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
31033–31056 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 26, 2016
Xenocor Xenoscope Laparoscopic System
K161838 · GCJ
Xenocor, Inc.
General & Plastic Surgery · 83d
Cleared Sep 26, 2016
PORTAGE System
K161878 · HRX
Baylis Medical Company, Inc.
Orthopedic · 80d
Cleared Sep 23, 2016
VSP Cranial System
K151285 · PPT
3D Systems, Inc.
Neurology · 498d
Cleared Sep 23, 2016
PASS XS Spinal System
K160640 · NKB
Medicrea International SA
Orthopedic · 200d
Cleared Sep 23, 2016
BD Vacutainer Barricor Lithium Heparin Plasma Blood Collection Tube
K160657 · JKA
Becton, Dickinson and Company
Chemistry · 199d
Cleared CT Sep 23, 2016
Photonica Professional
K160880 · OLI
Ward Photonics, LLC
General & Plastic Surgery · 177d
Cleared Sep 23, 2016
O2VENT T
K161832 · LRK
Oventus Manufacturing Pty, Ltd.
Dental · 80d
Cleared Sep 23, 2016
EXPRT Revision Knee Femoral Augment(5mm), EXPRT Revision Knee Stem Extension...
K161945 · JWH
Encore Medical, L.P.
Orthopedic · 70d
Cleared Sep 23, 2016
FixxSure® X-Link
K162143 · MNH
Innovasis, Inc.
Orthopedic · 53d
Cleared Sep 22, 2016
DONASORB SILVER WOUND DRESSING
K153565 · FRO
Virchow Biotech Pvt, Ltd.
General & Plastic Surgery · 283d
Cleared Sep 22, 2016
Emergency Transtracheal Airway Catheter
K153761 · BWC
Cook Incorporated
Anesthesiology · 267d
Cleared Sep 22, 2016
Pure Vu
K160015 · FDF
Motus GI Medical Technologies , Ltd.
Gastroenterology & Urology · 262d
Cleared Sep 22, 2016
MiniMed Quick-serter
K160860 · KZH
Medtronic Minimed
General Hospital · 177d
Cleared CT Sep 22, 2016
Ahead 300
K161068 · PIW
Brainscope Company, Inc.
Neurology · 160d
Cleared Sep 22, 2016
DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging...
K161368 · MQB
Agfa Healthcare N.V.
Radiology · 128d
Cleared Sep 22, 2016
BIB Stent Placement Catheter
K161451 · NVM
NuMED, Inc.
Cardiovascular · 119d
Cleared Sep 22, 2016
Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt...
K161992 · JXG
Integra LifeSciences Corporation
Neurology · 65d
Cleared Sep 22, 2016
Aerin Medical Stylus
K161994 · GEI
Aerin Medical, Inc.
General & Plastic Surgery · 65d
Cleared Sep 22, 2016
Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with...
K162188 · PNR
Vr Medical Technology
Gastroenterology & Urology · 49d
Cleared Sep 22, 2016
ArtPix Mobile EZ2GO
K162224 · KPR
Cmt Medical Technologies, Ltd.
Radiology · 45d
Cleared Sep 22, 2016
PowerGlide Pro Midline Catheter
K162377 · FOZ
C.R. Bard, Inc.
General Hospital · 29d
Cleared Sep 22, 2016
TrailBlazer Angled Support Catheter
K162384 · DQY
Medtronic Vascular, Inc.(Formerly Ev3...
Cardiovascular · 28d
Cleared Sep 21, 2016
CPL Insulin Pen Needle
K151090 · FMI
Cpl Co., Ltd.
General Hospital · 517d
Cleared Sep 21, 2016
ATLANTIS ISUS Implant Suprastructures
K160207 · NHA
Dentsply International, Inc.
Dental · 237d