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
37993–38016 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 06, 2014
BIOMONITOR
K132960 · MXD
Biotronik, Inc.
Cardiovascular · 259d
Cleared Jun 06, 2014
ATOVEN
K133774 · GEX
Bio-Med USA, Inc.
General & Plastic Surgery · 176d
Cleared Jun 06, 2014
CA 125 II CALSET II
K140112 · JIT
Roche Diagnostics
Immunology · 142d
Cleared Jun 06, 2014
STARBAND AND STARLIGHT
K140353 · MVA
Orthomerica Products, Inc.
Neurology · 114d
Cleared Jun 06, 2014
HEALGEN THC ONE STEP MARIJUANA TEST , HEALGEN MAMP ONE STEP METHAMPHETAMINE TEST
K140546 · LDJ
Healgen Scientific, LLC
Chemistry · 94d
Cleared Jun 06, 2014
AXERA 2 ACCESS SYSTEM
K140871 · DYB
Arstasis, Inc.
Cardiovascular · 63d
Cleared Jun 06, 2014
UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, UNIPOLAR TEMPORARY ATRIAL PACING...
K140972 · LDF
Medtronic, Inc.
Cardiovascular · 51d
Cleared Jun 06, 2014
ENSITE VELOCITY SYSTEM
K141050 · DQK
St Jude Medical
Cardiovascular · 44d
Cleared Jun 06, 2014
CHORD-X PRE-MEASURED LOOPS FOR MITRAL CHORDAL REPLACEMENT
K141060 · PAW
On-X Life Technologies, Inc.
Cardiovascular · 43d
Cleared Jun 06, 2014
V2.7 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM
K141185 · DQK
Boston Scientific Corp
Cardiovascular · 30d
Cleared Jun 06, 2014
DR 400
K141192 · MQB
Agfa Healthcare N.V.
Radiology · 29d
Cleared Jun 05, 2014
ALADDIN
K131567 · HJO
Visia Imaging S.R.L.
Ophthalmic · 371d
Cleared Jun 05, 2014
U FIT DENTAL IMPLANT SYSTEM
K132956 · DZE
T Strong, Inc.
Dental · 258d
Cleared Jun 05, 2014
ENDOWRIST VESSEL SEALER
K140189 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 132d
Cleared Jun 05, 2014
HET SYSTEMS, LLC, HET BIPOLAR LIGATOR SYSTEM
K140422 · GEI
Het Systems, LLC
General & Plastic Surgery · 107d
Cleared Jun 05, 2014
MEDICAD CLASSIC
K140434 · LLZ
Hectec GmbH
Radiology · 105d
Cleared Jun 05, 2014
COLGATE DESENSITIZING MOUTHRINSE, COLGATE SENSITIVE PRO-RELIEF MOUTHWASH
K140481 · LBH
Colgate-Palmolive Company
Dental · 99d
Cleared Jun 05, 2014
BN LUMBAR CAGE SYSTEM
K140564 · MAX
Medyssey USA, Inc.
Orthopedic · 92d
Cleared Jun 05, 2014
FLASH PENTA MB QUICK, FLASH MB QUICK
K140602 · ELW
3M Espe AG
Dental · 87d
Cleared Jun 05, 2014
STRYKER KWIC NEEDLE
K140868 · HAW
Orthovita, Inc.
Neurology · 63d
Cleared Jun 05, 2014
STARCERAM
K140924 · EIH
H.C. Starck Ceramics GmbH
Dental · 55d
Cleared Jun 05, 2014
RSP HUMERAL SOCKET INSERT
K141006 · PHX
Djo Global
Orthopedic · 48d
Cleared Jun 05, 2014
LOGIQ S7 EXPERT, LOGIQ S7 PRO
K141261 · IYN
Ge Healthcare
Radiology · 21d
Cleared Jun 04, 2014
MOTEX POLYISOPRENE POWDER-FREE SURGICAL GLOVES MODEL # 6412(6432) AND #...
K123126 · KGO
Shanghai Motex Healthcare Co., Ltd.
General Hospital · 608d