Test Cup
K241428 · NFT
Hangzhou AllTest Biotech Co., Ltd.
Toxicology · 28d
Cleared Jun 17, 2024
Ion 3D
K241416 · MRW
SurGenTec, LLC
Orthopedic · 31d
Cleared Jun 17, 2024
Medical Diode Laser (M2-GK)
K240747 · GEX
Wuhan Pioon Technology Co., Ltd.
General & Plastic Surgery · 90d
Cleared Jun 17, 2024
Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9...
K240684 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 97d
Cleared Jun 17, 2024
VERABAND™
K233987 · LEL
Arbor Medical Innovations, LLC
Neurology · 182d
Cleared Jun 17, 2024
MediOMx
K233331 · LLZ
Pmx, Inc.
Radiology · 262d
Cleared Jun 17, 2024
Molecular Transport Media - MTM
K233324 · QBD
Alb Luz
Microbiology · 262d
Cleared Jun 17, 2024
Robotic Integration Instruments
K233256 · OLO
DePuy Synthes
Orthopedic · 263d