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
75073–75096 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 12, 2002
INION CPS 2.5/2.8 SCREW
K022981 · HWC
Inion , Ltd.
Dental · 3d
Cleared Sep 11, 2002
VIDENT HEXTOP, SYNOCTA IN-CERAM BLANK/COPING MANUFACTURED BY VIDENT
K012473 · DZE
Vident
Dental · 405d
Cleared Sep 11, 2002
MADETT
K021044 · BTR
Wolfe Tory Medical, Inc.
Anesthesiology · 163d
Cleared Sep 11, 2002
BIOSOMNIA
K021485 · OMC
Oxford Biosignals Limited
Neurology · 126d
Cleared Sep 11, 2002
RADIONICS POLE NEEDLES
K021942 · GXI
Radionics, A Division of Tyco...
Neurology · 90d
Cleared Sep 11, 2002
CELL ROBOTICS ULTRA-LIGHT PEEL LASER SYSTEM
K021946 · GEX
Cell Robotics, Inc.
General & Plastic Surgery · 90d
Cleared Sep 11, 2002
JOSTRA VENT CATHETERS, MODELS LV & HKV
K022022 · DWF
Jostra AG
Cardiovascular · 83d
Cleared Sep 11, 2002
SOUNDVASER SYSTEM
K022051 · QPB
Sound Surgical Technologies, LLC
General & Plastic Surgery · 79d
Cleared Sep 11, 2002
CONVOY ADVANCED DELIVERY SHEATH
K022067 · DBY
Boston Scientific
Immunology · 78d
Cleared Sep 11, 2002
VERTIS PNT CONTROL UNIT, MODEL CU 100
K022241 · NHI
Vertis Neuroscience, Inc.
Neurology · 62d
Cleared Sep 11, 2002
ADVIA 120 HEMATOLOGY SYSTEM, CEREBROSPINAL FLUID METHOD
K022331 · GKL
Bayer Diagnostics Corp.
Hematology · 55d
Cleared Sep 11, 2002
AUROPAL SOLDER W-2
K022451 · EJT
Wieland Dental + Technik GmbH & Co. KG
Dental · 47d
Cleared Sep 11, 2002
PORTA OP SOLDER M-1
K022452 · EJT
Wieland Dental + Technik GmbH & Co. KG
Dental · 47d
Cleared Sep 11, 2002
IQ PRODUCTS TRIPLE-COLOR FLOW CYTOMETRY REAGENTS, IQ PRODUCTS...
K022528 · GKZ
Iq Corp.
Hematology · 42d
Cleared Sep 11, 2002
MEDLEY SPO2 MODULE, MODEL 8210 & SPO2 SENSORS & CABLE
K022677 · DQA
Alaris Medical Systems, Inc.
Anesthesiology · 30d
Cleared Sep 11, 2002
PORTABLE THERAPEUTIC OXYGEN CONCENTRATION SYSTEM (PTOCS)
K022684 · CAW
Essex Cryogenics of Missouri, Inc.
Anesthesiology · 30d
Cleared Sep 11, 2002
NESS SYSTEM
K022776 · IPF
Ness-Neuromuscular Electrical...
Physical Medicine · 21d
Cleared Sep 11, 2002
MODIFICATION TO DISETRONIC D-TRONPLUS INSULIN INFUSION PUMP
K022831 · LZG
Disetronic Medical Systems AG
General Hospital · 16d
Cleared Sep 11, 2002
MODIFICATION TO BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET
K022875 · JKA
Becton, Dickinson & CO
Chemistry · 12d
Cleared Sep 11, 2002
MODIFICATION TO INFANT LIFE SUPPORT MODULE-20
K022876 · FPL
International Biomedical, Inc.
General Hospital · 12d
Cleared Sep 10, 2002
WIENER LAB. CA-COLOR ARSENAZO III AA, MODEL 4X50 ML CAT.NR. 1152004, WIENER...
K021334 · CJY
Wiener Laboratories Saic
Chemistry · 137d
Cleared Sep 10, 2002
UCR SPINAL SYSTEM, 5.5MM, 8.0MM SCREWS & INSTRUMENTS
K021623 · MNH
Iame, Inc.
Orthopedic · 117d
Cleared Sep 10, 2002
AXYA MEDICAL, INC, MODEL 100 SONIC SCALPEL ULTRASONIC SURGICAL SYSTEM
K021929 · LFL
Axya Medical, Inc.
General & Plastic Surgery · 90d
Cleared Sep 10, 2002
MEDX LCS LASER SERIES
K021985 · NHN
Medx Electronics, Inc.
Physical Medicine · 84d