Search FDA 510(k) Devices

5,400 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: 2025–2025 ×
3,225 results
481–504 of 3,225
Cleared Nov 04, 2025
Voyant® Open Fusion Device (EB240/Open Fusion)
K252740 · GEI
Applied Medical Resources Corp.
General & Plastic Surgery · 68d
Cleared Nov 04, 2025
GMReis Suture Anchors
K252664 · MBI
GM Dos Reis Industria e Comercio Ltda.
Orthopedic · 74d
Cleared Nov 04, 2025
MedCAD® AccuStride™ System
K251709 · PBF
Medcad
Orthopedic · 154d
Cleared Nov 04, 2025
VXvue
K251410 · LLZ
Vieworks Co., Ltd.
Radiology · 181d
Cleared Nov 04, 2025
Tamburo Thulium Fiber Laser System
K251303 · GEX
Menovex Medical Technology (Shenzhen)...
General & Plastic Surgery · 190d
Cleared Nov 04, 2025
Merit Syringe
K250853 · FMF
Merit Medical Systems, Inc.
General Hospital · 228d
Cleared Nov 04, 2025
Flexx Junior (FLX-J00, FLX-J50)
K250576 · IOR
Karma Mobility Co, Ltd.
Physical Medicine · 250d
Cleared Nov 04, 2025
Cios Select
K250241 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 281d
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