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
57121–57144 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 18, 2008
5MM PROTEGE EVERFLEX SELF EXPANDING BILIARY STENT SYSTEM, MODEL PRP35-05
K072301 · FGE
Ev3, Inc.
Gastroenterology & Urology · 214d
Cleared Mar 18, 2008
EVIS EXERA II 180 SYSTEM
K072957 · NWB
Olympus Medical Systems Corporation
Gastroenterology & Urology · 151d
Cleared Mar 18, 2008
MUSCLE PAIN DEVICE (MPD)
K073361 · IPF
Stevens Proof of Concept, Inc.
Physical Medicine · 109d
Cleared Mar 18, 2008
DRIVE SOLSTICE OXYGEN CONCENTRATOR
K080391 · CAW
Medical Depot
Anesthesiology · 34d
Cleared Mar 18, 2008
HENKE SASS WOLF OF AMERICA ARTHROSCOPE
K080560 · HRX
Henke Sass Wolf of America, Inc.
Orthopedic · 19d
Cleared Mar 17, 2008
AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLS
K072686 · LCP
Axis-Shield Diagnostics, Ltd.
Chemistry · 175d
Cleared Mar 17, 2008
SPINAL SPHERE SYSTEM
K073274 · NVR
Life Spine
Orthopedic · 117d
Cleared Mar 17, 2008
SUTTER ELECTROSURGICAL CABLES
K073450 · GEI
Sutter Medizintechnik GmbH
General & Plastic Surgery · 98d
Cleared Mar 14, 2008
IPUP 200 (INTELLIGENT PRESSURE ULCER PREVENTION)
K063175 · MOC
Medical Technology Systems, Inc.
Physical Medicine · 512d
Cleared Mar 14, 2008
QUANTITATIVE NEUROQ 3.0
K072307 · KPS
Syntermed, Inc.
Radiology · 210d
Cleared Mar 14, 2008
AMT INITIAL PLACEMENT GI KIT (E2418) AND AMT DILATOR SET (E2419)
K073034 · KNT
Applied Medical Technology, Inc.
Gastroenterology & Urology · 140d
Cleared Mar 14, 2008
APIERON INSIGHT EXHALED NITRIC OXIDE (ENO) SYSTEM
K073265 · MXA
Apieron, Inc.
Chemistry · 115d
Cleared Mar 14, 2008
EARPOPPER, MODEL EP-2000, EP-2100, EP-3000
K073401 · MJV
Micromedics, Inc.
Ear, Nose, Throat · 101d
Cleared Mar 14, 2008
NOCC HYDROPHILIC WOUND DRESSING
K080010 · KGN
Kytogenics, Inc.
General & Plastic Surgery · 71d
Cleared Mar 14, 2008
RX DC X-RAY UNIT
K080076 · EHD
Cefla S.C.R.L.
Radiology · 63d
Cleared Mar 14, 2008
OCCLUFAST CAD
K080130 · ELW
Zhermack S.P.A.
Dental · 56d
Cleared Mar 14, 2008
MODEL TSX-101A/H/I AQUILION 32/64 SP CT SYSTEM
K080211 · JAK
Toshiba America Medical Systems, In.C
Radiology · 45d
Cleared Mar 14, 2008
SUB-TALAR LOK, MODEL 7-11 MM
K080280 · HWC
Instratek, Inc.
Orthopedic · 39d
Cleared Mar 13, 2008
INPLEX CF MOLECULAR TEST
K063787 · NUA
Third Wave Technologies, Inc.
Pathology · 448d
Cleared Mar 13, 2008
AEMED STIMPAD ACU-TENS TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR, MODEL 021999
K071120 · GZJ
Aemed, Inc.
Neurology · 328d
Cleared Mar 13, 2008
ST. JUDE MEDICAL, CPS DUO LEFT HEART LEAD DELIVERY SYSTEM
K072864 · DRB
St. Jude Medical, Cardiac Rhythm...
Cardiovascular · 160d
Cleared Mar 13, 2008
LIISA LEVER INTEGRATED INTERVENTIONAL SYSTEM ADAPTER, MODEL VSL-109
K073260 · DTL
Device Partners International
Cardiovascular · 114d
Cleared Mar 13, 2008
PREVADH MESH
K073287 · FTL
Sofradim Production
General & Plastic Surgery · 113d
Cleared Mar 13, 2008
MEDTRONIC PROFILE 3D ANNULOPLASTY RING, MODEL 680R
K073324 · KRH
Medtronic, Inc.
Cardiovascular · 107d