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
40009–40032 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 16, 2013
OVATION 10/12 HIP STEM
K131022 · LPH
Ortho Development Corp.
Orthopedic · 187d
Cleared Oct 16, 2013
FINGERTIP PULSE OXIMETER
K131047 · DQA
Beijing Choice Electronic Technololgy...
Anesthesiology · 184d
Cleared Oct 16, 2013
AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS,...
K131231 · PHX
Tornier S.A.S.
Orthopedic · 169d
Cleared Oct 16, 2013
IFUSE IMPLANT SYSTEM
K131405 · OUR
SI-BONE, Inc.
Orthopedic · 154d
Cleared Oct 16, 2013
SMOOTH OR THREADED METALLIC BONE FASTENER
K131640 · HTY
Biomedical Ent., Inc.
Orthopedic · 134d
Cleared Oct 16, 2013
VANTAGE TITAN 3T
K132160 · LNH
Toshibamedical Systems Corporation
Radiology · 96d
Cleared Oct 16, 2013
.DECIMAL PROTON APERTURE
K132236 · IXI
.Decimal, Inc.
Radiology · 90d
Cleared Oct 16, 2013
A.I.M. SUTURE ANCHOR
K132461 · MBI
Anchor Innovation Medical, Inc.
Orthopedic · 70d
Cleared Oct 16, 2013
ADVIA CHEMISTRY ALBUMIN BCP REAGENT (ALBP), ADVIA CHEMISTRY ALBUMIN BCP...
K132664 · CJW
Siemens Healthcare Diagnostics, Inc.
Chemistry · 50d
Cleared Oct 15, 2013
NON-CONTACT INFRARED THERMOMETER
K130231 · FLL
Jinxinbao Electronic Co.,Ltd
General Hospital · 259d
Cleared Oct 15, 2013
LUNGPOINT TOOLS (LUNGPOINT SHEATH, LUNGPOINT DILATION BALLOON)
K131234 · EOQ
Broncus Medical, Inc.
Ear, Nose, Throat · 167d
Cleared Oct 15, 2013
ENDOCHOICE HOT BIOPSY FORCEPS
K131991 · KGE
Endochoice, Inc.
Gastroenterology & Urology · 109d
Cleared Oct 15, 2013
MULTICHEM U
K131993 · JJY
Techno-Path Manufacturing , Ltd.
Chemistry · 109d
Cleared Oct 11, 2013
BASIC AND DOMINANT FLEX SUCTION PUMPS
K130123 · BTA
Medela AG
General & Plastic Surgery · 267d
Cleared Oct 11, 2013
AUDICOR CPAM WITH SDB (SINGLE SENSOR)
K130660 · MLO
Inovise Medical, Inc.
Cardiovascular · 213d
Cleared Oct 11, 2013
REVERSE MEDICAL MICROCATHETER
K130858 · DQY
Reverse Medical Corporation
Cardiovascular · 197d
Cleared Oct 11, 2013
ACUSON S2000 AND S3000
K130881 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 196d
Cleared Oct 11, 2013
THERAFLOW SINGLE LUMEN AND THERAFLOW DUAL LUMEN
K131023 · NFB
Medical Products, LLC
Anesthesiology · 182d
Cleared Oct 11, 2013
BALANCED KNEE SYSTEM HIGH FLEX VITAMIN E PS TIBIAL INSERT AND PATELLA
K131337 · JWH
Ortho Development Corp.
Orthopedic · 155d
Cleared Oct 11, 2013
ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM
K131366 · LFR
Roche Diagnostics Operations, Inc.
Chemistry · 151d
Cleared Oct 11, 2013
MODIFIED CONCENTRIC MICROCATHETER
K131437 · DQO
Concentric Medical, Inc.
Cardiovascular · 144d
Cleared Oct 11, 2013
SEATTLE - PAP
K131502 · BZD
Seattle Childrens Hospital
Anesthesiology · 140d
Cleared Oct 11, 2013
KATANA ZIRCONIA
K131534 · EIH
Kuraray Noritake Dental, Inc.
Dental · 135d
Cleared Oct 11, 2013
PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
K131677 · HSB
Ellipse Technologies, Inc.
Orthopedic · 123d