Search FDA 510(k) Database

7,165 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
23041–23064 of 174,061
Cleared Oct 05, 2018
SHINY RPL System
K181868 · ONF
Ids, Ltd.
General & Plastic Surgery · 85d
Cleared Oct 05, 2018
Sense System with IBT Electrodes
K182112 · GXY
Infinite Biomedical Technologies, LLC
Neurology · 60d
Cleared Oct 04, 2018
CURA 16
K173076 · JAK
Fmi Medical Systems, Inc.
Radiology · 370d
Cleared Oct 04, 2018
Diazyme 1,5-AG Assay
K180209 · NOZ
Diazyme Laboratories, Inc.
Chemistry · 253d
Cleared Oct 04, 2018
WishBone Medical Plate and Screw System
K180736 · HRS
Wishbone Medical, Inc.
Orthopedic · 196d
Cleared Oct 04, 2018
Rhino-Laryngo Fiberscope Olympus ENF-GP2
K181240 · EOB
Olympus Medical Systems Corp.
Ear, Nose, Throat · 147d
Cleared Oct 04, 2018
SYMPHONY™ OCT System
K181949 · NKG
Medos International SARL
Orthopedic · 76d
Cleared Oct 04, 2018
Prase MIS Spinal System
K182059 · NKB
Gbs Commonwealth Co., Ltd.
Orthopedic · 65d
Cleared Oct 04, 2018
Ureteric Catheters
K182122 · EYB
Coloplast Corp.
Gastroenterology & Urology · 59d
Cleared Oct 04, 2018
Encompass SRS Headframe
K182189 · IYE
Qfix
Radiology · 52d
Cleared Oct 04, 2018
HYBRID Guidewire
K182337 · MOF
Balt USA, LLC
Neurology · 37d
Cleared Oct 04, 2018
MAGLUMI 2000 FT4
K182423 · CEC
Shenzhen New Industries Biomedical...
Chemistry · 28d
Cleared Oct 04, 2018
POWEREASE System
K182436 · HBE
Medtronic Sofamor Danek USA, Inc.
Neurology · 27d
Cleared Oct 04, 2018
PIXX 1717
K182533 · MQB
Pixxgen Corporation
Radiology · 20d
Cleared Oct 03, 2018
ARIX Clavicle System
K180972 · HRS
Jeil Medical Corporation
Orthopedic · 173d
Cleared Oct 03, 2018
IS-III active System
K181138 · DZE
Neobiotech Co., Ltd.
Dental · 156d
Cleared Oct 03, 2018
Caretaker Remote Display App and Caretaker Software Library
K181196 · DRG
Caretaker Medical, LLC
Cardiovascular · 149d
Cleared Oct 03, 2018
uMR 780
K181370 · LNH
Shanghai United Imaging Healthcare...
Radiology · 133d
Cleared Oct 03, 2018
uMR 790
K181371 · LNH
Shanghai United Imaging Healthcare...
Radiology · 133d
Cleared Oct 03, 2018
On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose...
K181527 · NBW
ACON Laboratories, Inc.
Chemistry · 114d
Cleared Oct 03, 2018
Outlet Sacroiliac Joint Fusion System
K181881 · OUR
Sij Surgical
Orthopedic · 82d
Cleared Oct 03, 2018
FIREFLY® Midline Navigation Guide
K181883 · PQC
Mighty Oak Medical, Inc.
Orthopedic · 82d
Cleared Oct 03, 2018
BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes,...
K181903 · JAQ
Varian Medical Systems, Inc.
Radiology · 79d
Cleared Oct 03, 2018
Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation...
K182050 · IYE
Siemens Medical Solutions USA, Inc.
Radiology · 64d