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
57505–57528 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 31, 2008
RESUSCITATION TIMER, MODEL L770-CPR
K073171 · BTM
Allied Healthcare Products, Inc.
Anesthesiology · 83d
Cleared Jan 31, 2008
ACCIN ANTERIOR CERVICAL PLATE SYSTEM
K073530 · KWQ
Accelerated Innovation, LLC
Orthopedic · 45d
Cleared Jan 31, 2008
PROVISA CEM
K073539 · EMB
Cavex Holland BV
Dental · 45d
Cleared Jan 31, 2008
18 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION...
K073559 · DQR
Edwards Lifesciences Research Medical
Cardiovascular · 43d
Cleared Jan 31, 2008
MODIFICATION TO PROXIS SYSTEM
K073563 · NFA
St Jude Medical
Cardiovascular · 43d
Cleared Jan 31, 2008
CYNOSURE SMARTLIPO MULTIWAVLENGTH LASER
K080121 · GEX
Cynosure, Inc.
General & Plastic Surgery · 14d
Cleared Jan 31, 2008
VENTRI 1.1
K080124 · KPS
Ge Medical Systems F.I. Haifa
Radiology · 14d
Cleared Jan 30, 2008
ALN OPTIONAL VENA CAVA FILTER-FEMORAL APPROACH, JUGULAR APPROACH, BRACHIAL...
K070514 · DTK
Aln Implants Chirurgicaux
Cardiovascular · 342d
Cleared Jan 30, 2008
HERO VASCULAR ACCESS DEVICE
K071778 · DSY
Graftcath, Inc.
Cardiovascular · 212d
Cleared Jan 30, 2008
VEINOPLUS NEUROMUSCULAR STIMULATOR
K072252 · IPF
Ad Rem Technology Sarl
Physical Medicine · 170d
Cleared Jan 30, 2008
MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVEL
K072257 · LAS
More Diagnostics
Toxicology · 170d
Cleared Jan 30, 2008
SOFTPAP CERVICAL CELL COLLECTOR
K072381 · HHT
Cytocore, Inc.
Obstetrics & Gynecology · 159d
Cleared Jan 30, 2008
PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPTER
K072538 · LNS
United Medical Systems, Inc.
Gastroenterology & Urology · 145d
Cleared Jan 30, 2008
LYOPHILIZED MULTIBLAST MEDIUM KIT
K072608 · MQL
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 135d
Cleared Jan 30, 2008
SOMNOMED BFLEX
K073004 · LRK
Somnomed, Inc.
Dental · 98d
Cleared Jan 30, 2008
SMALL LUMEN PERITONEAL CATHETER
K073139 · JXG
Medtronic Neurosurgery
Neurology · 84d
Cleared Jan 30, 2008
ARDIS SPACER
K073202 · MAX
Abbott Spine, Inc.
Orthopedic · 78d
Cleared Jan 30, 2008
ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM
K073267 · NKB
Endius, Inc.
Orthopedic · 71d
Cleared Jan 30, 2008
DEPUY ASR 300 ACETABULAR CUP SYSTEM
K073413 · KWA
DePuy Orthopaedics, Inc.
Orthopedic · 57d
Cleared Jan 30, 2008
WAVESENSE KEYNOTE CODELESS BLOOD GLUCOSE MONITORING SYSTEM
K073573 · NBW
Agamatrix
Chemistry · 41d
Cleared Jan 30, 2008
GELSPRAY WOUND DRESSING
K073663 · KMF
Biocure, Inc.
General & Plastic Surgery · 35d
Cleared Jan 30, 2008
AMS MINIARC SLING SYSTEM
K073703 · PAH
American Medical Systems, Inc.
Gastroenterology & Urology · 30d
Cleared Jan 30, 2008
GE DATEX-OHMEDA AISYS
K073707 · BSZ
Datex-Ohmeda, Inc.
Anesthesiology · 30d
Cleared Jan 29, 2008
ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY 17-A-HYDROXYPROGESTERONE
K062534 · JLX
Drg Intl., Inc.
Chemistry · 518d