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
75889–75912 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 25, 2002
MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER
K020985 · KNT
Tfx Medical, Inc.
Gastroenterology & Urology · 90d
Cleared Jun 25, 2002
BMN I TYPE MARROW ASPIRATION NEEDLE
K020987 · KNW
H.S. Hospital Service S.R.L.
Gastroenterology & Urology · 90d
Cleared Jun 25, 2002
LAMINARIA 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM
K021012 · HDY
Quality Medical Solusions, LLC
Obstetrics & Gynecology · 88d
Cleared Jun 25, 2002
TITANIUM CANNULATED INTERFERENCE SCREW
K021030 · HWC
Future Medical Systems, Inc.
Orthopedic · 88d
Cleared Jun 25, 2002
SYSMEX XT-SERIES, MODEL XT-2000I AND XT-1800I
K021241 · GKZ
Sysmex Corporation of America
Hematology · 67d
Cleared Jun 25, 2002
MODIFICATION TO PARA 5X
K021922 · JPK
Streck Laboratories, Inc.
Hematology · 14d
Cleared Jun 25, 2002
MEDICA EASYQC BLOOD GAS/ELECTROLYTE CONTROL
K021930 · JJY
Bionostics, Inc.
Chemistry · 13d
Cleared Jun 24, 2002
REPROCESSED EXTERNAL FIXATION DEVICE
K012623 · KTT
Alliance Medical Corp.
Orthopedic · 315d
Cleared Jun 24, 2002
REPROCESSED EXTERNAL FIXATION DEVICE
K012634 · KTW
Alliance Medical, Inc.
Orthopedic · 315d
Cleared Jun 24, 2002
REPROCESSED EBI EXTERNAL FIXATION DEVICES
K012645 · KTW
Alliance Medical Corp.
Orthopedic · 315d
Cleared Jun 24, 2002
REPROCESSED HOWMEDICA EXTERNAL FIXATION DEVICES
K012648 · KTT
Alliance Medical Corp.
Orthopedic · 315d
Cleared Jun 24, 2002
GLUCOPRO EVO INFUSION PUMP
K013309 · LZG
Nipro Diabetes Systems, Inc.
General Hospital · 263d
Cleared Jun 24, 2002
CARDEON AEGIS CATHETER
K013593 · DWF
Cardeon Corp.
Cardiovascular · 237d
Cleared Jun 24, 2002
TANITA BODY COMPOSITION ANALYZER
K014009 · MNW
Tanita Corp. of America
Gastroenterology & Urology · 201d
Cleared Jun 24, 2002
CHOLESTEROL 1, 2, 3
K014018 · LBS
Imi
Chemistry · 200d
Cleared Jun 24, 2002
CASTLE PERACETIC ACID BIOLOGICAL INDICATOR KIT
K020205 · FRC
Getinge/Castle, Inc.
General Hospital · 153d
Cleared Jun 24, 2002
DUPLOJECT EASY-PREP SYSTEM 1ML, 2ML, 5ML
K020666 · FMF
Baxter Healthcare Corp
General Hospital · 115d
Cleared Jun 24, 2002
MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE IN VARIOUS FILL SIZES - 1 ML FILL IN 6...
K020996 · NGT
Medefil, Inc.
General Hospital · 88d
Cleared Jun 24, 2002
SUBDURAL STRIP ELECTRODE
K021144 · GYC
Nicolet Biomedical, Inc.
Neurology · 76d
Cleared Jun 24, 2002
M2376 DEVICELINK SYSTEM
K021912 · MWI
Philips Medical Systems, Inc.
Cardiovascular · 13d
Cleared Jun 24, 2002
MEDICA EASYQC HEMATOCRIT CONTROL
K021924 · GLK
Bionostics, Inc.
Hematology · 13d
Cleared Jun 21, 2002
ABSORBENT ANTIMICROBIAL WOUND DRESSING
K013814 · FRO
Convatec, A Division of E.R. Squibb &...
General & Plastic Surgery · 217d
Cleared Jun 21, 2002
QUPID PLUS E.R.
K020378 · JHI
Stanbio Laboratory
Chemistry · 136d
Cleared Jun 21, 2002
CANDELA CBEAM PULSED DYE LASER SYSTEM
K020958 · GEX
Candela Corp.
General & Plastic Surgery · 88d