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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
55609–55632 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 12, 2008
NEOSALUS
K070309 · FRO
Quinnova Pharmaceuticals
General & Plastic Surgery · 589d
Cleared Sep 12, 2008
SAVE RESUSCITATOR
K073410 · BTM
Artivent Corporation
Anesthesiology · 283d
Cleared Sep 12, 2008
FISHER AND PAYKEL HEALTHCARE ZEST NASAL MASK
K080209 · BZD
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 228d
Cleared Sep 12, 2008
ROTA FLOW CENTRIFUGAL PUMP WITH BIOLINE COATING, MODELS BE-RF-32, BEQ-RF-32
K080470 · KFM
Maquet Cardiopulmonary, AG
Cardiovascular · 204d
Cleared Sep 12, 2008
YEAST TRAFFIC LIGHT PNA FISH
K080719 · JXB
Advandx, Inc.
Microbiology · 183d
Cleared Sep 12, 2008
SLEEPSTYLE 200 AUTO SERIES HC254
K081029 · BZD
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 154d
Cleared Sep 12, 2008
SIMPACT IMPLANT SYSTEM
K081226 · DZE
Simpact, LLC
Dental · 135d
Cleared Sep 12, 2008
ABX PENTRA GLUCOSE HK CP, ABX PENTRA URIC ACID CP, ABX PENTRA URINE CONTROL L/H
K081276 · CFR
Horiba Abx
Chemistry · 130d
Cleared Sep 12, 2008
BIVONA ADJUSTABLE AND FIXED NECKFLANGE HYPERFLEX TRACHEOSTOMY TUBES
K081440 · JOH
Smiths Medical Asd, Inc.
Anesthesiology · 113d
Cleared Sep 12, 2008
KEGEL8 PELVIC EXERCISER, MODEL OPH 400
K081480 · KPI
Ne Services , Ltd.
Gastroenterology & Urology · 108d
Cleared Sep 12, 2008
DYNAREX/TILLOTSON NON-STERILE POWDER FREE BLUE NITRILE PATIENT EXAM GLOVE FOR...
K081569 · LZA
Dynarex Corporation
General Hospital · 100d
Cleared Sep 12, 2008
DENJECTOR
K081694 · EJI
Dxm Co., Ltd.
Dental · 87d
Cleared Sep 12, 2008
FINGERTIP PULSE OXIMETER, MODEL M70, AND HANDHELD PULSE OXIMETER, MODEL M700
K081712 · DQA
Guangdong Biolight Meditech Co., Ltd.
Anesthesiology · 87d
Cleared Sep 12, 2008
SOLX 790 TITANIUM SAPPHIRE LASER
K081774 · HQF
Solx, Inc.
Ophthalmic · 81d
Cleared Sep 12, 2008
NS SERIES VACUUM/PRESSURE GAUGES, CUFF PRESSURE MONITORS
K081778 · CAP
Instrumentation Industries, Inc.
Anesthesiology · 81d
Cleared Sep 12, 2008
21.3-INCH (54CM) MONOCHROME LCD MONITOR MS21I2 (MDL2127A)
K081945 · LLZ
Totoku Electric Co., Ltd.
Radiology · 66d
Cleared Sep 12, 2008
STARLIGHT
K081994 · OAN
Orthomerica Products, Inc.
Neurology · 60d
Cleared Sep 12, 2008
CONTURA LUMEN MARKER
K082264 · JAQ
Senorx, Inc.
Radiology · 32d
Cleared Sep 12, 2008
PRIME ECG SYSTEM (WITH ENHANCED DIAGNOSTIC ALGORITHM)
K082312 · DPS
Heartscape Technologies, Ltd.
Cardiovascular · 30d
Cleared Sep 12, 2008
TRUFILL DCS SYRINGE
K082324 · HCG
Cordis Neurovascular, Inc.
Neurology · 29d
Cleared Sep 12, 2008
MODIFICATION TO CAPSTONE SPINAL SYSTEM
K082342 · MAX
Medtronic Sofamor Danek
Orthopedic · 28d
Cleared Sep 12, 2008
CARDIUS-1, -2, -3, AND CARDIUS 1,2,3 XPO SPECT IMAGING SYSTEMS, 2020TC SPECT...
K082368 · KPS
Digirad Corp.
Radiology · 25d
Cleared Sep 12, 2008
QUANTRA
K082483 · LLZ
Hologic, Inc.
Radiology · 15d
Cleared Sep 12, 2008
ACCELAWAVE SYSTEM
K082484 · ONF
Genesis Biosystems, Inc.
General & Plastic Surgery · 15d