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
56113–56136 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 18, 2008
PROGENIX PLUS
K081950 · NUN
Medtronic Sofamor Danek, Inc.
Dental · 9d
Cleared Jul 17, 2008
PRECISION FLOW
K072845 · BTT
Vapotherm, Inc.
Anesthesiology · 287d
Cleared Jul 17, 2008
ESENSOR WARFARIN SENSITIVITY AND XT-8 INSTRUMENT
K073720 · ODW
Osmetech Molecular Diagnostics
Toxicology · 199d
Cleared Jul 17, 2008
APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 AND 993-25201
K080123 · CFR
Wako Chemicals USA, Inc.
Chemistry · 182d
Cleared Jul 17, 2008
STRYKER POWER TOOL NAVIGATOR ATTACHMENT
K080450 · HAW
Stryker Corp.
Neurology · 149d
Cleared Jul 17, 2008
PHARAON 980 ENDO/EXO, OSYFIBRE 600, CONTROL4+ HANDPIECE
K080731 · GEX
Osyris
General & Plastic Surgery · 125d
Cleared Jul 17, 2008
HG II FIXTURE SYSTEM
K080744 · DZE
Osstem Implant Co., Ltd.
Dental · 122d
Cleared Jul 17, 2008
MTG INSTANT CATHER (WITH AND WITHOUT KIT), MTG INSTANT CATH DELUXE (WITH AND...
K080878 · KOD
Medical Technologies of Georgia, Inc.
Gastroenterology & Urology · 108d
Cleared Jul 17, 2008
AEQUALIS REVERSED SHOULDER PROSTHESIS
K081059 · PHX
Tornier
Orthopedic · 94d
Cleared Jul 17, 2008
VISENSIA
K081140 · MHX
Obs Medical
Cardiovascular · 86d
Cleared Jul 17, 2008
COMPOSITE HITCH SUTURE ANCHOR
K081172 · JDR
Biomet Manufacturing Corp
Orthopedic · 84d
Cleared Jul 17, 2008
PATHWAY PV ATHERECTOMY SYSTEM
K081328 · MCW
Pathway Medical Technologies, Inc.
Cardiovascular · 66d
Cleared Jul 17, 2008
BD SPINAL NEEDLE, MODELS: 405081, 405235, 405236, 405237
K081446 · BSP
Becton, Dickinson & CO
Anesthesiology · 56d
Cleared Jul 17, 2008
SYNTHES (USA) STERNAL FIXATION SYSTEM - LINE EXTENSION
K081700 · HWC
Synthes (Usa)
Orthopedic · 30d
Cleared Jul 17, 2008
AEQUALIS SHOULDER FRACTURE AND SHOULDER SYSTEMS
K081707 · KWS
Tornier, Inc.
Orthopedic · 30d
Cleared Jul 17, 2008
ADVIA CENTAUR HAVM ASSAY
K081716 · LOL
Siemens Healthcare Diagnostics, Inc.
Microbiology · 29d
Cleared Jul 16, 2008
PRE-VA VAGINAL LUBRICANT
K072741 · PEB
Ingfertility, LLC
Obstetrics & Gynecology · 293d
Cleared Jul 16, 2008
DIAZYME APOLIPOPROTEIN A-1 ASSAY
K072977 · MSJ
General Atomics
Chemistry · 268d
Cleared Jul 16, 2008
LION SE ONE STEP ORTHODONTIC ADHESIVE
K080445 · DYH
Classone Orthodontics, Inc.
Dental · 148d
Cleared Jul 16, 2008
QUANTUM/ CANON CXDI INTEGRATION SYSTEM, MODEL QG-DIG-CXDI
K080905 · LLZ
Quantum Medical Imaging, LLC
Radiology · 106d
Cleared Jul 16, 2008
ENDOBUTTON CONTINUOUS LOOP (CL)
K081098 · JDR
Smith & Nephew Inc., Endoscopy Division
Orthopedic · 90d
Cleared Jul 16, 2008
AMPLIVOX OTOWAVE 102 HAND HELD PORTABLE TYMPANOMETER
K081841 · ETY
Amplivox, Ltd.
Ear, Nose, Throat · 16d
Cleared Jul 16, 2008
EMP-2100 FULL DIGITAL ULTRASOUND DIAGNOSTIC DEVICE
K081873 · IYO
Shenzhen Emperor Electronic...
Radiology · 14d
Cleared Jul 15, 2008
ULTRASONIC NEBULISER MODEL 2010
K072136 · CAF
Wilfred Kromker GmbH
Anesthesiology · 348d