Search FDA 510(k) Database

6,903 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
16921–16944 of 174,061
Cleared Nov 12, 2020
AGILON® XO Shoulder Replacement System
K191433 · HSD
Implantcast GmbH
Orthopedic · 533d
Cleared Nov 12, 2020
EOGas 4 Ethylene Oxide Gas Sterilizer
K192978 · FLF
Andersen Sterilizers, Inc.
General Hospital · 385d
Cleared Nov 12, 2020
EOGas 4 Endo-SteriTest
K192980 · FRC
Andersen Sterilizers, Inc.
General Hospital · 385d
Cleared Nov 12, 2020
FastStroke, CT Perfusion 4D
K193289 · JAK
GE Medical Systems SCS
Radiology · 351d
Cleared Nov 12, 2020
TP Orthodontics Clear Aligner System
K193385 · NXC
Tp Orthodontics, Inc.
Dental · 342d
Cleared Nov 12, 2020
O2asis Personal Oxygen Humidifier
K193411 · BTT
Perma Pure, LLC
Anesthesiology · 339d
Cleared Nov 12, 2020
AN1036 Dosimeter
K200334 · JOJ
Andersen Sterilizers, Inc.
General Hospital · 275d
Cleared Nov 12, 2020
Sterisheet Sterilization Wrap
K200335 · FRG
Andersen Sterilizers, Inc.
General Hospital · 275d
Cleared Nov 12, 2020
Tyvek Sterilization Pouches with Chevron Seal
K200336 · FRG
Andersen Sterilizers, Inc.
General Hospital · 275d
Cleared Nov 12, 2020
Sharps container
K201523 · MMK
Zhejiang Gongdong Medical Technology...
General Hospital · 157d
Cleared Nov 12, 2020
Calvary Spine Pedicle Screw System
K201568 · NKB
Calvary Spine, LLC
Orthopedic · 154d
Cleared Nov 12, 2020
KardiaAI
K201985 · DQK
AliveCor, Inc.
Cardiovascular · 118d
Cleared Nov 12, 2020
Apache Ultrasound System (Model C62)
K202074 · IYN
Compal Electronics, Inc.
Radiology · 108d
Cleared Nov 12, 2020
da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and...
K202571 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 69d
Cleared Nov 12, 2020
Insight Infrared Video Goggles
K203082 · GWN
Vestibular First
Ear, Nose, Throat · 30d
Cleared Nov 12, 2020
NOVA Patient Warming System
K203085 · DWJ
Encompass Group, LLC
Cardiovascular · 30d
Cleared Nov 12, 2020
ExacTrac Dynamic
K203173 · IYE
Brainlab AG
Radiology · 17d
Cleared Nov 11, 2020
Route 92 Medical 070 Access System
K203043 · QJP
Route 92 Medical, Inc.
Neurology · 36d
Cleared Nov 10, 2020
JTK Dental Implant System
K183044 · DZE
Jiangyin Jintech Biotech Co., Ltd.
Dental · 739d
Cleared Nov 10, 2020
WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw...
K193214 · MBI
Biomet, Inc.
Orthopedic · 355d
Cleared Nov 10, 2020
VagiVital Aktivgel
K200098 · NUC
Peptonic Medical AB
Obstetrics & Gynecology · 299d
Cleared Nov 10, 2020
Multi-Drive Interference Screw System
K200428 · MBI
Nvision Biomedical Technologies, Inc.
Orthopedic · 263d
Cleared Nov 10, 2020
StimSite
K200886 · ETN
Allotrope Medical, Inc.
Obstetrics & Gynecology · 222d
Cleared Nov 10, 2020
SnapshotNIR
K201976 · MUD
Kent Imaging
General & Plastic Surgery · 117d