FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
25057–25080 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 30, 2018
Arthrex PushLock Tenodesis Anchor
K181513 · MBI
Arthrex, Inc.
Orthopedic · 83d
Cleared Aug 30, 2018
Swiss LithoClast Trilogy
K181997 · FEO
E.M.S Electro Medical Systems S.A
Gastroenterology & Urology · 35d
Cleared Aug 30, 2018
Dissecting Balloon System
K182024 · GCJ
Applied Medical Resources Corp.
General & Plastic Surgery · 31d
Cleared Aug 29, 2018
REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement
K172906 · KWL
Osteoremedies, LLC
Orthopedic · 341d
Cleared Aug 29, 2018
Equinox Advantage
K173205 · BZR
O-Two Medical Technologies, Inc.
Anesthesiology · 331d
Cleared Aug 29, 2018
Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set
K180073 · MQL
Shenzhen Vitavitro Bio-Tech Co., Ltd.
Obstetrics & Gynecology · 232d
Cleared Aug 29, 2018
TruClear Elite Hysteroscope
K180496 · HIH
Covidien
Obstetrics & Gynecology · 184d
Cleared Aug 29, 2018
Geister retractor for neuro - and spine surgery
K180610 · GZT
Geister Medizin Technik GmbH
General & Plastic Surgery · 174d
Cleared Aug 29, 2018
Meta P&Bond
K180802 · KLE
Meta Biomed Co., Ltd.
Dental · 154d
Cleared Aug 29, 2018
Arm type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic...
K181104 · DXN
Shenzhen Combei Technology Co., Ltd.
Cardiovascular · 125d
Cleared Aug 29, 2018
Change Healthcare Enterprise Viewer
K181185 · LLZ
Change Healthcare Canada Company
Radiology · 118d
Cleared Aug 29, 2018
Genesys Spine AIS-C Cervical Stand-Alone System
K181295 · OVE
Genesys Spine
Orthopedic · 105d
Cleared Aug 29, 2018
ACCUFUSE Cervical System
K181471 · ODP
Absolute Advantage Medical, LLC
Orthopedic · 86d
Cleared Aug 29, 2018
Zio AT ECG Monitoring System, ZEUS System
K181502 · DQK
iRhythm Technologies, Inc.
Cardiovascular · 83d
Cleared Aug 29, 2018
ZELTIQ CoolSculpting System
K181740 · OOK
Zeltiq Aesthetics, Inc.
General & Plastic Surgery · 58d
Cleared Aug 29, 2018
ResCUBE™ Ligament Fixation System
K181799 · OWI
Cousin Biotech Sas
Orthopedic · 55d
Cleared Aug 29, 2018
Natrelle 133S Tissue Expander
K182054 · LCJ
Allergan
General & Plastic Surgery · 29d
Cleared Aug 29, 2018
CD HORIZON™ Spinal System
K182119 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 23d
Cleared Aug 28, 2018
Universal SmartECG
K173952 · DPS
Vectracor, Inc.
Cardiovascular · 244d
Cleared Aug 28, 2018
Disposable Insulin Pen Needle
K181069 · FMI
Zhejiang Kindly Medical Devices Co.,...
General Hospital · 127d
Cleared Aug 28, 2018
Tenex Health TX System with the TXP MicroTip
K181367 · LFL
Tenex Health, Inc.
General & Plastic Surgery · 97d
Cleared Aug 28, 2018
BD MAX CT/GC/TV 20-Day QC Panel
K181683 · PMN
Microbiologics, Inc.
Microbiology · 63d
Cleared Aug 27, 2018
BenQ Diagnostic Ultrasound System
K181313 · IYN
Qisda Corporation
Radiology · 102d
Cleared Aug 27, 2018
JO Classic Hybrid Personal Lubricant
K181408 · NUC
United Consortium
Obstetrics & Gynecology · 89d