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
30841–30864 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 20, 2016
COLORADO THERAPEUTICS XENOGRAFT IMPLANT
K160181 · FTM
Colorado Therapeutics, LLC
General & Plastic Surgery · 267d
Cleared Oct 20, 2016
OPTIMUS CMF SYSTEM
K160363 · JEY
Osteonic Co., Ltd.
Dental · 254d
Cleared Oct 20, 2016
Rockwell Medical CitraPure Acid Concetrate
K160847 · KPO
Rockwell Medical
Gastroenterology & Urology · 206d
Cleared Oct 20, 2016
HICP200 Patient/Monitor Interconnect Cable
K161010 · GWM
Innerspace Neuro Solutions, Inc.
Neurology · 192d
Cleared Oct 20, 2016
DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE,...
K161422 · LZA
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 150d
Cleared Oct 20, 2016
Advanced Breast Template System
K161540 · JAQ
Varian Medical Systems, Inc.
Radiology · 139d
Cleared Oct 20, 2016
QuantumCam
K161674 · KPS
Ddd-Diagnostic A/S
Radiology · 126d
Cleared Oct 20, 2016
Q13 SPIROLYSER®
K161676 · BZG
Fim Medical
Anesthesiology · 125d
Cleared Oct 20, 2016
Fluent inflation device
K162272 · MAV
Vascular Solutions, Inc.
Cardiovascular · 69d
Cleared Oct 20, 2016
LiVac Retractor System
K162445 · GCJ
Livac Pty, Ltd.
General & Plastic Surgery · 50d
Cleared Oct 20, 2016
IQM Integral Quality Monitor (also IQM)
K162629 · IYE
Irt Systems
Radiology · 29d
Cleared Oct 20, 2016
Green Smart (Model: PHT-35LHS)
K162660 · OAS
VATECH Co., Ltd.
Radiology · 24d
Cleared Oct 19, 2016
TENS Electrodes
K160081 · GXY
Cathay Manufacturing Corp.
Neurology · 278d
Cleared Oct 19, 2016
Advocate Insulin Pen Needles
K160199 · FMI
Diabetic Supply of Suncoast, Inc.
General Hospital · 265d
Cleared Oct 19, 2016
ADAMANT ZIRCONIA DISC
K160203 · EIH
Adamant Co., Ltd.
Dental · 265d
Cleared Oct 19, 2016
Tyto Stethoscope
K160401 · DQD
Tyto Care , Ltd.
Cardiovascular · 250d
Cleared Oct 19, 2016
ReNew V Handpiece Laparoscopic Instruments
K160706 · GEI
Microline Surgical, Inc.
General & Plastic Surgery · 219d
Cleared Oct 19, 2016
Z-Clamp ISP System
K161016 · PEK
Zavation, LLC
Orthopedic · 191d
Cleared Oct 19, 2016
Klassic HD Hip System
K161073 · LPH
Total Joint Othopedics, Inc.
Orthopedic · 184d
Cleared Oct 19, 2016
Medline Powder-Free Nitrile Exam Glove Extended Cuff (Tested for Use with...
K161473 · LZA
Medline Industries, Inc.
General Hospital · 145d
Cleared Oct 19, 2016
Avance Tubing, Avance Y-Connector, Avance ViewPad
K161797 · OMP
Molnlycke Health Care Us, LLC
General & Plastic Surgery · 111d
Cleared Oct 19, 2016
Pulsaderm Acne Device
K161941 · OLP
Nutra Luxe MD, LLC
General & Plastic Surgery · 96d
Cleared Oct 19, 2016
Ultrasound System SONIMAGE HS1
K162065 · IYN
Konica Minolta, Inc.
Radiology · 85d
Cleared Oct 19, 2016
HDL-Cholesterol Gen.4
K162593 · LBS
Roche Diagnostics Operations (Rdo)
Chemistry · 33d