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
33769–33792 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 21, 2015
PICC Tip Positioning Aid
K152261 · LJS
Nostix, LLC
General Hospital · 71d
Cleared Oct 21, 2015
CLEARSIGN II Amplifier 40 Channels, CLEARSIGN II Amplifier 80 Channels,...
K152693 · DRQ
Boston Scientific Corporation
Cardiovascular · 30d
Cleared Oct 21, 2015
Diamondback 360 Peripheral Orbital Atherectomy System
K152694 · MCW
Cardiovascular Systems, Inc.
Cardiovascular · 30d
Cleared Oct 21, 2015
iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate...
K152704 · JWH
Conformis, Inc.
Orthopedic · 30d
Cleared Oct 21, 2015
HI-TORQUE BALANCE
K152709 · DQX
Abbott Vascular
Cardiovascular · 30d
Cleared Oct 21, 2015
JOURNEY II XR Knee System
K152726 · JWH
Smith & Nephew, Inc.
Orthopedic · 29d
Cleared Oct 21, 2015
Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound...
K152763 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 27d
Cleared Oct 21, 2015
ProBP 2400 Digital Blood Pressure Device
K152770 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 26d
Cleared Oct 21, 2015
EOS System
K152788 · KPR
Eos Imaging
Radiology · 26d
Cleared Oct 21, 2015
MHI-TM2000 Linear Accelerator System, VERO, Imavis
K152867 · IYE
Mitsubishi Heavy Industries, Ltd.
Radiology · 21d
Cleared Oct 20, 2015
Swiss Navy Premium Silicone Lubricant
K150153 · NUC
Package Solutions, LLC
Obstetrics & Gynecology · 270d
Cleared Oct 20, 2015
Temple Touch Pro (TTP) Non-invasive temperature monitoring system
K150160 · FLL
Medisim, Ltd.
General Hospital · 270d
Cleared Oct 20, 2015
Palm TENS
K150308 · NUH
Heat IN A Click, LLC
Neurology · 253d
Cleared Oct 20, 2015
Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and...
K151389 · DTZ
Terumo Cardiovascular Systems...
Cardiovascular · 147d
Cleared Oct 20, 2015
Ultraviolet Sun Tanning Lamp
K151674 · LEJ
G.I.E.- Gesellschaft Fur...
General & Plastic Surgery · 120d
Cleared Oct 20, 2015
Admira Fusion x-tra
K151956 · EBF
Voco GmbH
Dental · 97d
Cleared Oct 20, 2015
MTS300 Multiple Tray Sterilization System
K152014 · KCT
Pmbs, LLC
General Hospital · 91d
Cleared Oct 20, 2015
Navio
K152574 · OLO
Blue Belt Technologies, Inc.
Orthopedic · 41d
Cleared Oct 19, 2015
AquaC UNO H
K143617 · FIP
Vivonic GmbH
Gastroenterology & Urology · 304d
Cleared Oct 19, 2015
Ranfac Fat Aspiration Transfer Syringe (FATS) Procedure Pack, Ranfac Fat...
K150156 · MUU
Ranfac, Corp.
General & Plastic Surgery · 269d
Cleared Oct 19, 2015
Radifocus Optitorque Angiographic Catheter
K150232 · DQO
Ashitaka Factory of Terumo Corp.
Cardiovascular · 259d
Cleared Oct 19, 2015
QBioScan
K150804 · GZO
Medeia, Inc.
Neurology · 207d
Cleared Oct 19, 2015
AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR Signature...
K151636 · HQC
Abbott Medical Optics, Inc.
Ophthalmic · 124d
Cleared Oct 19, 2015
Opticage Expandable Interbody Fusion Device
K152156 · MAX
Interventional Spine, Inc.
Orthopedic · 77d