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
43249–43272 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 19, 2012
MEB-2300A NEUROPACK EVOKED POTENTIAL AND EMG MEASURING SYSTEM
K120397 · GWF
Nihon Kohden Corp.
Neurology · 224d
Cleared Sep 19, 2012
WALK ON WHEELS HS-3500 ELECTRIC AISLE WHEELCHAIR
K120405 · ITI
Walk on Wheels Australia Pty, Ltd.
Physical Medicine · 223d
Cleared Sep 19, 2012
SLEEP PROFILER
K120450 · OLZ
Advanced Brain Monitoring, Inc.
Neurology · 218d
Cleared Sep 19, 2012
MERIT HYDROPHILIC GUIDE WIRE
K120644 · DQX
Merit Medical Systems, Inc.
Cardiovascular · 201d
Cleared Sep 19, 2012
MASIMO SET AND MASIMO RAINBOW SET PULSE OXIMETERS AND SENSORS
K120657 · DQA
Masimo Corporation
Anesthesiology · 198d
Cleared Sep 19, 2012
POWER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED)
K120968 · LYZ
Tangshan Zhonghong Pulin Plastic Co.,Ltd
General Hospital · 173d
Cleared Sep 19, 2012
METS MODULAR DISTAL FEMUR
K121029 · KRO
Stanmore Implants Worldwide , Ltd.
Orthopedic · 167d
Cleared Sep 19, 2012
METS MODULAR TOTAL FEMUR
K121055 · JDI
Stanmore Implants Worldwide , Ltd.
Orthopedic · 166d
Cleared Sep 19, 2012
GENESIS HEALTH TECHNOLOGIES BLOOD GLUCOSE MONITORING SYSTEM
K121224 · LFR
Taidoc Technology Corporation
Chemistry · 152d
Cleared Sep 19, 2012
BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM
K121302 · HRS
Biomet Microfixation
Orthopedic · 141d
Cleared Sep 19, 2012
VITASCAN LT SCANMASTER
K121689 · IYO
Vitacon Medical, Inc.
Radiology · 104d
Cleared Sep 19, 2012
PENUMBRA EMBOLECTOMY ASPIRATION SYSTEM
K121917 · QEW
Penumbra, Inc.
Cardiovascular · 79d
Cleared Sep 19, 2012
VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST
K122514 · PAM
Nanosphere, Inc.
Microbiology · 33d
Cleared Sep 19, 2012
MYOSURE XL ROD LENS HYSTEROSCOPE, MYOSURE XL OUTLFOW CHANNEL
K122563 · HIH
Hologic, Inc.
Obstetrics & Gynecology · 28d
Cleared Sep 19, 2012
ENDURAMESH
K122622 · MQP
Lucero Medical, LLC
Orthopedic · 22d
Cleared Sep 18, 2012
BICERA (TM) RESORBABLE BONE SUBSTITUTE
K110949 · MQV
Wiltrom Corporation Limited
Orthopedic · 533d
Cleared Sep 18, 2012
SCKOONCUP
K120107 · HHE
Sckoon, Inc.
Obstetrics & Gynecology · 249d
Cleared Sep 18, 2012
ISIGHT
K121519 · LPL
C&E GP Specialists, Inc.
Ophthalmic · 119d
Cleared Sep 18, 2012
NEPHROMAX HIGH PRESSURE NEPHROSTOMY BALOON DILATATION CATHETER
K121614 · LJE
Boston Scientific Corp
Gastroenterology & Urology · 109d
Cleared Sep 18, 2012
BD VERITOR(TM) SYSTEM FOR THE RAPID DETECTION OF RSV
K121633 · GQG
Becton, Dickinson and Company
Microbiology · 106d
Cleared Sep 18, 2012
CLYDESDALE SPINAL SYSTEM
K122591 · MAX
Medtronic Sofamor Danek, Inc.
Orthopedic · 25d
Cleared Sep 17, 2012
KMC KYPHOPLASTY SYSTEM
K113742 · NDN
Shanghai Kinetic Medical Co., Ltd.
Orthopedic · 272d
Cleared Sep 17, 2012
MODEL FAMILY OF AEROLASE ND:YAG LASERS: FRIENDLYLIGHT ND: YAG LASERS,...
K120235 · GEX
Aerolase Medical Lasers, LLC
General & Plastic Surgery · 236d
Cleared Sep 17, 2012
DIGNITY POWER INJECTABLE TITANIUM PORT
K120281 · LJT
Medical Components, Inc.
General Hospital · 230d