Search FDA 510(k) Devices

5,483 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: 2023–2023 ×
3,347 results
2017–2040 of 3,347
Cleared Jun 06, 2023
ARC Intensive Care Information System (ARC System)
K220117 · MWI
Ordinatrum Solutions
Cardiovascular · 508d
Cleared Jun 06, 2023
Diode laser therapy device
K212734 · GEX
Triangel Rsd Limited
General & Plastic Surgery · 645d
Cleared Jun 06, 2023
Diode laser therapy device
K212733 · GEX
Beijing Star New Tech Co., Ltd.
General & Plastic Surgery · 645d
Not Cleared Jun 06, 2023
Cue COVID-19 Molecular Test
DEN220028 · QWB
Cue Health, Inc.
Microbiology · 400d
Cleared Jun 05, 2023
Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF
K231348 · QSE
Roche Diagnostics
Immunology · 27d
Cleared Jun 05, 2023
Zhenjiang Assure Mechanical Wheelchair,model:K1
K231320 · IOR
Zhenjiang Assure Medical Equipment...
Physical Medicine · 28d
Cleared Jun 05, 2023
Alinity i Total ß-hCG Reagent Kit, GLP systems Track
K230937 · DHA
Abbott Laboratories
Chemistry · 63d
Cleared Jun 05, 2023
SPY Portable Handheld Imaging (SPY-PHI) System
K230727 · IZI
Novadaq Technologies Ulc (A Part of...
General & Plastic Surgery · 81d
Cleared Jun 05, 2023
APOLLO ADVANTAGE Nitrile Examination Gloves
K230633 · LZA
Dell Corning Corporation
General Hospital · 90d
Cleared Jun 05, 2023
ArtiSential Laparoscopic Instruments-Electrodes
K230498 · GEI
Livsmed, Inc.
General & Plastic Surgery · 101d
Cleared Jun 05, 2023
DynaFlex Clear Brackets & Buttons
K230225 · NJM
Dyna Flex
Dental · 129d
Cleared Jun 05, 2023
FX V135(TM) Shoulder Prosthesis
K223801 · PHX
Fx Shoulder USA, Inc.
Orthopedic · 168d
Cleared Jun 05, 2023
HandX™ Self-Righting Needle Holder
K223718 · GCJ
Human Xtensions , Ltd.
General & Plastic Surgery · 175d
Cleared Jun 05, 2023
Fluido Compact Blood and Fluid Warming System
K211618 · LGZ
The Surgical Company International B.V.
General Hospital · 740d
Cleared Jun 04, 2023
Stella
K221752 · DZE
Shinhung Mst Co., Ltd.
Dental · 353d
Cleared Jun 02, 2023
Fine Osteotomy™
K231314 · PBF
Bodycad Laboratories, Inc.
Orthopedic · 28d
Cleared Jun 02, 2023
CPS Direct™ Universal slittable outer guide catheter (DS2C029)
K231311 · DQY
Abbott Medical
Cardiovascular · 28d
Cleared Jun 02, 2023
SCAR 3
K231309 · GEX
El.En Electroinc Engineering Spa
General & Plastic Surgery · 28d
Cleared Jun 02, 2023
APTUS® 3.5 TriLock Straight Plates
K230971 · HRS
Medartis AG
Orthopedic · 58d
Cleared Jun 02, 2023
Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS)...
K230952 · JWH
Howmedica Osteonics Corp., Dba...
Orthopedic · 59d
Cleared Jun 02, 2023
Anatomic PEEK™ Cervical Fusion System with Nanotechnology
K230936 · ODP
Nanovis, LLC
Orthopedic · 60d
Cleared Jun 02, 2023
Titanium Turbine
K230888 · EFB
Nakanishi, Inc.
Dental · 63d
Cleared Jun 02, 2023
Pen Needle
K230635 · FMI
Jiangsu Caina Medical Co.,Ltd
General Hospital · 87d
Cleared Jun 02, 2023
Huma RPM (RPM)
K230214 · MWI
Medopad, Inc.
Cardiovascular · 127d