Search FDA 510(k) Database

6,969 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
18265–18288 of 174,061
Cleared May 21, 2020
Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with...
K201068 · KFM
Medtronic, Inc.
Cardiovascular · 29d
Cleared May 21, 2020
Advincula Delineator Uterine Manipulator
K201086 · HEW
CooperSurgical, Inc.
Obstetrics & Gynecology · 28d
Cleared May 21, 2020
IntraMarX 3D Radiopaque Marker
K201106 · FFX
Anx Robotica Corp
Gastroenterology & Urology · 27d
Cleared May 20, 2020
LifeFlow Blood System
K191362 · FPA
410 Medical, Inc.
General Hospital · 364d
Cleared May 20, 2020
Infinity Angioplasty Balloon Catheter
K192399 · LIT
Infinity Angioplasty Balloon Company,...
Cardiovascular · 260d
Cleared May 20, 2020
K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)
K192727 · DHR
Kamiya Biomedical Company
Immunology · 236d
Cleared May 20, 2020
Axis Spine Technologies ALIF
K200352 · OVD
Axis Spine Technologies, Ltd.
Orthopedic · 97d
Cleared May 20, 2020
HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN)
K200860 · ESW
M.I. Tech Co., Ltd.
Gastroenterology & Urology · 49d
Cleared May 20, 2020
NuVasive® ACP System
K201078 · KWQ
Nu Vasive, Incorporated
Orthopedic · 28d
Cleared May 19, 2020
SMOOV O10
K192016 · ITI
Alber GmbH
Physical Medicine · 295d
Cleared May 19, 2020
Reform Pedicle Screw System
K200303 · NKB
Precision Spine
Orthopedic · 103d
Cleared May 19, 2020
CUBEScan BioCon-900S
K200749 · IYO
Mcube Technology Co., Ltd.
Radiology · 57d
Cleared May 19, 2020
5MP Color LCD Monitors C53S+, C53SP+, 5MP Monochrome LCD Monitors G53S+, G53SP+
K200864 · PGY
Shenzhen Beacon Display Technology...
Radiology · 48d
Cleared May 19, 2020
TOPAZ Mobile DR System
K201124 · IZL
DRGEM Corporation
Radiology · 22d
Cleared May 18, 2020
MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto...
K191906 · MAX
MiRus, LLC
Orthopedic · 307d
Cleared May 18, 2020
UF(II) Bar holder abutment
K193404 · NHA
Dio Corporation
Dental · 164d
Cleared May 18, 2020
VarseoSmile Temp
K193553 · EBG
Bego Bremer Goldschlagerei Wilh....
Dental · 150d
Cleared May 18, 2020
Catalys Precision Laser System
K200056 · OOE
Amo Manufacturng USA, LLC
Ophthalmic · 126d
Cleared May 18, 2020
V.A.C. DERMATAC Drape
K200390 · OMP
Kci USA, Inc.
General & Plastic Surgery · 90d
Cleared May 18, 2020
3D GraftRasp System
K200431 · FMF
Surgentec
General & Plastic Surgery · 87d
Cleared May 18, 2020
Natus NeuroWorks
K200878 · OMB
Natus Medical Incorporated Dba...
Neurology · 46d
Cleared May 18, 2020
syngo Ultrasound Apps Suite (sUSAS)
K201062 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 27d
Cleared May 17, 2020
Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System)
K200866 · QEP
Hologic, Inc.
Microbiology · 46d
Cleared May 15, 2020
Medtronic Commander Flex
K191745 · DXN
Medtronic Care Management Services
Cardiovascular · 319d