Search FDA 510(k) Database

6,588 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
10489–10512 of 174,061
Cleared Dec 13, 2022
Surgical Face Mask
K222651 · FXX
Xiantao Sanda Industrial Co., Ltd.
General Hospital · 103d
Cleared Dec 13, 2022
Conductive Gel
K222770 · GYB
Top-Rank Health Care Co., Ltd.
Neurology · 90d
Cleared Dec 13, 2022
Quantra QPlus System
K223433 · QFR
Hemosonics, LLC
Hematology · 29d
Cleared Dec 12, 2022
Medidenta High Speed Handpieces
K202674 · EFB
Pac-Dent, Inc.
Dental · 818d
Cleared Dec 12, 2022
BioButton System
K212957 · DRG
Biolntellisense, Inc.
Cardiovascular · 452d
Cleared Dec 12, 2022
Metal Bone Screw
K220921 · HWC
Double Medical Technology, Inc.
Orthopedic · 257d
Cleared Dec 12, 2022
Spectra Wearable
K220926 · HGX
Uzinmedicare Co., Ltd.
Obstetrics & Gynecology · 256d
Cleared Dec 12, 2022
VITROS Immuodiagnostic Products CA 125 II Reagent Pack
K221355 · LTK
Ortho-Clinical Diagnostics
Immunology · 216d
Cleared Dec 12, 2022
SIRIUS Endoscope System
K221642 · HET
Precision Robotics (Hong Kong) Limited
General & Plastic Surgery · 189d
Cleared Dec 12, 2022
Hive™ Standalone Cervical System
K223190 · OVE
NanoHive Medical, LLC
Orthopedic · 60d
Cleared Dec 12, 2022
Matrix HA Fusion Porous Cervical IBF System
K223510 · ODP
Innovasis, Inc.
Orthopedic · 20d
Cleared Dec 11, 2022
Disposable Nitrile Examination Glove (Tested for use with Chemotherapy Drug)
K222733 · LZA
Inner Mongolia Boming Medical...
General Hospital · 93d
Cleared Dec 09, 2022
Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe
K213054 · FMF
Medline Industries, Inc.
General Hospital · 443d
Cleared Dec 09, 2022
RobPath® Total Hip Application
K220774 · OLO
Hangzhou Lancet Robotics Co., Ltd.
Orthopedic · 268d
Cleared Dec 09, 2022
3D-SHAPER
K220822 · KGI
3D-Shaper Medical S.L
Radiology · 263d
Cleared Dec 09, 2022
PMT Facet Fixation System (PMT FFS)
K220951 · MRW
Providence Medical Technology, Inc.
Orthopedic · 252d
Cleared Dec 09, 2022
Vesseal
K221280 · GAW
Lydus Medical , Ltd.
General & Plastic Surgery · 220d
Cleared Dec 09, 2022
Wearable breast pump
K221598 · HGX
Mayborn (Uk) Limited
Obstetrics & Gynecology · 190d
Cleared Dec 09, 2022
Inogen Rove 4 Portable Oxygen Concentrator
K222086 · CAW
Inogen
Anesthesiology · 147d
Cleared Dec 09, 2022
Swang-Ganz IQ pulmonary artery catheter
K222117 · DYG
Edwards Lifesiences, LLC
Cardiovascular · 144d
Cleared Dec 09, 2022
FloPatch FP120
K222242 · DPW
Flosonics Medical
Cardiovascular · 136d
Cleared Dec 09, 2022
120V Neptune S Rover (0711-001-000)
K222552 · JCX
Stryker Instruments
General & Plastic Surgery · 108d
Cleared Dec 09, 2022
Stryker Cutomized Mandible Recon Plate
K222650 · JEY
Stryker Craniomaxillofacial (Cmf)
Dental · 99d
Cleared Dec 09, 2022
SeaSpine 7D Navigation Instruments
K222753 · OLO
SeaSpine Orthopedics Corporation
Orthopedic · 88d