FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
20641–20664 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 09, 2020
Senhance Surgical System
K200049 · NAY
Transenterix, Inc.
General & Plastic Surgery · 60d
Cleared Mar 09, 2020
Edwards eSheath Introducer Set
K200258 · DYB
Edwards Lifesciences
Cardiovascular · 35d
Cleared Mar 06, 2020
OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation Implant
K190652 · HTY
OSSIO , Ltd.
Orthopedic · 359d
Cleared Mar 06, 2020
SwabTip Male Disinfectant Cap
K190918 · QBP
Icu Medical
General Hospital · 332d
Cleared CT Mar 06, 2020
NightOwl
K191031 · MNR
Ectosense NV
Anesthesiology · 323d
Cleared Mar 06, 2020
Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid...
K191562 · DBF
HORIBA ABX SAS
Immunology · 267d
Cleared Mar 06, 2020
Avinent Surgical Tray
K191566 · KCT
Avinent Implant System S.L.U.
General Hospital · 267d
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