Search FDA 510(k) Database

6,833 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
14905–14928 of 174,061
Cleared Jul 28, 2021
Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook...
K211875 · DTK
William Cook Europe Aps
Cardiovascular · 41d
Cleared Jul 28, 2021
Catalyst R1 Reverse Shoulder System
K211991 · PHX
Catalyst Orthoscience, Inc.
Orthopedic · 30d
Cleared Jul 28, 2021
Braun Silk.expert Mini
K211994 · OHT
Cyden Limited
General & Plastic Surgery · 30d
Cleared Jul 27, 2021
Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair,...
K201326 · DJG
Psychemedics Corporation
Toxicology · 434d
Cleared Jul 27, 2021
Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot...
K210016 · HRS
Integra LifeSciences Corporation
Orthopedic · 204d
Cleared Jul 27, 2021
Insight Agile DRF
K210469 · JAA
Imaging Engineering, LLC
Radiology · 161d
Cleared Jul 27, 2021
Route 92 Medical Full Length 088 Access System
K210635 · QJP
Route 92 Medical, Inc.
Neurology · 146d
Cleared Jul 27, 2021
DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101)
K210664 · PDU
Ra Medical Systems,Inc
Cardiovascular · 144d
Cleared Jul 27, 2021
doctorgram Stethoscope DES-I
K210736 · DQD
Gv Concepts
Cardiovascular · 138d
Cleared Jul 27, 2021
Us2.v1
K210791 · QIH
Eko.Ai Pte Ltd. D/B/A Us2.Ai
Radiology · 133d
Cleared Jul 27, 2021
1Derful HS, 1Derful HT
K210884 · EIH
1derful, Inc.
Dental · 124d
Cleared Jul 27, 2021
PET VCAR
K211247 · KPS
GE Medical Systems SCS
Radiology · 92d
Cleared Jul 27, 2021
Volpara Imaging Software
K211279 · LLZ
Volpara Health Technologies Limited
Radiology · 91d
Cleared Jul 27, 2021
Senhance Surgical System
K211325 · NAY
Asensus Surgical, Inc.
General & Plastic Surgery · 88d
Cleared Jul 27, 2021
aPROMISE
K211655 · LLZ
Exini Diagnostics AB
Radiology · 60d
Cleared Jul 27, 2021
Fixxsure Anterior Lumbar Plate and Screw System
K211932 · KWQ
Oak Tree Engineering, LLC
Orthopedic · 35d
Cleared Jul 27, 2021
Aveir Introducer
K211989 · DYB
Abbott Medical
Cardiovascular · 29d
Cleared Jul 27, 2021
Rist 071 Radial Access Guide Catheter
K211990 · DQY
Micro Therapeutics, Inc. d/b/a ev3...
Neurology · 29d
Cleared Jul 27, 2021
ClariCT.AI
K212074 · LLZ
Claripi, Inc.
Radiology · 25d
Cleared Jul 26, 2021
OncoMate MSI Dx Analysis System
K200129 · PZJ
Promega Corporation
Pathology · 552d
Cleared Jul 26, 2021
Pac-Dent Ceramic Nanohybrid Resin
K210412 · EBF
Pac-Dent, Inc.
Dental · 165d
Cleared Jul 26, 2021
AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE
K210477 · OCL
AtriCure, Inc.
Cardiovascular · 157d
Cleared Jul 26, 2021
Vision Monitor - MonpackONE
K211643 · GWE
Metrovision
Ophthalmic · 60d
Cleared Jul 25, 2021
MASC Surgical Mask
K211984 · FXX
Mid-America Safety Corp.
General Hospital · 30d