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
63505–63528 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 27, 2006
DERMASTREAM
K060046 · NAD
Enzysurge , Ltd.
General & Plastic Surgery · 52d
Cleared Feb 27, 2006
DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT CARTRIDGE
K060090 · JLW
Dade Behring, Inc.
Chemistry · 46d
Cleared Feb 27, 2006
GROSSMAN SELF-RETAINING LOW PROFILE BRAIN RETRACTOR, MODEL 04-001-00
K060097 · GZT
KLS-Martin L.P.
Neurology · 45d
Cleared Feb 27, 2006
UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM
K060256 · CFR
Beckman Coulter, Inc.
Chemistry · 26d
Cleared Feb 27, 2006
SHOULDER FIXATION SYSTEM
K060290 · LXT
Hand Innovations, LLC
Orthopedic · 21d
Cleared Feb 27, 2006
PREFORMANCE TEMPORARY CYLINDER
K060291 · NHA
Implant Innovations, Inc.
Dental · 21d
Cleared Feb 27, 2006
MODIFICATION TO: TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT
K060348 · CEW
Scantibodies Laboratory, Inc.
Chemistry · 17d
Cleared Feb 24, 2006
ES-160
K051020 · GZJ
Lhasa Oms, Inc.
Neurology · 308d
Cleared Feb 24, 2006
GERATHERM SOS-RESCUE BLANKET
K051097 · DWJ
Rg Ent., Inc.
Cardiovascular · 301d
Cleared Feb 24, 2006
TECHDEVICE OCCLUSION BALLOON CATHETER
K051137 · MJN
Techdevice Corporation
Cardiovascular · 296d
Cleared Feb 24, 2006
DISC-FX SYSTEM
K052241 · HRX
Ellman International, Inc.
Orthopedic · 191d
Cleared Feb 24, 2006
ABRACAIR AIR CLEANER, MODEL QTZ300-60
K052732 · FRA
Abracair, Inc.
General Hospital · 148d
Cleared Feb 24, 2006
TRITON/TRU-TRAC/TX/TRITON DTS TRACTION
K053223 · ITH
Chattanooga Group
Physical Medicine · 99d
Cleared Feb 24, 2006
CPS DIRECT SL OUTER CATHETER
K053277 · DQY
St Jude Medical
Cardiovascular · 93d
Cleared Feb 24, 2006
MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN...
K053504 · LON
Dade Behring, Inc.
Microbiology · 70d
Cleared Feb 24, 2006
REPROCESSED COMPRESSION SLEEVES
K060049 · JOW
Alliance Medical Corp.
Cardiovascular · 49d
Cleared Feb 24, 2006
PEDIATRIC URINARY CATHETER
K060268 · GBM
Clay Kennard
Gastroenterology & Urology · 23d
Cleared Feb 24, 2006
FILE-EZE
K060335 · KJJ
Ultradent Products, Inc.
Dental · 15d
Cleared Feb 24, 2006
CONSTRUX PL/TL PEEK PARTIAL VBR SYSTEM
K060350 · MQP
Blackstone Medical, Inc.
Orthopedic · 14d
Cleared Feb 24, 2006
CRYO, MODEL V6.0
K060395 · GEX
Zimmer Elektromedizin GmbH
General & Plastic Surgery · 9d
Cleared Feb 23, 2006
FLEX-AID LIQUID GEL BANDAGE AND DERMAFLEX GEL TISSUE ADHESIVE PROFESSIONAL...
K050757 · KMF
Chemence Medical, Inc.
General & Plastic Surgery · 337d
Cleared Feb 23, 2006
POCKET BREATHALYZER. CONNECTABLES
K052448 · DJZ
Connectables, LLC
Toxicology · 169d
Cleared Feb 23, 2006
FERRITIN LIT ASSAY, CATALOG NO. 7010
K052617 · DBF
Good Biotech Corp.
Immunology · 153d
Cleared Feb 23, 2006
BIORAPTOR SUTURE ANCHOR, TWINFIX 2.8 MM SUTURE ANCHOR, TWINFIX 3.5 MM SUTURE...
K053344 · HWC
Smith & Nephew, Inc.
Orthopedic · 83d