Search FDA 510(k) Database

7,099 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
20617–20640 of 174,061
Cleared Aug 06, 2019
Percutaneous Introducer Needle
K191295 · GCJ
Progressive Medical, Inc.
General & Plastic Surgery · 84d
Cleared Aug 06, 2019
Normandy VBR System
K191423 · PLR
Zavation Medical Products, LLC
Orthopedic · 69d
Cleared Aug 06, 2019
Endoskeleton TCS Interbody Fusion Device
K191565 · OVE
Titan Spine, Inc.
Orthopedic · 54d
Cleared Aug 06, 2019
Wagner SL Revision Stem Lateral and Wagner Cone Prosthesis System
K191781 · LZO
Zimmer GmbH
Orthopedic · 35d
Cleared Aug 06, 2019
CREO Stabilization System, Navigation Instruments, ExcelsiusGPS Instruments
K191835 · NKB
Globus Medical, Inc.
Orthopedic · 28d
Cleared Aug 05, 2019
Crossing Support Catheter
K183305 · DQY
Tractus Vascular, LLC
Cardiovascular · 250d
Cleared Aug 05, 2019
UPJ Occlusion Balloon Catheter
K183323 · EYB
Cook Incorporated
Gastroenterology & Urology · 248d
Cleared Aug 05, 2019
Beddr 200 System
K190399 · DQA
Hancock Medical, Inc.
Anesthesiology · 167d
Cleared Aug 05, 2019
LunaGuard Nighttime Dental Protector
K191033 · OBR
Mckeon Products
Dental · 109d
Cleared Aug 05, 2019
Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech...
K191222 · NHA
Prismatik Dentalcraft, Inc.
Dental · 90d
Cleared Aug 05, 2019
EEG Electrode Template
K191225 · GXY
Rhythmlink International, LLC
Neurology · 90d
Cleared Aug 05, 2019
aBSI
K191262 · LLZ
Exini Diagnostics AB
Radiology · 87d
Cleared Aug 05, 2019
TDS Standard Solution
K191496 · FKH
Mesa Laboratories, Inc.
Gastroenterology & Urology · 61d
Cleared Aug 05, 2019
VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4µg/mL)
K191766 · LON
bioMerieux, Inc.
Microbiology · 35d
Cleared Aug 05, 2019
FLUOROspeed
K191877 · JAA
Shimadzu Corporation
Radiology · 21d
Cleared Aug 02, 2019
Med-link Wrist Digital Blood Pressure Monitor, Med-link Upper Arm Digital...
K181154 · DXN
Shenzhen Med-Link Electronics Tech...
Cardiovascular · 458d
Cleared Aug 02, 2019
HAMILTON-T1, HAMILTON-C1
K181216 · CBK
Hamilton Medical AG
Anesthesiology · 452d
Cleared Aug 02, 2019
ADVIA Centaur Erythropoietin (EPO) assay
K183088 · GGT
Axis-Shield Diagnostics Limited
Hematology · 269d
Cleared Aug 02, 2019
Elaris Pedicle Screw System
K183091 · NKB
Spinewelding AG
Orthopedic · 269d
Cleared Aug 02, 2019
DiLumen Endolumenal Interventional Knife (“DiLumen IK™”)
K183112 · GEI
Lumendi, LLC
Gastroenterology & Urology · 267d
Cleared Aug 02, 2019
DynoSense Vital Sign Measuring System
K190090 · MWI
Dynosense Corp.
Cardiovascular · 197d
Cleared Aug 02, 2019
Single Use Cytology Brush BC-205D
K190293 · BTG
Olympus Medical Systems Corp.
Anesthesiology · 172d
Cleared Aug 02, 2019
046 Zenith Flex
K190338 · NRY
Inneuroco, Inc.
Neurology · 169d
Cleared Aug 02, 2019
PowerFlow Implantable Apheresis IV Port
K191143 · PTD
C.R. Bard, Inc.
General Hospital · 94d