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
11377–11400 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 18, 2023
Anatomic Bone Plate
K221088 · HRS
Double Medical Technology, Inc.
Orthopedic · 280d
Cleared Jan 18, 2023
Uni-FuZe-C Bone Strip
K221726 · MQV
Zavation Medical Products, LLC
Orthopedic · 218d
Cleared Jan 18, 2023
Transit-Pellets
K222000 · FFX
Medifactia AB
Gastroenterology & Urology · 195d
Cleared Jan 18, 2023
TruPlan Computed Tomography (CT) Imaging Software
K222593 · LLZ
Circle Cardiovascular Imaging, Inc.
Radiology · 145d
Cleared Jan 18, 2023
MOLLI 2
K223107 · NEU
Molli Surgical, Inc.
General & Plastic Surgery · 110d
Cleared Jan 18, 2023
eXciteOSA without remote control (3000)
K223446 · QNO
Signifier Medical Technologies, Ltd.
Dental · 64d
Cleared Jan 18, 2023
PercuNav Image Fusion and Interventional Navigation System
K223804 · JAK
Philips Ultrasound, LLC
Radiology · 30d
Cleared Jan 18, 2023
SI-Cure Sacroiliac Joint Fusion System
K223819 · OUR
Alevio, LLC
Orthopedic · 28d
Cleared Jan 17, 2023
HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch)
K213655 · IPF
Hilltek, LLC
Physical Medicine · 424d
Cleared Jan 17, 2023
Elucis
K220649 · LLZ
Realize Medical, Inc.
Radiology · 316d
Cleared Jan 17, 2023
Disposable Endoscope Valve Sets
K220884 · ODC
Sml Med-Tech Solutions Limited
Gastroenterology & Urology · 295d
Cleared Jan 17, 2023
Ag Foam Dressing Non-Adhesive (OTC)
K221754 · FRO
Winner Medical Co., Ltd.
General & Plastic Surgery · 215d
Cleared Jan 17, 2023
Halcyon, Ethos Radiotherapy System
K222941 · IYE
Varian Medical Systems, Inc.
Radiology · 113d
Cleared Jan 17, 2023
Portable X-ray System
K223010 · EHD
Iray Technology Taicang , Ltd.
Radiology · 110d
Cleared Jan 17, 2023
Plasma IQ
K223222 · GEI
Neauvia North America, Inc.
General & Plastic Surgery · 92d
Cleared Jan 17, 2023
hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS
K223794 · OAS
Cefla S.C.
Radiology · 29d
Cleared Jan 17, 2023
FairFix QT Adjustable Button
K223795 · MBI
Medacta International S.A.
Orthopedic · 29d
Cleared Jan 17, 2023
MIM – Additional Tracers
K223800 · LLZ
Mim Software, Inc.
Radiology · 29d
Cleared Jan 13, 2023
Spectricept Skin and Wound Cleanser
K213514 · FRO
Spectrum Antimicrobials, Inc....
General & Plastic Surgery · 437d
Cleared Jan 13, 2023
Silk’n Toothwave
K214078 · QMJ
Home Skinovations , Ltd.
Dental · 382d
Cleared Jan 13, 2023
SignaSure Dual Mobility System
K220495 · MEH
Signature Orthopaedics Pty, Ltd.
Orthopedic · 325d
Cleared Jan 13, 2023
Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F,...
K221020 · EZL
Potrero Medical, Inc.
Gastroenterology & Urology · 282d
Cleared Jan 13, 2023
Scivita 4KINSIGHT ICG Imaging System
K221252 · GCJ
Scivita Medical Technology Co., Ltd.
General & Plastic Surgery · 256d
Cleared Jan 13, 2023
S-Mono
K221317 · DZE
Shinhung Mst Co., Ltd.
Dental · 252d