Search FDA 510(k) Database

7,148 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
21913–21936 of 174,061
Cleared Feb 22, 2019
Altus Spine Interbody Fusion System
K182406 · MAX
Altus Partners, LLC
Orthopedic · 171d
Cleared Feb 22, 2019
Reprocessed Response Diagnostic Electrophysiology Catheter
K182488 · NLH
Innovative Health, LLC
Cardiovascular · 164d
Cleared Feb 22, 2019
The EPAD 2 System
K182542 · GWF
Safeop Surgical, Inc.
Neurology · 158d
Cleared Feb 22, 2019
IRIS 1.0 System
K182643 · LLZ
Intuitive Surgical
Radiology · 151d
Cleared Feb 22, 2019
FUJIFILM Ultrasonic Endoscope
K182825 · EOQ
Fujifilm Corporation
Ear, Nose, Throat · 141d
Cleared Feb 22, 2019
Babyleo TN500
K182859 · FMZ
Dragerwerk AG & CO Kgaa
General Hospital · 134d
Cleared Feb 22, 2019
Empower RF Catheter
K183240 · GEI
Broncus Medical, Inc.
General & Plastic Surgery · 94d
Cleared Feb 22, 2019
Libertas Acetabular Hooded Liner
K183365 · LZO
Maxx Orthopedics, Inc.
Orthopedic · 80d
Cleared Feb 22, 2019
Choice Spine Hawkeye Vertebral Body Replacement (VBR) System
K183588 · MQP
Choicespine
Orthopedic · 63d
Cleared Feb 22, 2019
EMMA 1.5T MRI System
K183621 · LNH
Time Medical Limited
Radiology · 58d
Cleared Feb 22, 2019
Cellvizio 100 Series Confocal laser Imaging systems and their Confocal...
K183640 · OWN
Mauna Kea Technologies
General & Plastic Surgery · 58d
Cleared Feb 22, 2019
Doctor Tecar
K183693 · PBX
Mectronic Medicale S.R.L.
General & Plastic Surgery · 53d
Cleared Feb 21, 2019
NobelParallel Conical Connection
K173418 · DZE
Nobel Biocare AB
Dental · 477d
Cleared Feb 21, 2019
Devon 62 Deep Vein Thrombosis (DVT) Prevention Therapy Device
K182578 · JOW
Devon Medical Products (Jiangsu), Ltd.
Cardiovascular · 155d
Cleared Feb 21, 2019
Sensus IORT System
K182641 · JAD
Sensus Healthcare, Inc.
Radiology · 150d
Cleared Feb 21, 2019
Sensus TPS Workstation
K182665 · MUJ
Sensus Healthcare, Inc.
Radiology · 149d
Cleared Feb 21, 2019
Coag-Sense Prothrombin Time (PT) / INR Monitoring Device
K183255 · GJS
Coagusense, Inc.
Hematology · 92d
Cleared Feb 21, 2019
HEALIX Ti ANCHOR with DYNACORD
K183279 · MBI
Medos International SARL
Orthopedic · 90d
Cleared Feb 21, 2019
ZOOM Aspiration Pump
K190105 · JCX
Taiwan Biomaterial Co., Ltd.
General & Plastic Surgery · 30d
Cleared Feb 21, 2019
Sensus Healthcare TVM Balloon Applicator
K190255 · JAD
Sensus Healthcare, Inc.
Radiology · 14d
Cleared Feb 20, 2019
AnyCheck IMT-100
K180953 · EKX
Dms Co., Ltd.
Dental · 315d
Cleared Feb 20, 2019
MRIdian Linac System
K181989 · IYE
Viewray, Incorporated
Radiology · 209d
Cleared Feb 20, 2019
VITEK 2 AST-Gram Negative Imipenem (= 16 ug/mL)
K183415 · LON
bioMerieux, Inc.
Microbiology · 72d
Cleared Feb 19, 2019
Byte Aligner System
K180346 · NXC
Straight Smile, LLC
Dental · 376d