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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
48241–48264 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 11, 2011
COMPLEX HELICAL 18, MULTI-LOOP 18, FIGURE 8-18, STRAIGHT 18 FIBERED PLATINUM...
K102714 · KRD
Boston Scientific Corp
Cardiovascular · 144d
Cleared Feb 11, 2011
O2-IN-A-BOX, O2-IN-A-BOX
K102750 · CAW
Geto2, Inc.
Anesthesiology · 141d
Cleared Feb 11, 2011
SMART READ BIOLOGICAL TEST PACK
K103000 · JOJ
Steritec Products Mfg Co, Inc.
General Hospital · 126d
Cleared Feb 11, 2011
ELECSYS ANTI-TPO CALSET
K103171 · JIX
Roche Diagnostics
Immunology · 107d
Cleared Feb 11, 2011
1.5T OPTIMA MR430S
K103238 · LNH
Ge Medical Systems, LLC
Radiology · 101d
Cleared Feb 11, 2011
BRIVO MR355, OPTIMA MR360
K103330 · LNH
Ge Hangwei Medical Systems Co., Ltd.
Radiology · 91d
Cleared Feb 11, 2011
BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S)
K103345 · ONZ
Breathe Technologies, Inc.
Anesthesiology · 88d
Cleared Feb 11, 2011
DELIKIT PUTTY, DELIKIT HEAVY BODY, DELIKIT LIGHT BODY
K103346 · ELW
Sherpa Korea
Dental · 88d
Cleared Feb 11, 2011
VERSAFITCUP CC TRIO
K103352 · LZO
Medacta International
Orthopedic · 87d
Cleared Feb 11, 2011
MEDTRONIC VASCULAR - HUB MATERIAL MODIFICATION TO THE 5F AND 8F LAUNCHER(R)...
K103386 · DQY
Medtronic, Inc.
Cardiovascular · 85d
Cleared Feb 11, 2011
VISUALIZE: VASCULAR
K103761 · LLZ
The Medipattern Corporation
Radiology · 50d
Cleared Feb 11, 2011
SUPERDIMENSION MARKER DELIVERY KIT
K110093 · JAK
Superdimension, Inc.
Radiology · 30d
Cleared Feb 11, 2011
EDWARDS LIFESCIENCES LEFT ATRIAL PRESSURE MONITOR CATHETER
K110103 · DQO
Edwards Lifesciences, LLC
Cardiovascular · 29d
Cleared Feb 11, 2011
NC TREK RX CORONARY DILATATION CATHETER
K110134 · LOX
Abbott Vascular-Cardiac Therapies
Cardiovascular · 24d
Cleared Feb 11, 2011
SYSLOC MINI V3
K110157 · FIE
JMS North America Corporation
Gastroenterology & Urology · 23d
Cleared Feb 10, 2011
ESWALLOW DYSPHAGIA THERAPY KIT, PMI DYSPHAGIA THERAPY KIT
K092202 · IPF
Eswallow USA
Physical Medicine · 568d
Cleared Feb 10, 2011
COLONRING
K093661 · FZP
Niti Surgical Solutions, Ltd.
General & Plastic Surgery · 442d
Cleared Feb 10, 2011
SWABFLSUH (3ML, 5ML, 10ML) MODEL 10331, 10351, 10311
K101270 · NGT
Excelsior Medical Corp.
General Hospital · 280d
Cleared Feb 10, 2011
MASTERSCREEN IOS
K101873 · BZG
Carefusion Germany 234 GmbH
Anesthesiology · 219d
Cleared Feb 10, 2011
ZEUS SCIENTIFIC, INC. TREPONEMA PALLIDUM IGG TEST SYSTEM
K102283 · LIP
Zeus Scientific, Inc.
Microbiology · 182d
Cleared Feb 10, 2011
LANX FUSION SYSTEM
K102738 · OVD
Lanx, LLC
Orthopedic · 141d
Cleared Feb 10, 2011
HI-TORQUE BALANCE MIDDLEWEIGHT ELITE
K103101 · DQX
Abbott Vascular-Cardiac Therapies
Cardiovascular · 113d
Cleared Feb 10, 2011
VENUS ANTERIOR CERVICAL PLATE
K103137 · KWQ
Verticor, Ltd.
Orthopedic · 108d
Cleared Feb 10, 2011
REDSENSE-ALARM UNIT AND SENSOR
K103242 · ODX
Redsense Medical AB
Gastroenterology & Urology · 100d