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
34993–35016 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 22, 2015
Rachel's Remedy
K150139 · IMA
Rachel'S Remedies, LLC
Physical Medicine · 120d
Cleared May 22, 2015
CalcaNail Orthopedic Nail
K150463 · HSB
Fournitures Hospitalieres Industrie
Orthopedic · 88d
Cleared May 22, 2015
CalcaNail Orthopedic Arthrodesis Nail
K150471 · HSB
Fournitures Hospitalieres Industrie
Orthopedic · 88d
Cleared May 22, 2015
Marrow Cellution Bone Marrow Aspiration Needle
K150563 · KNW
Ranfac, Corp.
Gastroenterology & Urology · 77d
Cleared May 22, 2015
Response 5.5/6.0 Spine System
K150600 · NKB
OrthoPediatrics Corp.
Orthopedic · 73d
Cleared May 22, 2015
VentriPoint Medical System
K150628 · IYN
Ventripoint, Inc.
Radiology · 72d
Cleared May 22, 2015
LipoFilter - Hospital Pack, LipoFilter - Clinic Pack
K150779 · MUU
Microaire Surgical Instruments, LLC
General & Plastic Surgery · 58d
Cleared May 22, 2015
Stryker Maestro Air Motors
K150801 · HBB
Stryker Corporation
Neurology · 57d
Cleared May 22, 2015
Somnowell Mandibular Advancement Appliance (MAA)
K150941 · LRK
Somnowell , Ltd.
Dental · 44d
Cleared May 22, 2015
MicroTaper Needle Introducer Set
K151076 · DRE
Summit Access, LLC
Cardiovascular · 30d
Cleared May 22, 2015
Bausch + Lomb Injector System
K151102 · MSS
Bausch & Lomb, Inc.
Ophthalmic · 28d
Cleared May 22, 2015
Cautery Tip Cleaner
K151222 · GEI
Key Surgical, Inc.
General & Plastic Surgery · 15d
Cleared May 21, 2015
LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges,...
K142895 · LTK
Fujirebio Diagnostics,Inc.
Immunology · 230d
Cleared May 21, 2015
Intelli-Ox
K143060 · ECX
Air Liquide Healthcare
Anesthesiology · 209d
Cleared May 21, 2015
InvisionECG System
K143436 · DPS
Invisionheart, Inc.
Cardiovascular · 171d
Cleared May 21, 2015
Darlinghurst Vented, Darlinghurst NV-AAV
K143603 · BZD
Resmed, Ltd.
Anesthesiology · 154d
Cleared May 21, 2015
Milagro / Milagro Advance Interference Screw
K143660 · MAI
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 149d
Cleared May 21, 2015
SmartGownTM surgical gown
K150151 · FYA
Cardinal Health 200, Inc.
General Hospital · 118d
Cleared May 21, 2015
PlasmaBlade UPPP and Suction Coagulator
K150297 · GEI
Medtronic Advanced Energy
General & Plastic Surgery · 104d
Cleared May 21, 2015
Erchonia Zerona 6 headed scanner EZ6
K150446 · OLI
Erchonia Corporation
General & Plastic Surgery · 90d
Cleared May 21, 2015
Retina Workplace
K150467 · NFJ
Carl Zeiss Meditec, AG
Ophthalmic · 87d
Cleared May 21, 2015
Vital-Port Vascular Access System Power Injectable Port
K150733 · LJT
Cook Incorporated
General Hospital · 62d
Cleared May 20, 2015
TANAKA ZIRCOLOR COLORING LIQUID, TANAKA ZIRCOLOR DIPPING LIQUID AND TANAKA...
K140491 · EIH
Tanaka Dental
Dental · 447d
Cleared May 20, 2015
RAPIDFRET ORAL FLUID ASSAY FOR AMPHETAMINE, RAPIDFRET ORAL FLUID AMPHETAMINE...
K141748 · DKZ
Biophor Diagnostics, Inc.
Toxicology · 324d