Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

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

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175,820 results
30769–30792 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 28, 2016
Klassic Knee System
K162422 · JWH
Total Joint Orthopedics, Inc.
Orthopedic · 59d
Cleared Oct 28, 2016
Codman EDS3 CSF External Drainage System
K162437 · JXG
Codman & Shurtleff, Inc.
Neurology · 58d
Cleared Oct 28, 2016
Arterys Software v2.0
K162513 · LLZ
Arterys, Inc.
Radiology · 50d
Cleared Oct 28, 2016
SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI NanoMetalene,...
K162715 · MAX
SeaSpine Orthopedics Corporation
Orthopedic · 29d
Cleared Oct 27, 2016
ETIII SA Fixture System (O3.2mm)
K153332 · DZE
Hiossen, Inc.
Dental · 343d
Cleared Oct 27, 2016
CorPath GRX System
K160121 · DXX
Corindus, Inc.
Cardiovascular · 282d
Cleared Oct 27, 2016
SPROTTE NRFit, Quincke NRFit
K160295 · BSP
PAJUNK GmbH Medizintechnologie
Anesthesiology · 267d
Cleared Oct 27, 2016
SPROTTE SPECIAL NRFit
K160296 · BSP
PAJUNK GmbH Medizintechnologie
Anesthesiology · 267d
Cleared Oct 27, 2016
SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy...
K160316 · KNW
M.D.L. S.R.L.
Gastroenterology & Urology · 265d
Cleared Oct 27, 2016
HemosIL D-Dimer HS
K160885 · DAP
Instrumentation Laboratory CO
Hematology · 210d
Cleared Oct 27, 2016
ColpoWave™ Colpotomizer and CerviGrip™ Uterine Manipulator
K161065 · HEW
Surgitools Pty , Ltd.
Obstetrics & Gynecology · 195d
Cleared Oct 27, 2016
Smart External Drain (SED) System
K161605 · JXG
Aqueduct Critical Care, Inc.
Neurology · 139d
Cleared Oct 27, 2016
MaxBlend 2, MaxBlend Lite
K161718 · BZR
Maxtec, LLC
Anesthesiology · 127d
Cleared Oct 27, 2016
Torcon NB Advantage Catheters
K161822 · DQO
Cook Incorporated
Cardiovascular · 118d
Cleared Oct 27, 2016
EdgeOne CO2 Laser
K162169 · GEX
Jeisys Medical, Inc.
General & Plastic Surgery · 85d
Cleared Oct 27, 2016
Klassic Femur, Porous, Klassic Tibial Baseplate, Porous
K162256 · MBH
Total Joint Orthopedics, Inc.
Orthopedic · 77d
Cleared Oct 27, 2016
Erisma® LP MIS
K162367 · NKB
Clariance, Sas
Orthopedic · 65d
Cleared Oct 27, 2016
Libra Pedicle Screw System
K162750 · NKB
Spinal Balance, Inc.
Orthopedic · 27d
Cleared Oct 26, 2016
REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip
K160583 · OBJ
Volcano Corporation
Cardiovascular · 239d
Cleared Oct 26, 2016
PLEX Elite 9000 SS-OCT
K161194 · OBO
Carl Zeiss Meditec, Inc.
Ophthalmic · 182d
Cleared Oct 26, 2016
NanoBone SBX Putty
K161351 · MQV
Artoss GmbH
Orthopedic · 163d
Cleared Oct 26, 2016
Reprocessed Orbiter ST Steerable Diagnostic EP Catheter
K161393 · NLH
Innovative Health, LLC
Cardiovascular · 160d
Cleared Oct 26, 2016
Zimmer M/L Taper Hip Prosthesis
K161830 · LZO
Zimmer, Inc.
Orthopedic · 113d
Cleared Oct 26, 2016
NuVasive CoRoent Small Ti-C System
K162138 · ODP
Nu Vasive, Incorporated
Orthopedic · 86d