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
43513–43536 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 20, 2012
VASOPRESS DVT LEG GARMENTS (STERILE) VASOPRESS DVT FOOT GARMENTS (STERILE)
K122179 · JOW
Compression Therapy Concepts
Cardiovascular · 28d
Cleared Aug 17, 2012
CALAVIEW COLOR (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR...
K112373 · LPL
Innova Vision, Inc.
Ophthalmic · 366d
Cleared Aug 17, 2012
MICROAIRE SURGICAL INSTRUMENTS LLC
K113128 · QPB
Microaire Surgical Instruments, LLC
General & Plastic Surgery · 298d
Cleared Aug 17, 2012
LUNG VOLUME ANALYSIS
K113715 · JAK
Toshibamedical Systems Corporation
Radiology · 242d
Cleared Aug 17, 2012
HITACHI CLINICAL ANALYZER S TEST REGENT CARTRIDGE C-REACTIVE PROTEIN (CRP)
K113809 · DCN
Hitachi Chemical Diagnostics, Inc.
Immunology · 238d
Cleared Aug 17, 2012
MEDLINE HIGH PRESSURE INJECTION TUBING
K120008 · DQO
Medline Industries, Inc.
Cardiovascular · 227d
Cleared Aug 17, 2012
TAPERLOC COMPLETE SIZE 4MM AND XR 123
K120030 · LPH
Biomet Manufacturing Corp
Orthopedic · 226d
Cleared Aug 17, 2012
NEBULAE I
K120151 · HIF
Northgate Technologies, Inc.
Obstetrics & Gynecology · 212d
Cleared Aug 17, 2012
POWDER-FREE NITRIE EXAMINATION GLOVES, ORANGE
K120890 · LZA
Shen Wei (Usa), Inc.
General Hospital · 147d
Cleared Aug 17, 2012
YA HORNG BLOOD PRESSURE MONITOR, YA HORNG BLOOD PRESSURE MONITOR, BLUETOOTH...
K121025 · DXN
Ya Horng Electronic Co., Ltd.
Cardiovascular · 135d
Cleared Aug 17, 2012
VIVID I DIAGNOSTIC ULTRASOUND SYSTEM, VIVID Q DIAGNOSTIC ULTRASOUND SYSTEM
K121062 · ITX
Ge Medical System Israel , Ltd.
Radiology · 133d
Cleared Aug 17, 2012
STGC
K121176 · MQP
Cardinal Spine, LLC
Orthopedic · 121d
Cleared Aug 17, 2012
VENOFER PUMP
K121497 · KDI
Renal Solutions, Inc.
Gastroenterology & Urology · 88d
Cleared Aug 17, 2012
A-V FOOT PUMP
K121718 · JOW
Dalian Labtek Science & Development...
Cardiovascular · 67d
Cleared Aug 17, 2012
OCTAVE SPEEDER HEAD
K121910 · MOS
Toshiba Medical Systems Corporation,...
Radiology · 49d
Cleared Aug 17, 2012
OCTAVE SPEEDER SPINE
K121911 · MOS
Toshiba Medical Systems Corporation,...
Radiology · 49d
Cleared Aug 17, 2012
ATRIUM FLIXENE IFG VASCULAR GRAFT
K122138 · DSY
Atrium Medical Corp.
Cardiovascular · 29d
Cleared Aug 17, 2012
LANX SPINAL FIXATION SYSTEM
K122145 · NKB
Lanx, Inc.
Orthopedic · 29d
Cleared Aug 17, 2012
PRELUDE 7F SHORT SHEATH INTRODUCER
K122190 · DYB
Merit Medical Systems, Inc.
Cardiovascular · 24d
Cleared Aug 17, 2012
TRUETOME
K122203 · KNS
Boston Scientific Corp
Gastroenterology & Urology · 23d
Cleared Aug 16, 2012
WITOUCH PRO
K120398 · GZJ
Hollywog, LLC
Neurology · 190d
Cleared Aug 16, 2012
STRATIFY JCV DXSELECT
K120986 · OYP
Focus Diagnostics, Inc.
Microbiology · 136d
Cleared Aug 16, 2012
DX-D IMAGING PACKAGE
K121095 · MQB
Agfa Healthcare N.V.
Radiology · 127d
Cleared Aug 16, 2012
CHORD-X EPTFE SUTURE
K121173 · PAW
On-Xlifetechnologies
Cardiovascular · 121d