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

Filters: Cleared only ×
176,076 results
66601–66624 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 28, 2005
MUELLER WATER CONDITIONING WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
K041884 · FIP
Mueller Water Conditioning, Inc.
Gastroenterology & Urology · 231d
Cleared Feb 28, 2005
ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA)
K042272 · KTN
ACON Laboratories, Inc.
Immunology · 189d
Cleared Feb 28, 2005
TRIAGE TOX DRUG SCREEN
K043242 · LDP
Biosite Incorporated
Toxicology · 97d
Cleared Feb 28, 2005
SHEATHES NEEDLE GUIDE, MODEL NG-SR-A-484-KIT (THERE WILL BE VARIOUS MODEL...
K043425 · ITX
Sheathing Technologies, Inc.
Radiology · 77d
Cleared Feb 28, 2005
MODIFICATION TO ENDOVASCULAR GUIDE WIRE
K043457 · DQX
Stereotaxis, Inc.
Cardiovascular · 75d
Cleared Feb 28, 2005
CUSTODIOL
K043461 · KDL
Dr. Franz Kohler Chemie GmbH
Gastroenterology & Urology · 75d
Cleared Feb 28, 2005
VITEK 2 GRAM POSITIVE DAPTOMYCIN
K050075 · LON
bioMerieux, Inc.
Microbiology · 47d
Cleared Feb 28, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AMPICILLIN-SULBACTAM (GP) 2-32 UG/ML
K050089 · LON
Becton, Dickinson & CO
Microbiology · 45d
Cleared Feb 28, 2005
MAGNETOM TRIO A TIM SYSTEM
K050200 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 31d
Cleared Feb 28, 2005
USGI SHAPELOCK ENDOSCOPIC GUIDE
K050253 · FED
Usgi Medical
Gastroenterology & Urology · 25d
Cleared Feb 28, 2005
IPACS PRISM-5.0
K050298 · LLZ
Realtimeimage, Inc.
Radiology · 21d
Cleared Feb 28, 2005
AIRIS ELITE RAPID BODY COIL
K050307 · MOS
Hitachi Medical Systems America, Inc.
Radiology · 20d
Cleared Feb 28, 2005
7350 ULTRASOUND IMAGING SYSTEM, MODEL 7350
K050326 · IYN
Esaote, S.P.A.
Radiology · 19d
Cleared Feb 25, 2005
CONTACT HEAT-EVOKED POTENTIAL STIMULATOR (CHEPS)
K041908 · NTU
Medoc Ltd. Advanced Medical Systems
Neurology · 225d
Cleared Feb 25, 2005
BEAMCATH
K042110 · EZL
Beampoint AB
Gastroenterology & Urology · 204d
Cleared Feb 25, 2005
BIOBEAM NARROW BAND LIGHT THERAPY DEVICES
K042813 · ILY
Life Without Pain, LLC
Physical Medicine · 136d
Cleared Feb 25, 2005
HOLTER RECORDER H3+
K043010 · MWJ
Mortara Instrument, Inc.
Cardiovascular · 116d
Cleared Feb 25, 2005
BOSWORTH BOND
K043170 · KLE
Harry J. Bosworth Co.
Dental · 101d
Cleared Feb 25, 2005
ENDOASSIST
K043284 · GCJ
Armstrong Healthcare Limited
General & Plastic Surgery · 91d
Cleared Feb 25, 2005
ACON OXY II ONE STEP OXYCODONE TEST STRIP
K043507 · DJG
ACON Laboratories, Inc.
Toxicology · 67d
Cleared Feb 25, 2005
MOMENTS MENOPAUSE CHECK, MODEL 9113
K043599 · CGJ
Phamatech, Inc.
Chemistry · 58d
Cleared Feb 25, 2005
PHILIPS HEARTSTART FRX DEFIBRILLATOR, MODEL 861304
K050004 · MKJ
Philips Medical Systems
Cardiovascular · 54d
Cleared Feb 25, 2005
SYNTHES (USA) STERILE STERNAL FIXATION SYSTEM
K050041 · JDQ
Synthes (Usa)
Orthopedic · 49d
Cleared Feb 25, 2005
RNA1C HEMOGLOBIN A1C CONTROL FOR BAYER DCA2000 AND DCA2000+ ANALYZER
K050100 · JJX
Bionostics, Inc.
Chemistry · 38d