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
36577–36600 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 20, 2014
Xario 200, V3.0
K143027 · IYN
Toshibamedical Systems Corporation
Radiology · 30d
Cleared Nov 20, 2014
Gel-Block 10X embolization pledgets
K143038 · KRD
Vascular Solutions, Inc.
Cardiovascular · 29d
Cleared Nov 20, 2014
MaxZero Administration Sets
K143234 · FPA
Care Fusion
General Hospital · 10d
Cleared Nov 19, 2014
PANTEX SALIVARY DIRECT TESTOSTERONE EIA KIT, Pantex Sample Collection Device
K133303 · JKA
Bio-Analysis, Inc.
Chemistry · 390d
Cleared Nov 19, 2014
ECVUE MAPPING SYSTEM
K140497 · DQK
Cardioinsight Technologies, Inc.
Cardiovascular · 265d
Cleared Nov 19, 2014
ANTEGRADE CARDIOPLEGIA CANNULA(N-TYPE)
K140569 · DWF
Maquet Cardiopulmonary, AG
Cardiovascular · 258d
Cleared Nov 19, 2014
CENTERCROSS CATHETER
K140910 · DQY
Roxwood Medical, Inc.
Cardiovascular · 224d
Cleared Nov 19, 2014
FM-3000 FETAL MONITOR
K141194 · HGM
Advanced Instrumentations, Inc.
Obstetrics & Gynecology · 195d
Cleared Nov 19, 2014
TOGGLELOC AND JUGGERLOC IMPLANTS/INSTRUMENTS/KITS
K141263 · JDR
Biomet Manufacturing Corp
Orthopedic · 188d
Cleared Nov 19, 2014
VARIA-NCI
K141462 · IYN
Neurochaos Solutions, Inc.
Radiology · 169d
Cleared Nov 19, 2014
AUTOMATICALLY RETRACTABLE SAFETY SYRINGES WITH FIXED NEEDLE
K141640 · MEG
Shantou Wealy Medical Instrument Co.,Ltd
General Hospital · 153d
Cleared Nov 19, 2014
ARM-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
K141755 · DXN
Sejoy Electronics & Instruments Co.,...
Cardiovascular · 142d
Cleared Nov 19, 2014
ZOLL X SERIES
K141774 · MKJ
ZOLL Medical Corporation
Cardiovascular · 140d
Cleared Nov 19, 2014
ENDO-MARYLAND DISSECTOR
K141794 · KGE
Ovesco Endoscopy AG
Gastroenterology & Urology · 140d
Cleared Nov 19, 2014
MORTARA MONITORING WAVEFORM VIEWER
K141811 · MHX
Mortara Instrument, Inc.
Cardiovascular · 135d
Cleared Nov 19, 2014
MAGNETOM AERA WITH SOFTWARE SYNGO MR E11A, MAGNETOM SKYRA WITH SOFTWARE SYNGO...
K141977 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 121d
Cleared Nov 19, 2014
EXPEDIUM VERSE SPINE SYSTEM
K142185 · NKB
Depuy Spine, Inc.
Orthopedic · 103d
Cleared Nov 19, 2014
AVS AS PEEK Spacer
K142251 · ODP
Stryker Corporation
Orthopedic · 97d
Cleared Nov 19, 2014
DualCap IV Pole Strips(Disinfectant Caps for Male Luers)
K142399 · QBP
Catheter Connections, Inc.
General Hospital · 84d
Cleared Nov 19, 2014
Reline System
K142499 · NKB
Nu Vasive, Incorporated
Orthopedic · 75d
Cleared Nov 19, 2014
UltraHealth Hybrid Contact Lens for Keratoconus, UltraHealth Flat Cornea...
K142510 · HQD
Synergeyes, Inc.
Ophthalmic · 72d
Cleared Nov 19, 2014
VIAL-MATE Adaptor
K142600 · LHI
Baxter Healthcare Corporation
General Hospital · 65d
Cleared Nov 19, 2014
EVac 70 Xtra Plasma Wand with Integrated Cable, PROcise XP Plasma Wand with...
K142999 · GEI
ArthroCare Corporation
General & Plastic Surgery · 33d
Cleared Nov 19, 2014
Xario 100, V3.0
K143046 · IYN
Toshibamedical Systems Corporation
Radiology · 28d