Search FDA 510(k) Database

6,885 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: Cleared only ×
174,061 results
16537–16560 of 174,061
Cleared Dec 24, 2020
Acute Dual Lumen Hemodialysis Catheter
K200426 · MPB
Health Line International Corporation
Gastroenterology & Urology · 307d
Cleared Dec 24, 2020
UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and...
K203544 · GEX
Lumenis, Ltd.
General & Plastic Surgery · 20d
Cleared Dec 23, 2020
Helix Genetic Health Risk App for late-onset Alzheimer’s disease
K192073 · PTA
Helix Opco, LLC
Immunology · 509d
Cleared Dec 23, 2020
SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube Set
K193670 · KDI
Quanta Dialysis Technologies, Ltd.
Gastroenterology & Urology · 358d
Cleared Dec 23, 2020
Customized Contour Implant
K200610 · FWP
Implantech Associates, Inc.
General & Plastic Surgery · 289d
Cleared Dec 23, 2020
DeRoyal Temperature Monitoring Probe
K200631 · FLL
Deroyal Industries, Inc.
General Hospital · 288d
Cleared Dec 23, 2020
AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE...
K200697 · GXH
AtriCure, Inc.
Neurology · 281d
Cleared Dec 23, 2020
Scrambler Therapy Technology (Model ST-5A)
K201458 · GZJ
Delta International Services &...
Neurology · 205d
Cleared Dec 23, 2020
Plasdent Disposable Barrier Sleeves and Barrier Film
K201604 · PEM
Plasdent Corporation
General & Plastic Surgery · 191d
Cleared Dec 23, 2020
Medical Face mask
K202061 · FXX
Jiangsu Province Jianerkang Medical...
General Hospital · 149d
Cleared Dec 23, 2020
Locking device
K202237 · ODC
Hangzhou AGS MedTech Co., Ltd.
Gastroenterology & Urology · 138d
Cleared Dec 23, 2020
CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal,...
K202320 · OLO
Brainlab AG
Orthopedic · 128d
Cleared Dec 23, 2020
SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging System
K202353 · IZL
Shantou Institute of Ultrasonic...
Radiology · 127d
Cleared Dec 23, 2020
ControlRad Select Model Z
K202431 · OWB
Controlrad, Inc.
Radiology · 120d
Cleared Dec 23, 2020
OmniTom Elite
K202526 · JAK
Neurologica Corporation, A Subsidiary...
Radiology · 113d
Cleared Dec 23, 2020
F3D Corpectomy System
K202637 · MQP
Corelink, LLC
Orthopedic · 103d
Cleared Dec 23, 2020
Affinity
K202882 · KPS
Hermes Medical Solutions AB
Radiology · 86d
Cleared Dec 23, 2020
AltiVate® Anatomic Pegged Glenoid with Markers
K203026 · KWS
Encore Medical, L.P.
Orthopedic · 82d
Cleared Dec 23, 2020
Omnia Medical TiBrid-SA
K203207 · OVD
Omnia Medical, LLC
Orthopedic · 54d
Cleared Dec 23, 2020
LUBi Water Based Personal Lubricant
K203257 · NUC
Boya Biotechnology Co., Ltd.
Obstetrics & Gynecology · 49d
Cleared Dec 23, 2020
WishBone Medical Plate and Screw System
K203467 · HWC
Wishbone Medical, Inc.
Orthopedic · 28d
Cleared Dec 23, 2020
Bridge Occlusion Balloon
K203540 · MJN
Spectranetics, Inc.
Cardiovascular · 20d
Cleared Dec 22, 2020
SoloAsisst II, Voice Control
K200473 · NAY
Aktormed GmbH
General & Plastic Surgery · 300d
Cleared Dec 22, 2020
iSMILE
K200908 · NXC
3D Diagnostix, Inc.
Dental · 260d