Search FDA 510(k) Devices

5,442 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: 2024–2024 ×
3,129 results
1465–1488 of 3,129
Cleared Jul 18, 2024
Electric Wheelchair (MP201C)
K241463 · ITI
Suzhou Master Machinery Manufacturing...
Physical Medicine · 56d
Cleared Jul 18, 2024
Juliet® Ti LL Lumbar Interbody Device
K241321 · OVD
Spineart SA
Orthopedic · 69d
Cleared Jul 18, 2024
Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay
K241240 · QOF
Hologic, Inc.
Microbiology · 76d
Cleared Jul 18, 2024
Quantum Perfusion Hybrid System
K241206 · DTN
Spectrum Medical S.R.L.
Cardiovascular · 79d
Cleared Jul 18, 2024
HardyDisk AST Cefiderocol 30µg (FDC30)
K241060 · JTN
Hardy Diagnostics
Microbiology · 91d
Cleared Jul 18, 2024
B4C System - Addition of new sensor model (BcSs-PICNIW-2000)
K240821 · GWM
Braincare Desenvolvimento E Inova??o...
Neurology · 115d
Cleared Jul 18, 2024
Surgical Drive System (Model: ES70, ES90, E8)
K240340 · DZI
Guangdong Jinme Medical Technology...
Dental · 164d
Cleared Jul 18, 2024
CEFALY Connected - OTC, CEFALY Connected - Rx
K234029 · PCC
Cefaly Technology
Neurology · 211d
Cleared Jul 18, 2024
ICHOR 7F Embolectomy System (ICH-7F)
K233917 · QEW
Ichor
Cardiovascular · 219d
Cleared Jul 18, 2024
Papacarie Duo
K233768 · LBH
Elevate Oral Care
Dental · 237d
Cleared Jul 18, 2024
Equinoxe® Central Screw Baseplate System
K233482 · PHX
Exactech, Inc.
Orthopedic · 266d
Cleared Jul 18, 2024
SOLID CLIP™ Single Use Clip Applier
K221495 · FZP
Medscope Biotech Co., Ltd.
General & Plastic Surgery · 787d
Cleared Jul 18, 2024
Field Shield Wound Dressing
K212521 · FRO
Kericure, Inc.
General & Plastic Surgery · 1073d
Cleared Jul 17, 2024
Stable-C Interbody System
K241467 · OVE
Nexus Spine, LLC
Orthopedic · 55d
Cleared Jul 17, 2024
sagAlign Lumbar Cage System (Various PNs)
K241413 · MAX
Acuity Surgical Devices, LLC
Orthopedic · 61d
Cleared Jul 17, 2024
MICSI-RMT
K241121 · LLZ
Microstructure Imaging, Inc.
Radiology · 85d
Cleared Jul 17, 2024
3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2)
K241081 · OBO
Topcon Corporation
Ophthalmic · 89d
Cleared Jul 17, 2024
Rayvolve
K240845 · QBS
Azmed Sas
Radiology · 112d
Cleared Jul 17, 2024
Vitrea Software Package, VSTP-002A V2.0
K240705 · LLZ
Canon Medical Systems Corporation
Radiology · 125d
Cleared Jul 17, 2024
S.I.N. Dental Implant System
K240609 · DZE
S.I.N. ? Sistema DE Implante Nacional...
Dental · 135d
Cleared Jul 17, 2024
Sonata Transcervical Fibroid Ablation System 2.2
K240503 · KNF
Gynesonics, Inc.
Obstetrics & Gynecology · 147d
Cleared Jul 17, 2024
ACIST RXi System (016616)
K233904 · DXO
Acist Medical Systems, Inc.
Cardiovascular · 219d
Cleared Jul 16, 2024
SAFElife™ Fentanyl Urine Home Test (Cassette)
K241741 · NGL
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 29d
Cleared Jul 16, 2024
Finesse Injectable™ PTA Balloon Dilatation Catheter
K241740 · LIT
Summa Therapeutics
Cardiovascular · 29d