Search FDA 510(k) Database

7,142 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
21649–21672 of 174,061
Cleared Mar 27, 2019
VITROS XT Chemistry Products TRIG-CHOL Slides
K190490 · CHH
Ortho-Clinical Diagnostics, Inc.
Chemistry · 27d
Cleared Mar 26, 2019
MobileECG 2 BT
K181658 · DSI
Memtec Corporation
Cardiovascular · 274d
Cleared Mar 26, 2019
transGlideXT Expandable Introducer
K181817 · DYB
Transaortic Medical, Inc.
Cardiovascular · 260d
Cleared Mar 26, 2019
Electric Handpiece Motor
K181858 · EBW
W&H Dentalwerk Buermoos GmbH
Dental · 257d
Cleared Mar 26, 2019
Velano Vascular Q2 Extension Set
K182897 · FPA
Velano Vascular
General Hospital · 161d
Cleared Mar 26, 2019
Dental Pain Eraser
K182947 · LWM
Synapse Dental, LLC
Dental · 154d
Cleared Mar 26, 2019
SM Electrodes
K183154 · GXY
Hong Qiangxing (Shenzhen) Electronics...
Neurology · 132d
Cleared Mar 26, 2019
Arthrex TensionLoc System
K183628 · HWC
Arthrex, Inc.
Orthopedic · 90d
Cleared Mar 26, 2019
Synapse PACS
K190232 · LLZ
Fujifilm Corporation
Radiology · 48d
Cleared Mar 26, 2019
WaveLight FS200 Patient Interface
K190392 · GEX
Alcon Laboratories, Inc.
Ophthalmic · 35d
Cleared Mar 26, 2019
OTIS Optical Coherence Tomography SYstem
K190404 · NQQ
Perimeter Medical Imaging, Inc.
General & Plastic Surgery · 35d
Cleared Mar 25, 2019
InTouch Thermal Camera
K181716 · LHQ
Intouch Technologies, Inc., D.B.A....
Radiology · 270d
Cleared Mar 25, 2019
MUTARS Proximal Femur Replacement System
K181778 · MEH
Implantcast GmbH
Orthopedic · 265d
Cleared Mar 25, 2019
AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced...
K181905 · PCU
Boston Scientific Corporation
Gastroenterology & Urology · 252d
Cleared Mar 25, 2019
Ballancer Gold, 1212
K190015 · IRP
Mego Afek AC , Ltd.
Physical Medicine · 81d
Cleared Mar 25, 2019
Rezum Delivery Device, Rezum Generator
K190093 · KNS
Nxthera (A Boston Scientific Company)
Gastroenterology & Urology · 66d
Cleared Mar 24, 2019
Arm Blood Pressure Monitor
K183491 · DXN
Xuzhou Yongkang Electronic Science...
Cardiovascular · 97d
Cleared Mar 22, 2019
ELMED Laparoscopic Instruments and Accessories
K181173 · GCJ
Elmed Incorporated
General & Plastic Surgery · 324d
Cleared Mar 22, 2019
ON-Q* Pump with Bolus
K181360 · MEB
Halyard Health
General Hospital · 304d
Cleared Mar 22, 2019
Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing,...
K181624 · CCK
Oridion Medical 1987 , Ltd.
Anesthesiology · 275d
Cleared Mar 22, 2019
Polyethylene Catheter
K181722 · DQO
Cook Incorporated
Cardiovascular · 266d
Cleared Mar 22, 2019
Medline ReNewal Reprocessed OxiMax Pulse Oximetry Sensors
K181738 · DQA
Surgical Instrument Service and...
Anesthesiology · 263d
Cleared Mar 22, 2019
HALYARD SMART-FOLD* Sterilization Wrap (H450, H650)
K181959 · FRG
Owens & Minor Halyard, Inc.
General Hospital · 242d
Cleared Mar 22, 2019
CMOS Video-Rhino-Laryngoscope System
K182186 · EOB
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 221d