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
68089–68112 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 14, 2004
LIGHT AGE EPICARE ALEXANDRITE LASER, MODELS 501-1H, 501-SP, 501-LP AND 501-LPX
K032991 · GEX
Light Age, Inc.
General & Plastic Surgery · 355d
Cleared Sep 14, 2004
TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING
K040392 · HFM
American I.V. Products, Inc.
Obstetrics & Gynecology · 210d
Cleared Sep 14, 2004
PEDIATRIC ENERGY REDUCER, MODELS AED-10 AND AED-20
K040479 · MKJ
Welch Allyn, Inc.
Cardiovascular · 202d
Cleared Sep 14, 2004
ATRIUM MEDICAL CORPORATION ICAST COVERED STENT
K041269 · JCT
Atrium Medical Corp.
General & Plastic Surgery · 125d
Cleared Sep 14, 2004
EP-4 CLINICAL STIMUTATOR
K041442 · JOQ
Ep Medsystems
Cardiovascular · 105d
Cleared Sep 14, 2004
FLEXI-STAT DISPOSABLE ADHESIVE SPO2 SENSORS
K041522 · DQA
Elekon Industries U.S.A., Inc.
Anesthesiology · 99d
Cleared Sep 14, 2004
MODIFICATION TO EPTFE GRAFT
K041528 · DSY
Vascutek, Ltd.
Cardiovascular · 98d
Cleared Sep 14, 2004
TWIN STAR COMPARTMENT SYNDROME PRESSURE MONITORING AND FLUID COLLECTION...
K041771 · LXC
Twin Star Medical, Inc.
Orthopedic · 76d
Cleared Sep 14, 2004
MODIFICATION TO OPTICAL SEPARATOR SYSTEM
K041795 · GCJ
Applied Medical Resources Corp.
General & Plastic Surgery · 74d
Cleared Sep 14, 2004
MEDIAID REUSABLE FINGER CLIP SPO2 SENSORS AND DISPOSABLE NON-ADHESIVE SENSORS...
K041964 · DQA
Mediaid, Inc.
Anesthesiology · 55d
Cleared Sep 14, 2004
VITEK 2 GRAM NEGATIVE ERTAPENEM
K041982 · LON
bioMerieux, Inc.
Microbiology · 53d
Cleared Sep 14, 2004
ZOE FLUID STATUS MONITOR
K042113 · DSB
Noninvasive Medical Technologies, LLC
Cardiovascular · 40d
Cleared Sep 14, 2004
DAPTOMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K042157 · JTN
Oxoid , Ltd.
Microbiology · 35d
Cleared Sep 14, 2004
SOMATOM SPIRIT
K042328 · JAK
Siemens Medical Systems, Inc.
Radiology · 18d
Cleared Sep 14, 2004
MODIFICATION TO PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL...
K042389 · JJY
Roche Diagnostics Corp.
Chemistry · 12d
Cleared Sep 13, 2004
MONORAIL
K040143 · DZE
Nats Corp.
Dental · 235d
Cleared Sep 13, 2004
LITEPORT LP100 SURGICAL ILLUMINATOR
K041621 · FTF
Medical Vision Industries, Inc.
General & Plastic Surgery · 89d
Cleared Sep 13, 2004
INFRARED EAR THERMOMETER, ET-100 SERIES
K041692 · FLL
Hangzhou Hua'An Medical & Health...
General Hospital · 83d
Cleared Sep 13, 2004
DIGITAL FLEXIBLE THERMOMETER, BASIC DIGITAL THERMOMETER, DITITAL PACIFIER...
K041694 · FLL
Hangzhou Hua'An Medical & Health...
General Hospital · 83d
Cleared Sep 13, 2004
RAVEN PROTEST - EO
K041784 · FRC
Raven Biological Laboratories, Inc.
General Hospital · 74d
Cleared Sep 13, 2004
SAFE T RETRACTABLE BLOOD COLLECTION DEVICE
K041941 · FMI
Safe T Medical Devices, Ltd.
General Hospital · 56d
Cleared Sep 10, 2004
SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR HIP APPLICATIONS
K033341 · HAW
Smith & Nephew, Inc.
Neurology · 329d
Cleared Sep 10, 2004
BD FACS 7-COLOR SETUP BEADS
K040026 · GKZ
Becton Dickinson Immunocytometry Systems
Hematology · 247d
Cleared Sep 10, 2004
PULSEOX 5500 FINGER DEVICE, PULSEOX 7500 WRISTWATCH DEVICE
K040178 · DQA
S.P.O. Medical Equipment, Ltd.
Anesthesiology · 228d