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
44233–44256 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 29, 2012
SI-FIX SACROILIAC JOINT FUSION SYSTEM
K110472 · OUR
Medtronic Sofamor Danek
Orthopedic · 466d
Cleared May 29, 2012
HANSEN MEDICAL VASCULAR CATHETER CONTROL SYSTEM AND CATHETER
K111004 · DXX
Hansen Medical, Inc.
Cardiovascular · 414d
Cleared May 29, 2012
TM ARDIS INTERBODY SYSTEM TM ARDIS INTERBODY SYSTEM INSTRUMENATION
K113561 · MAX
Zimmer Trabecular Metal Technology
Orthopedic · 180d
Cleared May 29, 2012
ORTHO SOLUTIONS TRAUMA PLATES FOR OSTEOSYSNTHESIS
K120360 · HRS
Ortho Solutions Limited
Orthopedic · 113d
Cleared May 29, 2012
UNIMED TEMPERATURE PROBE
K121427 · FLL
Unimed Medical Supplies, Inc.
General Hospital · 15d
Cleared May 25, 2012
HL 568 SELF MONITORING BLOOD GLUCOSE SYSTEM, HL 568BA SELF-MONIROTING BLOOD...
K110074 · NBW
Health & Life Co., Ltd.
Chemistry · 501d
Cleared May 25, 2012
MOBILE VERSA LIGHT
K111049 · FTC
Medtek Lighting Corp
General & Plastic Surgery · 406d
Cleared May 25, 2012
CHOYANG THERMAL MASSAGER
K111941 · JFB
Choyang Medical Instrument Co., Ltd.
Physical Medicine · 322d
Cleared May 25, 2012
CAPILLARYS HEMOGLOBIN, CAPILLARYS FLEX PIERCING SYSTEM
K112550 · GKA
Sebia
Hematology · 267d
Cleared May 25, 2012
SPIRTIUS CUFF INFLATION SYRINGE
K112915 · BSK
Spiritus Technologies, LLC
Anesthesiology · 235d
Cleared May 25, 2012
I-FUSE HAMMER TOE SYSTEMS
K113006 · HWC
Orthopro, LLC
Orthopedic · 231d
Cleared May 25, 2012
OPTOS ADVANCE
K113696 · NFJ
Optos Plc.
Ophthalmic · 161d
Cleared May 25, 2012
VPAP TX
K113714 · MNS
Resmed, Ltd.
Anesthesiology · 158d
Cleared May 25, 2012
VPAP ADAPT
K113801 · BZD
ResMed Corp
Anesthesiology · 155d
Cleared May 25, 2012
SHASER HRS2 HAIR REMOVAL SYSTEM
K120080 · ONF
Shaser, Inc.
General & Plastic Surgery · 135d
Cleared May 25, 2012
SYNTHES ACIS/VERTEBRAL SPACER CR
K120275 · ODP
Synthes (Usa), LLC
Orthopedic · 116d
Cleared May 25, 2012
PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUIUS RENAL REPLACEMENT THERAPY
K120333 · KPO
Gambro Renal Products
Gastroenterology & Urology · 112d
Cleared May 25, 2012
AMT T-FASTENER ANCHOR KIT
K120587 · KGC
Applied Medical Technology, Inc.
Gastroenterology & Urology · 88d
Cleared May 25, 2012
K-LASER
K120604 · ILY
Eltech S.R.L
General & Plastic Surgery · 87d
Cleared May 25, 2012
MEDTRONIC CLEAR INTRAVACULAR ARTERIOTOMY SHUNT
K120612 · DWF
Medtronic, Inc.
Cardiovascular · 86d
Cleared May 25, 2012
PATIENT MONITOR
K120631 · MHX
Advanced Instruments, Inc.
Cardiovascular · 85d
Cleared May 25, 2012
RANGE SPINAL SYSTEM, UNIT ROD
K120899 · MNI
K2m, Inc.
Orthopedic · 60d
Cleared May 25, 2012
UPSTREAM GR CATHETER
K120964 · DQY
Upstream Peripheral Technologies
Cardiovascular · 56d
Cleared May 25, 2012
COPAN MSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM
K121039 · JTW
Copan Flock Technologies
Microbiology · 50d