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
2113–2136 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 03, 2025
Sonosite MT Ultrasound System
K253448 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 32d
Cleared Nov 03, 2025
NightGuard Aire Max
K252698 · LRK
Nightguard Express, LLC
Dental · 68d
Cleared Nov 03, 2025
Electric wheelchair (NSDS-01)
K252671 · ITI
Hebei Dansong Medical Technology Co.,...
Physical Medicine · 70d
Cleared Nov 03, 2025
cobas HCV
K252484 · MZP
Roche Molecular Systems, Inc.
Microbiology · 88d
Cleared Nov 03, 2025
cobas CMV
K252481 · PAB
Roche Molecular Systems, Inc.
Microbiology · 88d
Cleared Nov 03, 2025
Kyphoplasty Balloon Dilatation Catheters
K252458 · HRX
Shanghai Lange Medtech Co., Ltd.
Orthopedic · 90d
Cleared Nov 03, 2025
Midmark Dental Delivery System
K251626 · EIA
Midmark Corporation
Dental · 159d
Cleared Nov 03, 2025
Acorn 3D Software (AC-SEG-4009)
K251532 · LLZ
Mighty Oak Medical
Radiology · 168d
Cleared Nov 03, 2025
ZAP-X Radiosurgery System (ZAP-X)
K250392 · IYE
Zap Surgical Systems, Inc.
Radiology · 264d
Cleared Nov 03, 2025
3mensio Workstation
K250330 · QIH
Pie Medical Imaging BV
Radiology · 271d
Cleared Oct 31, 2025
Hydro Print Premium Fast Set - 454g (1lb) (052037)
K253501 · ELW
Vigodent Ind?stria E Comercio Ltda
Dental · 1d
Cleared Oct 31, 2025
Freedom Metaphyseal Cone Implants (Metaphyseal Cones)
K252777 · MBH
Maxx Orthopedics, Inc.
Orthopedic · 59d
Cleared Oct 31, 2025
Kii Structural Balloon Access System
K252442 · GCJ
Applied Medical Resources Corp.
General & Plastic Surgery · 88d
Cleared Oct 31, 2025
Diode Laser Hair Removal Machine (GLD01)
K252427 · GEX
Sanhe Meditech Co., Ltd.
General & Plastic Surgery · 91d
Cleared Oct 31, 2025
Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator)
K252412 · GEI
Applied Medical Resources Corporation
General & Plastic Surgery · 91d
Cleared Oct 31, 2025
Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))
K252160 · OMB
Persyst Development, LLC
Neurology · 113d
Cleared Oct 31, 2025
Firebird SI Navigation System
K252088 · OLO
Orthofix US, LLC
Orthopedic · 121d
Cleared Oct 31, 2025
Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System
K252074 · IYN
Canon Medical Systems Corporation
Radiology · 121d
Cleared Oct 31, 2025
GREEN
K252060 · HBE
Phasor Health, LLC
Neurology · 122d
Cleared Oct 31, 2025
DESS Dental Smart Solutions
K251547 · NHA
Terrats Medical SL
Dental · 163d
Cleared Oct 31, 2025
Ceribell Instant EEG Headcap (Small: C251, Medium: C252)
K251381 · GXY
Ceribell, Inc.
Neurology · 182d
Cleared Oct 31, 2025
GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model GT-GS100
K251041 · FDS
Actuated Medical, Inc.
Gastroenterology & Urology · 211d
Cleared Oct 31, 2025
Flexible Ureterorenoscope system (Electronic Endoscope Image Processor,...
K250917 · FGB
Shenzhen Sanping Image Technology...
Gastroenterology & Urology · 218d
Cleared Oct 31, 2025
BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus...
K250358 · PCI
Becton, Dickinson and Company
Microbiology · 266d