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

Filters: Cleared only ×
175,820 results
34009–34032 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 18, 2015
CoStorSol plus G
K151728 · KDN
Preservation Solutions, Inc.
Gastroenterology & Urology · 84d
Cleared Sep 18, 2015
STARband, STARlight
K151979 · OAN
Orthomerica Products, Inc.
Neurology · 63d
Cleared Sep 18, 2015
Thoratec CentriMag Return (Arterial) Cannula Kit
K152161 · DWF
Thoratec Corporation
Cardiovascular · 46d
Cleared Sep 18, 2015
Thoratec CentriMag Drainage (Venous) Cannula Kit
K152190 · DWF
Thoratec Corporation
Cardiovascular · 44d
Cleared Sep 18, 2015
iLab Ultrasound Imaging System
K152316 · IYO
Boston Scientific
Radiology · 32d
Cleared Sep 18, 2015
Export Advance Aspiration Catheter
K152335 · DXE
Medtronic, Inc.
Cardiovascular · 30d
Cleared Sep 18, 2015
Eclipse Treatment Planning System
K152393 · MUJ
Varian Medical Systems, Inc.
Radiology · 25d
Cleared Sep 17, 2015
KSEA CMOS Camera System (C-cam)
K143640 · GCJ
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 269d
Cleared Sep 17, 2015
LDR Spine ROI-C Cervical Cage System
K150765 · OVE
Ldr Spine USA
Orthopedic · 177d
Cleared Sep 17, 2015
LifePearl Microshperes
K150958 · KRD
MicroVention, Inc.
Cardiovascular · 161d
Cleared Sep 17, 2015
LeForte System II
K150965 · JEY
Jeil Medical Corporation
Dental · 160d
Cleared Sep 17, 2015
SmartLinx Vitals Plus Patient Monitoring System
K151071 · MWI
Capsule Technologie Sas
Cardiovascular · 149d
Cleared Sep 17, 2015
BodyGuardian Remote Monitoring System
K151188 · DSI
Preventice
Cardiovascular · 136d
Cleared Sep 17, 2015
Radifocus Glidewire Endoscopic Wire
K151471 · OCY
Terumo Medical Corporation
Gastroenterology & Urology · 108d
Cleared Sep 17, 2015
DEFENDO Bronchoscopy Suction Valve
K151522 · KTI
Medivators, Inc.
Ear, Nose, Throat · 104d
Cleared Sep 17, 2015
Everest Spinal System
K151727 · NKB
K2m, Inc.
Orthopedic · 83d
Cleared Sep 17, 2015
New Deantronics Smoke Evacuation Adapter with 10mm connector. New Deantronics...
K152031 · GEI
New Deantronics Taiwan , Ltd.
General & Plastic Surgery · 57d
Cleared Sep 17, 2015
ODALYS Pedicle Screw System
K152098 · MNI
Kisco International
Orthopedic · 51d
Cleared Sep 17, 2015
Reliance Spinal Screw System
K152131 · MNI
Reliance Medical Systems, LLC
Orthopedic · 48d
Cleared Sep 17, 2015
FreeStyle InsuLinx Blood Glucose Monotioring System
K152328 · LFR
Abott Laboratories
Chemistry · 30d
Cleared Sep 16, 2015
Partial Knee Application (PKA)
K142530 · OLO
Mako Surgical Corporation
Orthopedic · 372d
Cleared Sep 16, 2015
ArgenIS Titanium Abutments
K143051 · NHA
The Argen Corporation
Dental · 328d
Cleared Sep 16, 2015
Gynomunal
K143349 · NUC
Polichem S.A
Obstetrics & Gynecology · 296d
Cleared Sep 16, 2015
Ackermann Intervertebral Body Fusion Device
K143450 · ODP
Ackermann Instrumente GmbH
Orthopedic · 288d