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
33625–33648 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 05, 2015
Symphony Breastpump, Symphony reconditioned, Symphony Preemie+ Breastpump,...
K151632 · HGX
Medela AG
Obstetrics & Gynecology · 141d
Cleared Nov 05, 2015
AirView
K151901 · CBK
Resmed, Ltd.
Anesthesiology · 118d
Cleared Nov 05, 2015
FDR D-EVO GL Flat Panel Detector System
K152138 · MQB
Fujifilm Medical System U.S.A., Inc.
Radiology · 97d
Cleared Nov 05, 2015
CD HORIZON Spinal System
K152248 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 87d
Cleared Nov 05, 2015
RECON system- Grubber Lapidus-, Platar Lapidus-, Tarsalis Plates and Screws
K152256 · HRS
Normed Medizin-Technik GmbH
Orthopedic · 87d
Cleared Nov 05, 2015
BD ChloraShield IV Dressing with CHG Antimicrobial
K152923 · FRO
Avery Dennison Belgie Bvba
General & Plastic Surgery · 31d
Cleared Nov 05, 2015
CRIT-LINE CLIP (CLIC) BLOOD CHAMBER
K152953 · KOC
Fresenius Medical Care North America
Gastroenterology & Urology · 29d
Cleared Nov 04, 2015
Safety Auto-Disable Syrine with Needle (Auto-Lock)
K143497 · MEG
Guangdong Intmed Medical Appliance...
General Hospital · 330d
Cleared Nov 04, 2015
Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus...
K150168 · MLM
Siemens Healthcare Diagnostics
Toxicology · 282d
Cleared Nov 04, 2015
Ziostation2
K151212 · LLZ
Qi Imaging, LLC
Radiology · 182d
Cleared Nov 04, 2015
NeuViz 128 Multi-slice CT Scanner System
K151383 · JAK
Neusoft Medical Systems Co., Ltd.
Radiology · 166d
Cleared Nov 04, 2015
KATOR Suture Anchor
K152236 · MBI
Kator, LLC
Orthopedic · 86d
Cleared Nov 03, 2015
SternaLock® 360 Sternal Closure System
K151019 · HRS
Biomet Microfixation
Orthopedic · 201d
Cleared Nov 03, 2015
Talon DistalFix Antegrade/Retrograde Femoral Nail
K152295 · HSB
Orthopedic Designs North America, Inc.
Orthopedic · 82d
Cleared Nov 03, 2015
rescuenet
K152580 · FDI
Endochoice, Inc.
Gastroenterology & Urology · 54d
Cleared Nov 02, 2015
Powder-Free Polyisoprene Sterile Surgical Gloves in White Color Tested for...
K142941 · KGO
Pt. Medisafe Technologies
General Hospital · 389d
Cleared Nov 02, 2015
PGA RESORBA, PGA RESOQUICK, GLYCOLON
K143584 · GAM
Resorba Medical GmbH
General & Plastic Surgery · 319d
Cleared Nov 02, 2015
syngo.CT Myocardial Perfusion
K150713 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 228d
Cleared Nov 02, 2015
Positron Emission Tomography (PET) and Computed Tomography (CT) System,...
K151403 · KPS
Neusoft Medical Systems Co., Ltd.
Radiology · 160d
Cleared Nov 02, 2015
Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Light...
K151470 · HEB
First Quality Hygienic, Inc.
Obstetrics & Gynecology · 154d
Cleared Nov 02, 2015
Avance Y-Connector S
K151872 · OMP
Molnlycke Health Care Us, LLC
General & Plastic Surgery · 116d
Cleared Nov 02, 2015
FastFrame External Fixation System - Knee Spanning, FastFrame External...
K151992 · KTT
Zimmer, Inc.
Orthopedic · 105d
Cleared Nov 02, 2015
EXELINT SecureTouch Safety Hypodermic Needle
K152183 · FMI
Exelint International, Co.
General Hospital · 89d
Cleared Nov 02, 2015
Bovie J-Plasma Precise 360 Handpiece
K152570 · GEI
Bovie Medical Corporation
General & Plastic Surgery · 54d