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
2953–2976 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 30, 2025
Stabilis SA Cervical Stand-Alone System (Various PNs)
K251735 · OVE
Acuity Surgical Devices, LLC
Orthopedic · 54d
Cleared Jul 30, 2025
TENS and EMS Unit
K251706 · NGX
Changsha Anxiang Medical Technology...
Physical Medicine · 57d
Cleared Jul 30, 2025
Tyber Medical Distal Radius Plating System
K251361 · HRS
Tyber Medical, LLC
Orthopedic · 90d
Cleared Jul 30, 2025
Sterile Nitrile Powder Free Examination Glove Tested for Use with...
K251319 · LZA
Hartalega NGC Sdn. Bhd.
General Hospital · 92d
Cleared Jul 30, 2025
EnSite™ X EP System
K251234 · DQK
Abbott Medical
Cardiovascular · 99d
Cleared Jul 30, 2025
Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)
K251076 · GEX
Shenzhen Lifotronic Technology Co., Ltd.
General & Plastic Surgery · 113d
Cleared Jul 30, 2025
CORUS™ Navigation System-GX
K251060 · OLO
Providence Medical Technology, Inc.
Orthopedic · 117d
Cleared Jul 30, 2025
Intraosseous Infusion Needles
K250724 · FMI
Spectrum Vascular
General Hospital · 142d
Cleared Jul 30, 2025
TSK Syringe
K250127 · QNQ
Tsk Laboratory, Japan
General Hospital · 194d
Cleared Jul 30, 2025
ArteVu
K244007 · DXN
Cardio Ring Technologies, Inc. Taiwan...
Cardiovascular · 216d
Cleared Jul 30, 2025
Voxel Dosimetry (00859873006226)
K243919 · QIH
Hermes Medical Solutions AB
Radiology · 222d
Cleared Jul 30, 2025
Micro Catheter
K243534 · KRA
Suzhou Zenith Vascular SciTech Limited
Neurology · 257d
Cleared Jul 30, 2025
P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)
K242855 · LPL
E.O.S Co., Ltd.
Ophthalmic · 313d
Cleared Jul 30, 2025
SpineSite Endoscope System
K241990 · HRX
Hydrocision, Inc.
Orthopedic · 387d
Cleared Jul 29, 2025
Single Use Aspiration Needle (NA-201SX-4021)
K251664 · KTI
Olympus Medical Systems Corporation
Anesthesiology · 60d
Cleared Jul 29, 2025
Cios Spin
K251523 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 74d
Cleared Jul 29, 2025
Sleepiz One+ (2.5)
K251364 · DRT
Sleepiz AG
Cardiovascular · 89d
Cleared Jul 29, 2025
BD Plastipak™ Syringe
K251350 · FMF
Becton, Dickinson and Company
General Hospital · 90d
Cleared Jul 29, 2025
SImmetry+ System
K250647 · OUR
Sivantage
Orthopedic · 147d
Cleared Jul 29, 2025
da Vinci Surgical System, IS5000
K250442 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 165d
Cleared Jul 29, 2025
MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)
K250356 · DSI
Infobionic, Inc.
Cardiovascular · 172d
Cleared Jul 29, 2025
Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)
K250179 · MHX
Edan Instruments, Inc.
Cardiovascular · 188d
Cleared Jul 29, 2025
PRORAD ATLAS ULTRAPORTABLE
K243473 · IZL
Prognosys Medical Systems Private...
Radiology · 263d
Cleared Jul 29, 2025
Forcyte Autograft Harvest Kit
K243407 · KNW
Forcyte Medical, LLC
Orthopedic · 270d