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
6097–6120 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 09, 2024
CHOLESTEROL
K232404 · CHH
Medicon Hellas S.A
Chemistry · 365d
Cleared Aug 09, 2024
MEDIDIODE
K231950 · GEX
Medicreations, LLC
General & Plastic Surgery · 406d
Cleared Aug 09, 2024
The Trust
K222688 · EKX
Genoss Co., Ltd.
Dental · 703d
Cleared Aug 08, 2024
360CAS Knee
K242009 · OLO
Kico Knee Innovation Company Pty, Ltd.
Orthopedic · 29d
Cleared Aug 08, 2024
Omni Legend
K241665 · KPS
Ge Medical Systems Israel, Functional...
Radiology · 59d
Cleared Aug 08, 2024
SynthVISION 1.0.0
K240724 · LLZ
Synthesis Health Intelligence, Inc.
Radiology · 143d
Cleared Aug 08, 2024
Masimo W1
K240229 · DPS
Masimo Corporation
Cardiovascular · 192d
Cleared Aug 08, 2024
F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility...
K234058 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 230d
Cleared Aug 08, 2024
OdneClean
K233844 · ELC
Odne AG
Dental · 248d
Cleared Aug 08, 2024
i2Contour
K233822 · QIH
Mrimath, LLC
Radiology · 251d
Cleared Aug 08, 2024
Luminopia
K233720 · QQU
Luminopia, Inc.
Ophthalmic · 261d
Cleared Aug 08, 2024
SMARxT Tubing and Connectors
K233702 · DWE
LivaNova USA, Inc.
Cardiovascular · 265d
Cleared Aug 08, 2024
Illusion Aligner Pro: Illusion Aligner FLX
K233356 · NXC
Laxmi Dental Export Pvt., Ltd.
Dental · 314d
Cleared Aug 08, 2024
HipXpert and HipInsight System
K233315 · OSF
Surgical Planning Associates, Inc.
Orthopedic · 314d
Cleared Aug 08, 2024
SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499)
K233312 · QZB
Aktormed GmbH
General & Plastic Surgery · 314d
Cleared Aug 08, 2024
GR Resin System MSI
K231775 · MQC
Pro3Dure Medical
Dental · 419d
Cleared Aug 07, 2024
SofWave System
K241685 · NGX
Sofwave Medical, Ltd.
Neurology · 57d
Cleared Aug 07, 2024
SPINEART Navigation Instrument System
K241644 · OLO
Spineart SA
Orthopedic · 61d
Cleared Aug 07, 2024
Stellar Imaging System
K241530 · GCJ
Guangdong Optomedic Technologies, Inc.
General & Plastic Surgery · 69d
Cleared Aug 07, 2024
Ultra RapidWarm™ Blast
K240605 · MQL
Vitrolife Sweden AB
Obstetrics & Gynecology · 156d
Cleared Aug 07, 2024
HALYARD* SMART-FOLD* Sterilization Wrap (H450)
K240330 · FRG
O&M Halyard, Inc.
General Hospital · 184d
Cleared Aug 07, 2024
Electric Wheelchair (JLE-W01A-2023)
K240255 · ITI
Zhejiang Jianrui Technology Company...
Physical Medicine · 189d
Cleared Aug 07, 2024
ADVIA Centaur EBV-VCA IgM
K233606 · LSE
Biokit, S.A.
Microbiology · 272d
Cleared Aug 07, 2024
ADVIA Centaur EBV-EBNA IgG
K233605 · LLM
Biokit, S.A.
Microbiology · 272d