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
76225–76248 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 21, 2002
CLIP PISTON AWENGEN, MODEL# 1006 805 - 1006 861
K021479 · ETB
Heinz Kurz GmbH Medizintechnik
Ear, Nose, Throat · 13d
Cleared May 21, 2002
LORENZ 1.5 X 4 MM LACTOSORB TAP FREE SCREW
K021522 · DZL
Walter Lorenz Surgical, Inc.
Dental · 11d
Cleared May 21, 2002
SIMPLICITY EASY P SOFT INFUSION SET FOR INFUSION AND/OR INJECTION OF FLUIDS...
K021530 · FPA
Sterling Medivations, Inc.
General Hospital · 11d
Cleared May 20, 2002
GALILEO CAS/NAV TKR SYSTEM
K020298 · HAW
Plus Orthopedics
Neurology · 112d
Cleared May 20, 2002
AGILITY ANKLE REVISION PROSTHESIS
K020541 · HSN
Depuy, Inc.
Orthopedic · 90d
Cleared May 20, 2002
TISSUELINK BIPOLAR FLOATING BALL DEVICE
K020574 · GEI
Tissuelink Medical, Inc.
General & Plastic Surgery · 88d
Cleared May 20, 2002
SYNTHES PILON PLATE
K020602 · HRS
Synthes
Orthopedic · 87d
Cleared May 20, 2002
TRANSTAR INTRACRANIAL PRESSURE TRANSDUCER, MODEL MX950ICP
K020780 · GWM
Medex, Inc.
Neurology · 70d
Cleared May 20, 2002
APEX 800 LASER SYSTEM, MODEL APEX 800
K020849 · GEX
Iridex Corp
General & Plastic Surgery · 66d
Cleared May 20, 2002
BONE MARROW ASPIRATION NEEDLE, MODEL BMB1110J, BONE MARROW HARVEST NEEDLE,...
K020867 · KNW
Worldwide Medical Technologies, LLC
Gastroenterology & Urology · 63d
Cleared May 20, 2002
SERRALESTER
K020902 · GAT
Serral, S.A. DE C.V.
General & Plastic Surgery · 61d
Cleared May 20, 2002
MODIFICATION TO HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YYY-ZZZZ
K021025 · MQP
Implex Corp.
Orthopedic · 52d
Cleared May 20, 2002
ISOSEEDS I-125
K021343 · KXK
Bebig Isotopen-Und Medizintechnik GmbH
Radiology · 21d
Cleared May 17, 2002
INFANT PLETHYSMOGRAPH, MODEL 004400
K011344 · BZC
Collins Medical, Inc.
Anesthesiology · 380d
Cleared May 17, 2002
CARBON POST
K012496 · ELR
J. Morita USA, Inc.
Dental · 287d
Cleared May 17, 2002
VECTOR F SERIES HIGH-SPEED DENTAL HANDPIECES
K020113 · EBF
Vector Research & Development
Dental · 126d
Cleared May 17, 2002
AMSCO CENTURY MEDIUM STERILIZER 26 X 26
K020747 · FLE
STERIS Corporation
General Hospital · 71d
Cleared May 17, 2002
QUICKVUE ONE-STEP HCG-URINE
K020799 · JHI
Quidel Corp.
Chemistry · 66d
Cleared May 17, 2002
QUICKVUE ONE-STEP HCG-COMBO
K020801 · JHI
Quidel Corp.
Chemistry · 66d
Cleared May 17, 2002
MICROSCAN MICROSTREP PLUS PANEL-TETRACYCLINE
K020939 · LTT
Dade Microscan, Inc.
Microbiology · 56d
Cleared May 17, 2002
HOLY DRAGON BRAND ACUPUNCTURE NEEDLES
K021095 · MQX
Wujiang City Hua Xin Medical...
General Hospital · 43d
Cleared May 17, 2002
24CM POURCHEZ XPRESSO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED...
K021212 · MSD
Spire Biomedical, Inc.
Gastroenterology & Urology · 30d
Cleared May 17, 2002
SMARTWIRE/SMARTMAP PRESSURE SYSTEM
K021219 · DQX
Jomed, Inc.
Cardiovascular · 30d
Cleared May 17, 2002
Z3 GUIDE CATHETER
K021256 · DQY
Medtronic Vascular
Cardiovascular · 28d