Search FDA 510(k) Database

7,008 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
18889–18912 of 174,061
Cleared Mar 06, 2020
sam 2.0 Long Duration Ultrasound System
K191568 · PFW
ZetrOZ Systems, LLC
Physical Medicine · 267d
Cleared Mar 06, 2020
PhotonBlade with Smoke Evacuation
K191583 · GEI
Invuity, Inc.
General & Plastic Surgery · 266d
Cleared Mar 06, 2020
MEGAFIX® Pedicle Screw Spinal System
K191655 · NKB
Seohancare Co., Ltd.
Orthopedic · 259d
Cleared Mar 06, 2020
SensiCare Sterile Power-Free Polymer Coated Polyisoprene Sugical Glove,...
K191915 · KGO
Medline Industries, Inc.
General Hospital · 233d
Cleared Mar 06, 2020
Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DR
K192164 · EOQ
Olympus Medical Systems Corp.
Anesthesiology · 210d
Cleared Mar 06, 2020
Plasma IQ
K192813 · GEI
Neauvia North America, Inc.
General & Plastic Surgery · 157d
Cleared Mar 06, 2020
BOND Ready-to-Use Primary Antibody Progesterone Receptor (16), Novocastra...
K193393 · MXZ
Leica Biosystems Newcastle, Ltd.
Pathology · 91d
Cleared Mar 06, 2020
LOSPA® IS™ Spinal Fixation System
K200267 · NKB
Corentec Co., Ltd.
Orthopedic · 32d
Cleared Mar 06, 2020
EPIQ Diagnostic Ultrasound System
K200304 · IYN
Philips Ultrasound, Inc.
Radiology · 29d
Cleared Mar 06, 2020
CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula...
K200306 · DWA
Abbott (Formerly Thoratec Corporation)
Cardiovascular · 29d
Cleared Mar 06, 2020
1688 Pendulum 4K Camera Head with Integrated Coupler, 1688 4K Camera Control...
K200310 · GCJ
Stryker
General & Plastic Surgery · 29d
Cleared Mar 06, 2020
VersaWrap Tendon Protector
K200311 · FTM
Alafair Biosciences, Inc.
General & Plastic Surgery · 29d
Cleared Mar 06, 2020
Insight Enhanced DRF Digital Imaging System
K200396 · JAA
Imaging Engineering, LLC
Radiology · 17d
Cleared Mar 05, 2020
GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis...
K190527 · MSD
C. R. Bard
Gastroenterology & Urology · 367d
Cleared Mar 05, 2020
Kinepict Medical Imaging Tool version v2.2
K190993 · LLZ
Kinepict Health, Ltd.
Radiology · 324d
Cleared Mar 05, 2020
ImmuView S pneumoniae and L pneumophila Urinary Antigen Test
K191184 · MJH
Ssi Diagnostica A/S
Microbiology · 307d
Cleared Mar 05, 2020
V-STRUT Vertebral Implant
K191709 · NDN
Hyprevention Sas
Orthopedic · 253d
Cleared Mar 05, 2020
Ezfil
K191991 · EBF
Meta Biomed Co., Ltd.
Dental · 224d
Cleared Mar 05, 2020
CURA 778
K192590 · JAK
Fmi Medical Systems, Inc.
Radiology · 167d
Cleared Mar 05, 2020
Instinct Plus Endoscopic Clipping Device
K192697 · PKL
Cook Endoscopy
Gastroenterology & Urology · 161d
Cleared Mar 05, 2020
Lucent : IPL
K193072 · ONF
Luvo Medical Technologies, Inc.
General & Plastic Surgery · 122d
Cleared Mar 05, 2020
Omnifix Low Dead Space Luer Lock Syringe
K193101 · FMF
B.Braun Medical, Inc.
General Hospital · 118d
Cleared Mar 05, 2020
ProVecta 3D Prime Ceph
K193139 · OAS
Durr Dental SE
Radiology · 113d
Cleared Mar 05, 2020
Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System
K193147 · PJB
Stereotaxis, Inc.
Cardiovascular · 113d