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
45385–45408 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 20, 2012
GPSCATH BALLON DILATATION CATHETER
K113769 · LIT
Hotspur Technologies
Cardiovascular · 29d
Cleared Jan 20, 2012
QUILL QUADRAHELIX TISSUE-CLOSURE DEVICE
K113800 · GAW
Angiotech
General & Plastic Surgery · 28d
Cleared Jan 19, 2012
CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and...
K111157 · OBO
Carl Zeiss Meditec, Inc.
Ophthalmic · 269d
Cleared Jan 19, 2012
HISTOBRUSH
K111681 · HHT
Puritan Medical Products Company, LLC
Obstetrics & Gynecology · 218d
Cleared Jan 19, 2012
OASYS SPINAL SYSTEM
K111719 · KWP
Stryker Spine
Orthopedic · 213d
Cleared Jan 19, 2012
KIMGUARD SMART-FOLD* STERILIZATION WRAP
K112300 · FRG
Kimberly-Clark Corp.
General Hospital · 162d
Cleared Jan 19, 2012
RS-4I MUSCLE STIMULATOR
K112348 · IPF
Rs Medical
Physical Medicine · 156d
Cleared Jan 19, 2012
DREAMGARD REM-SOFT, DREAMGARD REM-LITE, DREAMGARD REM-ULTRA, DREAMGARD REM-MAX
K112868 · MQC
Dreamgard, Inc.
Dental · 111d
Cleared Jan 19, 2012
TRULY AUTOMATIC ARM BLOOD PRESSURE MONITOR
K113083 · DXN
Truly Instrument Co., Ltd.
Cardiovascular · 93d
Cleared Jan 19, 2012
NANOVIS SPINAL SYSTEM
K113173 · NKB
Nanovis, LLC
Orthopedic · 84d
Cleared Jan 19, 2012
MEGABEAM ENDOCULAR PROBE AND ASPIRATING ENDOCULAR PROBE
K113792 · GEX
Biolitec Medical Devices, Inc.
General & Plastic Surgery · 27d
Cleared Jan 19, 2012
CABLE/ LEAD-WIRE (ECG, EKG, SPO2 AND INVASIVE BLOOD PRESSURE)
K120010 · DSA
Shenzhen Med-Link Electronics Tech...
Cardiovascular · 16d
Cleared CT Jan 18, 2012
AG-608N BLOOD GLUCOSE MONITORING SYSTEM
K110017 · NBW
Andon Medical Co., Ltd.
Chemistry · 380d
Cleared Jan 18, 2012
MISSION U500 URINE ANALYZER
K111221 · JIO
ACON Laboratories, Inc.
Chemistry · 261d
Cleared Jan 18, 2012
QUASAR CALYPSO
K111286 · OLP
Silver Bay, LLC
General & Plastic Surgery · 257d
Cleared Jan 18, 2012
TRIPORT, TRIPORT+, TRIPORT15, QUADPORT
K111407 · OTJ
Advanced Surgical Concepts
General & Plastic Surgery · 244d
Cleared Jan 18, 2012
HANDHELD PULSE OXIMETER
K111494 · DQA
Beijing Choice Electronic Technololgy...
Anesthesiology · 232d
Cleared Jan 18, 2012
POWDER FREE LATEX PATIENT EXAMINATION GLOVE, WITH PROTEIN CONTENT LABELING CLAIM
K112612 · LYY
Top Calibre Sdn Bhd
General Hospital · 133d
Cleared Jan 18, 2012
AVITA ARM TYPE BLOOD PRESSURE MONITOR
K112825 · DXN
Avita Corporation
Cardiovascular · 112d
Cleared Jan 18, 2012
ST JUDE MEDICAL, IS4 FLUSHING/FUNNELING TOOL
K113773 · KRA
St Jude Medical
Cardiovascular · 27d
Cleared Jan 17, 2012
COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM
K112441 · IRP
Daesung Maref Co., Ltd.
Physical Medicine · 146d
Cleared Jan 17, 2012
OSTEON II
K112716 · LYC
Genoss Co., Ltd.
Dental · 120d
Cleared Jan 17, 2012
CUFFINK
K112814 · MBI
Cayenne Medical, Inc.
Orthopedic · 112d
Cleared Jan 17, 2012
AUTOSURE VOICE II PLUS, AUTOSURE PLUS BLOOD GLUCOSE TEST STRIPS,CONTREX PLUS III
K113098 · NBW
Apex BioTechnology Corp.
Chemistry · 90d