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
78553–78576 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 28, 2001
DIAMEDIX IS-ANTI-GLIADIN IGG TEST SYSTEM
K012795 · MST
Diamedix Corp.
Immunology · 38d
Cleared Sep 28, 2001
DIAMEDIX IS-ANTI-GLIADIN IGA TEST SYSTEM
K012797 · MST
Diamedix Corp.
Immunology · 38d
Cleared Sep 28, 2001
LIQUISPX LIQUID SALIVA OR UNRINE DRUG OF ABUSE CONTROL
K012907 · DIF
Clinical Controls
Chemistry · 30d
Cleared Sep 28, 2001
3I LOCATER ABUTMENT SYSTEM
K012911 · DZE
Implant Innovations, Inc.
Dental · 29d
Cleared Sep 28, 2001
BARD UTAVERSE SMALL VESSEL PTA BALLOON DILATATION CATHETER
K012913 · DQY
C.R. Bard, Inc.
Cardiovascular · 29d
Cleared Sep 28, 2001
MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000
K012926 · MTD
Endocardial Solutions, Inc.
Cardiovascular · 28d
Cleared Sep 28, 2001
CELL-DYN 3200 SYSTEM WITH ABSOLUTE AND PERCENT RETICULOCYTE
K012934 · GKZ
Abbott Laboratories
Hematology · 28d
Cleared Sep 28, 2001
AEROVENT II CHC COLLAPSIBLE HOLDING CHAMBER
K012939 · CAF
Monaghan Medical Corp.
Anesthesiology · 28d
Cleared Sep 28, 2001
REAADS ANTI-BETA 2 GLYCOPROTEIN I IGM TEST KIT
K013077 · MSV
Corgenix, Inc.
Immunology · 14d
Cleared Sep 28, 2001
REAADS ANTI-BETA 2 GLYCOPROTEIN I IGA TEST KIT
K013079 · MSV
Corgenix, Inc.
Immunology · 14d
Cleared Sep 28, 2001
REAADS ANTI-BETA 2 GLYCOPROTEIN I IGG TEST KIT
K013080 · MSV
Corgenix, Inc.
Immunology · 14d
Cleared Sep 28, 2001
ADC COMPACT PLUS
K013138 · MQB
Agfa-Gevaert AG
Radiology · 9d
Cleared Sep 28, 2001
TE ME NA POLYSTIM NERVE STIMILATOR
K990323 · BXN
Te ME NA S.A.R.L.
Anesthesiology · 969d
Cleared Sep 27, 2001
SLENDERTONE FLEX, MODEL, 512
K010335 · NGX
Bio-Medical Research, Ltd.
Physical Medicine · 237d
Cleared Sep 27, 2001
DIDECO D901 LILLIPUT HOLLOW FIBER OXYGENATOR WITH OR WITHOUT SOFT VENOUS...
K010478 · DTZ
Dideco
Cardiovascular · 219d
Cleared Sep 27, 2001
DIALYSATE LINE WITH CONNECTORS/RE-USE WASH-OUT LINES
K010712 · FID
Molded Products, Inc.
Gastroenterology & Urology · 202d
Cleared Sep 27, 2001
VITALLINK 1200 MOBILE VITAL SIGNS SYSTEMS (VL 1200 SYSTEM)
K010732 · MWI
Telemedic Systems, Inc.
Cardiovascular · 199d
Cleared Sep 27, 2001
EXEL INJECTION PLUG WITH CAP
K011405 · FPA
Exelint Intl. Co.
General Hospital · 142d
Cleared Sep 27, 2001
VANGUARD REPROCESSED ELECTRIC BIOPSY FORCEPS
K011800 · NLU
Vanguard Medical Concepts, Inc.
Gastroenterology & Urology · 111d
Cleared Sep 27, 2001
PF2
K012062 · KTT
Fixano SA
Orthopedic · 87d
Cleared Sep 27, 2001
RADIOFIX
K012078 · KTT
Fixano SA
Orthopedic · 87d
Cleared Sep 27, 2001
COMPCORE AF COMPOSITE CORE BUILD-UP MATERIAL, MODEL 3001408
K012160 · EBF
Premier Dental Products Co.
Dental · 78d
Cleared Sep 27, 2001
NUMARIS 4VA15A
K012202 · LNH
Siemens Medical Corp.
Radiology · 76d
Cleared Sep 27, 2001
COLOR-MONOGEN
K012901 · KTN
Instrumentation Laboratory CO
Immunology · 29d