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

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175,820 results
34633–34656 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 06, 2015
HemosIL D-Dimer HS
K151534 · DAP
Instrumentation Laboratory CO
Hematology · 28d
Cleared Jul 02, 2015
AUTOMATIC BLOOD PRESSURE MONITOR
K140762 · DXN
Jawon Medical Co., Ltd.
Cardiovascular · 462d
Cleared Jul 02, 2015
PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT
K141965 · DWM
Care Fusion
Anesthesiology · 346d
Cleared Jul 02, 2015
ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator Set
K143075 · CDZ
Tosoh Bioscience, Inc.
Chemistry · 248d
Cleared Jul 02, 2015
Theranos Herpes Simplex Virus-1 IgG Assay
K143236 · MXJ
Theranos, Inc.
Microbiology · 232d
Cleared Jul 02, 2015
Arthrex Corkscrew and SwiveLock Suture Anchors
K143745 · MBI
Arthrex, Inc.
Orthopedic · 183d
Cleared Jul 02, 2015
MicroScan Dried Gram Positive MIC/Combo Panels with vancomycin (0.25-64 mcg/mL)
K150039 · LTT
Siemens Healthcare Diagnostics, Inc.
Microbiology · 174d
Cleared Jul 02, 2015
Biodenta Customized Abutment-Hybrid
K150296 · NHA
Biodenta Swiss AG
Dental · 146d
Cleared Jul 02, 2015
3M Comply Indicator Tape for Ethylene Oxide (EO) Sterilization
K150477 · JOJ
3M Company
General Hospital · 128d
Cleared Jul 02, 2015
STRATAFIX Spiral PDS Plus Knotless Tissue Control Device
K150670 · NEW
Ethicon, Inc.
General & Plastic Surgery · 108d
Cleared Jul 02, 2015
LTM-Perforated Surgical Mesh
K150712 · FTM
Lifecell Corporation
General & Plastic Surgery · 105d
Cleared Jul 02, 2015
Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 Spray
K150750 · EGS
Sirona Dental Systems GmbH
Dental · 101d
Cleared Jul 02, 2015
Admira Fusion
K150784 · EBF
Voco GmbH
Dental · 99d
Cleared Jul 02, 2015
BruxZir Anterior Milling Blanks
K150872 · EIH
Prismatik Dentalcraft, Inc.
Dental · 92d
Cleared Jul 02, 2015
SpeediCath Compact Eve
K150935 · GBM
Coloplast A/S
Gastroenterology & Urology · 86d
Cleared Jul 02, 2015
ECVUE Mapping System
K150990 · DQK
Cardioinsight Technologies, Inc.
Cardiovascular · 78d
Cleared Jul 02, 2015
Tosama 100% Organic Cotton Menstrual Tampon
K151170 · HEB
Tosama, D.O.O.
Obstetrics & Gynecology · 62d
Cleared Jul 02, 2015
CARDIOSAVE Hybrid Intra-Aortic Balloon Pump
K151254 · DSP
Datascope Corp.
Cardiovascular · 51d
Cleared Jul 02, 2015
VersaOne Bladed Trocar, VersaOne Bladeless Trocar
K151548 · GCJ
Covidien
General & Plastic Surgery · 23d
Cleared Jul 01, 2015
SILKPRO laser hair removal system
K142845 · OHT
Wuhan Lotuxs Technology Co., Ltd.
General & Plastic Surgery · 274d
Cleared Jul 01, 2015
Magellan Robotic System, Magellan Robotic Catheter 10Fr
K143227 · DXX
Hansen Medical, Inc.
Cardiovascular · 233d
Cleared Jul 01, 2015
CastleLoc-P Anterior Cervical Plate System
K143271 · KWQ
L & K Biomed Co., Ltd.
Orthopedic · 230d
Cleared Jul 01, 2015
ASFORA ANTERIOR CERVICAL PLATE SYSTEM
K143688 · KWQ
Medical Designs, LLC
Orthopedic · 189d
Cleared Jul 01, 2015
SculpSure
K150724 · PKT
Cynosure, Inc.
General & Plastic Surgery · 103d