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
35185–35208 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 30, 2015
iTClamp50
K150813 · DXC
Innovative Trauma Care, Inc.
Cardiovascular · 34d
Cleared Apr 30, 2015
INCITE ANCHORED CERVICAL INTERBODY DEVICE
K150913 · OVE
Incite Innovation
Orthopedic · 24d
Cleared Apr 30, 2015
Vitaphone Tele ECG Loop Recorder
K151013 · DXH
Vitasystems GmbH
Cardiovascular · 15d
Cleared Apr 29, 2015
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K141984 · DXN
Andon Health Co, Ltd.
Cardiovascular · 282d
Cleared Apr 29, 2015
ST'RIM
K142073 · MUU
Thiebaud Sas
General & Plastic Surgery · 272d
Cleared Apr 29, 2015
HUDSON RCI ADDIPAK UNIT DOSE VIAL, 0.9% FULL NORMAL SALINE SOLUTION, 3ML
K142153 · CAF
Teleflexmedical, Inc.
Anesthesiology · 266d
Cleared Apr 29, 2015
Zavation Posterior LEIF
K142392 · MAX
Zavation, LLC
Orthopedic · 245d
Cleared Apr 29, 2015
GenCut Core Biopsy System
K142839 · EOQ
Covidien, LLC
Ear, Nose, Throat · 211d
Cleared Apr 29, 2015
Reliance Posterior Cervical-Thoracic System
K142867 · KWP
Reliance Medical Systems, LLC
Orthopedic · 210d
Cleared Apr 29, 2015
RENASYS
K142979 · OMP
Smith & Nephew, Inc.
General & Plastic Surgery · 196d
Cleared Apr 29, 2015
iCase Contact Lens Case
K143351 · LRX
Novabay Pharmaceuticals, Inc.
Ophthalmic · 156d
Cleared Apr 29, 2015
NuVasive(R) CCX-L Interbody System
K143595 · MAX
Nu Vasive, Incorporated
Orthopedic · 132d
Cleared Apr 29, 2015
SMV Scientific 4.5 mm Bone Screws
K150188 · HWC
Summit Medventures
Orthopedic · 92d
Cleared Apr 29, 2015
PHALINX Hammertoe System
K150252 · HWC
Wrightmedicaltechnologyinc
Orthopedic · 85d
Cleared Apr 29, 2015
Republic Spine Dark Star Spinal System
K150283 · MNH
Republic Spine, LLC
Orthopedic · 83d
Cleared Apr 29, 2015
Arthrex Plates, Screws, and Staples
K150456 · HRS
Arthrex, Inc.
Orthopedic · 68d
Cleared Apr 29, 2015
DARCO Locking Bone Plate System
K150520 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 58d
Cleared Apr 29, 2015
Cardinal Health External Fixation System
K150579 · KTT
Cardinalhealth
Orthopedic · 51d
Cleared Apr 29, 2015
ULTRA Telescopes
K150633 · GCJ
Olympus Winter & Ibe GmbH
General & Plastic Surgery · 49d
Cleared Apr 29, 2015
OUTBACK Elite Re-Entry Catheter
K150836 · PDU
Cordis Corporation, A Johnson &...
Cardiovascular · 30d
Cleared Apr 29, 2015
IS4000 Small Clip Applier, IS4000 Long Bipolar Forceps
K150837 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 30d
Cleared Apr 29, 2015
aap Cortical Screw 1.5, self-tapping, aap Cortical Screw 1.5, self-tapping,...
K150974 · HWC
Aap Implantate AG
Orthopedic · 16d
Cleared Apr 28, 2015
Visage Ease Pro
K142196 · LLZ
Visage Imaging GmbH
Radiology · 260d
Cleared Apr 28, 2015
CAS-One Liver
K143024 · OEW
Cascination AG
General & Plastic Surgery · 189d