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
41785–41808 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 14, 2013
SMARTGUARD NIGHT GUARD, SMARTGUARD ORIGINAL, SMARTGUARD NIGHT GUARD ORIGINAL,...
K123161 · MQC
Smartguard, Inc.
Dental · 156d
Cleared Mar 14, 2013
RESOLUTIONMD MOBILE 3.1 MODEL RMD-MOB-31
K123186 · LLZ
Calgary Scientific, Inc.
Radiology · 154d
Cleared Mar 14, 2013
EASYCARE ONLINE
K123557 · MNS
Resmed, Ltd.
Anesthesiology · 115d
Cleared Mar 14, 2013
PARAGON HIP SYSTEM
K123782 · LZO
Global Manufacturing Technology
Orthopedic · 94d
Cleared Mar 14, 2013
ELLIPSE OCCIPITO-CERICO-THORACIC SPINAL SYSTEM AND CAPITOL IMPLANTS
K123783 · KWP
Globus Medical, Inc.
Orthopedic · 94d
Cleared Mar 14, 2013
BEGOPAL+
K123929 · EJH
Bego Bremer Goldschlaegerei Wilh....
Dental · 84d
Cleared Mar 14, 2013
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - CEFTAROLINE
K123933 · LTT
Siemens Healthcare Diagnostics, Inc.
Microbiology · 84d
Cleared Mar 14, 2013
CHINA NAILS AND ACCESSORIES
K123948 · JDS
Smith & Nephew, Inc.
Orthopedic · 83d
Cleared Mar 14, 2013
CATALYST II AND III
K130124 · DXC
Cardiva Medical, Inc.
Cardiovascular · 56d
Cleared Mar 14, 2013
NANOTACK SUTURE ANCHOR 1.4MM WITH FLEX INSERTER
K130351 · MBI
Pivot Medical, Inc.
Orthopedic · 30d
Cleared Mar 14, 2013
VERSAPORT V2 BLADELESS OPTICAL TROCAR
K130435 · GCJ
Covidien, Formerly US Surgical A...
General & Plastic Surgery · 21d
Cleared Mar 13, 2013
BIOGENESIS IMPLANT SYSTEM
K120089 · DZE
Biogenesis Co., Ltd.
Dental · 427d
Cleared Mar 13, 2013
AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN...
K121156 · DHB
Phadia AB
Immunology · 331d
Cleared Mar 13, 2013
VISIOFOCUS
K122412 · FLL
Tecnimed S.R.L.
General Hospital · 217d
Cleared Mar 13, 2013
NOBELPROCERA TI ABUTMENT CAMLOG PLATFORMS
K122602 · NHA
Nobel Biocare AB
Dental · 198d
Cleared Mar 13, 2013
ORALID
K123169 · NXV
Forward Science, LLC
Dental · 155d
Cleared Mar 13, 2013
EZ GLIDE AORTIC CANNULA, AORTIC PERFUSION CANNULA WITH DURAFLO COATING,...
K123370 · DWF
Edwards Lifesciences, LLC
Cardiovascular · 132d
Cleared Mar 13, 2013
INSIGNIA WITH ITERO
K123416 · DYW
Ormco Corp.
Dental · 127d
Cleared Mar 13, 2013
OPTIMA MR450W
K123522 · LNH
Ge Healthcare (Ge Medical Systems, LLC)
Radiology · 118d
Cleared Mar 13, 2013
K SERIES CPAP SYSTEMS
K123897 · BZD
Curative Medical, Inc.
Anesthesiology · 85d
Cleared Mar 13, 2013
NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS)
K124053 · FRN
Carticept Medical, Inc.
General Hospital · 72d
Cleared Mar 13, 2013
PULMOSAL
K130091 · CAF
Pharmacaribe
Anesthesiology · 57d
Cleared Mar 13, 2013
NUVON VITALS CHARTING SYSTEM
K130234 · MWI
Nuvon, Inc.
Cardiovascular · 42d
Cleared Mar 13, 2013
ESOPHAGUS BOUGIE SET
K130251 · JAQ
Varian Medical Systems, Inc.
Radiology · 40d