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
58609–58632 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 19, 2007
PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIES
K072364 · KRB
Pulsion Medical Systems AG
Cardiovascular · 28d
Cleared Sep 18, 2007
EXPEDIUM SPINE SYSTEM
K070387 · NKB
Depuy Spine, Inc.
Orthopedic · 221d
Cleared Sep 18, 2007
EYETRACKER/IDEAS
K070670 · GWN
S.A. Instrumentation Difra
Neurology · 190d
Cleared Sep 18, 2007
EOS
K071546 · KPR
Biospace Med
Radiology · 104d
Cleared Sep 18, 2007
ENDOSCOPIC PLICATION SYSTEM
K071553 · ODE
Ndo Surgical, Inc.
Gastroenterology & Urology · 104d
Cleared Sep 18, 2007
MODIFCATION TO: SPYGLASS IRRIGATION SYSTEM
K071832 · LJH
Medical Scientific, Inc.
Gastroenterology & Urology · 77d
Cleared Sep 18, 2007
SPORTMESH OR ARTELON TISSUE REINFORCEMENT
K071887 · FTL
Artimplant AB
General & Plastic Surgery · 71d
Cleared Sep 18, 2007
INTERPLATE INTERBODY FUSION DEVICE, MODELS C, CGC, L AND LGC
K071922 · OVD
Rsb Spine, LLC
Orthopedic · 68d
Cleared Sep 18, 2007
VITOSS BIOACTIVE FOAM BONE GRAFT SUBSTITUTE
K072184 · MQV
Orthovita, Inc.
Orthopedic · 43d
Cleared Sep 18, 2007
MIDAS REX CURVED BUR
K072315 · HBE
Medtronic Powered Surgical Solutions
Neurology · 29d
Cleared Sep 18, 2007
MODIFICATION TO:TSRH SPINAL SYSTEM
K072317 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 29d
Cleared Sep 18, 2007
ULTRA FAST-FIX AND ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEMS
K072322 · GAT
Smith & Nephew, Inc.
General & Plastic Surgery · 29d
Cleared Sep 18, 2007
NEWTOM VG COMPUTED TOMOGRAPHY X-RAY SYSTEM
K072357 · MUH
Afp Imaging Corp.
Radiology · 27d
Cleared Sep 18, 2007
MODIFICATION TO HYPERQ SYSTEM
K072389 · MWI
Biological Signal Processing, Ltd.
Cardiovascular · 25d
Cleared Sep 17, 2007
VERIGENE SYSTEM, VERIGENE WARFARIN METABOLISM NUCLEIC ACID TEST
K070804 · ODW
Nanosphere, Inc.
Toxicology · 178d
Cleared Sep 17, 2007
BONEMEDIK, AND BONEMEDIK-S
K070897 · MQV
Meta Biomed Co., Ltd.
Orthopedic · 168d
Cleared Sep 17, 2007
HEMOSIL D-DIMER HS
K070927 · DAP
Instrumentation Laboratory CO
Hematology · 167d
Cleared Sep 17, 2007
STRYKER PEEK AND TITANIUM SOFT EYELET ANCHORS
K071157 · HWC
Stryker Endoscopy
Orthopedic · 145d
Cleared Sep 17, 2007
INQU
K071428 · MQV
Isto Technologies, Inc.
Orthopedic · 117d
Cleared Sep 17, 2007
SLEEVE AND BUTTON SOFT TISSUE DEVICES
K071704 · MBI
Biomet Sports Medicine, Inc.
Orthopedic · 88d
Cleared Sep 17, 2007
MONDEAL HAND CONTOUR SYSTEM
K071797 · HRS
Mondeal Medical Systems GmbH
Orthopedic · 77d
Cleared Sep 17, 2007
MONDEAL DISTAL RADIUS SYSTEM
K071798 · HRS
Mondeal Medical Systems GmbH
Orthopedic · 77d
Cleared Sep 17, 2007
LANX SPINAL FIXATION SYSTEM
K071877 · MNI
Lanx, LLC
Orthopedic · 70d
Cleared Sep 17, 2007
DIAZYME HOMOCYSTEINE 2 REAGENT ENZYMATIC ASSAY KIT, AND CALIBRATORS, MODEL(S)...
K071971 · LPS
Diazyme Laboratories
Chemistry · 62d