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
53785–53808 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 16, 2009
SILVER WOUND PAD
K083659 · FRO
Milliken & Co.
General & Plastic Surgery · 127d
Cleared Apr 16, 2009
TOPIRAMATE ASSAY, ARK TOPIRAMATE CALIBRATOR AND ARK TOPIRAMATE CONTROL,...
K083799 · NWM
ARK Diagnostics, Inc.
Toxicology · 115d
Cleared Apr 16, 2009
ACTHERM INFRARED EAR THERMOMETER, ACT 8000 SERIES
K090031 · FLL
Actherm, Inc.
General Hospital · 101d
Cleared Apr 16, 2009
PROGASTRO CD ASSAY
K090239 · LLH
Prodesse, Inc.
Microbiology · 73d
Cleared Apr 16, 2009
VALIDATE CM2 CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 402
K090475 · JJY
Maine Standards Co.
Chemistry · 51d
Cleared Apr 16, 2009
PAJUNK DISPOSABLE BALLOONS AND BALLOON SYSTEMS
K090631 · GCJ
PAJUNK GmbH Medizintechnologie
General & Plastic Surgery · 38d
Cleared Apr 16, 2009
MODIFICATION TO: GIRAFFE AND PANDA WARMER
K090697 · FMT
Ohmeda Medical
General Hospital · 30d
Cleared Apr 16, 2009
HYPERGLIDE OCCLUSION BALLOON SYSTEM
K090728 · MJN
Ev3, Inc.
Cardiovascular · 28d
Cleared Apr 16, 2009
ABT GLUCOSE CONTROL SOLUTION, MODEL 2120090
K090854 · JJX
American Biological Technologies, Inc.
Chemistry · 17d
Cleared Apr 15, 2009
ORTHO T. CRUZI ELISA TEST SYSTEM
K072732 · MIU
Ortho-Clinical Diagnostics, Inc.
Microbiology · 567d
Cleared Apr 15, 2009
TRI T-STAT REAGENT ASSAY (DRIED FORM) MODEL 25107-00
K082091 · GKZ
Reametrix, Inc.
Hematology · 265d
Cleared Apr 15, 2009
TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER
K082997 · FOZ
Terumo Medical Corp.
General Hospital · 189d
Cleared Apr 15, 2009
IBA PROTON THERAPY SYSTEM - PROTEUS 235
K083058 · LHN
Ion Beam Applications S.A.
Radiology · 183d
Cleared Apr 15, 2009
EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG)
K083381 · LRM
Euroimmun Us, Inc.
Immunology · 152d
Cleared Apr 15, 2009
CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIX ANNULOPLASTY RING, MODEL 4100
K083623 · KRH
Edwards Lifesciences, LLC
Cardiovascular · 128d
Cleared Apr 15, 2009
ENDOSKELETON TT INTERBODY FUSION DEVICE (IBD)
K083714 · MAX
Titan Spine, LLC
Orthopedic · 121d
Cleared Apr 15, 2009
BCI WW1000 PULSE OXIMETER, MODEL WW1000
K083787 · DQA
Smiths Medical Pm, Inc.
Anesthesiology · 117d
Cleared Apr 15, 2009
ATLANTIS STRAUMANN BONE LEVEL ABUTMENT, ATLANTIS GEMINI STRAUMANN BONE LEVEL...
K083871 · NHA
Astra Tech, Inc.
Dental · 107d
Cleared Apr 15, 2009
NAVI ROOT
K083901 · LQY
S-Denti Co., Ltd.
Dental · 107d
Cleared Apr 15, 2009
VIDISTAR PACS & DICOM VIEWER SOFTWARE SERVER SOFTWARE SYSTEM, HEART VIEW,...
K083910 · LLZ
Vidistar, LLC
Radiology · 106d
Cleared Apr 15, 2009
PRE-FILLED CATHETER INFLATION SYRINGE
K090121 · KNY
Avail Medical Products, Inc.
Gastroenterology & Urology · 84d
Cleared Apr 15, 2009
MD213MG 21.3 DIAGNOSTIC IMAGING LCD MONITOR - L218TL
K090215 · LLZ
Nec Display Solutions , Ltd.
Radiology · 76d
Cleared Apr 15, 2009
MD213MC 21.3 DIAGNOSTIC IMAGING LCD MONITOR MODEL, L218TJ
K090218 · LLZ
Nec Display Solutions , Ltd.
Radiology · 76d
Cleared Apr 15, 2009
ENSPIRE DEBRIDER SYSTEM
K090278 · HRX
Spine View, Inc.
Orthopedic · 70d