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
58825–58848 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 23, 2007
THERMOGARD XP THERMAL REGULATION SYSTEM
K072234 · NCX
Alsius Corp.
Neurology · 13d
Cleared Aug 22, 2007
AXIOM LUMINOS DRF
K062623 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 351d
Cleared Aug 22, 2007
4DDOME
K070918 · FTL
Cousin Biotech
General & Plastic Surgery · 142d
Cleared Aug 22, 2007
CORAL PEDICLE SCREW SYSTEM
K070962 · NKB
Theken Spine, LLC
Orthopedic · 139d
Cleared Aug 22, 2007
MODIFIED MERCI RETRIEVER, MODEL 90060
K071172 · NRY
Concentric Medical, Inc.
Neurology · 117d
Cleared Aug 22, 2007
DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM
K071350 · MCW
Cardiovascular Systems, Inc.
Cardiovascular · 100d
Cleared Aug 22, 2007
15.5F HEMO-STREAM HEMODIALYSIS CATHETER SET
K071422 · MSD
Rex Medical
Gastroenterology & Urology · 92d
Cleared Aug 22, 2007
MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
K071531 · IYE
Accuray Incorporated
Radiology · 78d
Cleared Aug 22, 2007
EXTENDSURE LYOPHILIZED HBA1C LINEARITY CONTROLS
K071648 · JJX
Canterbury Scientific , Ltd.
Chemistry · 65d
Cleared Aug 22, 2007
POWDERED VINYL PATIENT EXAMINATION GLOVES
K071686 · LYZ
Langfang Huilong Plastic Product Co.,...
General Hospital · 63d
Cleared Aug 22, 2007
ELTA SILVER ANTIMICROBIAL WOUND GEL DRESSING, WOUND AND BURN, HYDROGEL W/DRUG...
K071703 · FRO
Swiss American Products, Inc.
General & Plastic Surgery · 62d
Cleared Aug 22, 2007
VELASHAPE
K071872 · NUV
Syneron Medical, Ltd.
General & Plastic Surgery · 47d
Cleared Aug 22, 2007
REFLEXION SPIRAL VARIABLE RADIUS CATHETER
K072012 · DRF
St Jude Medical
Cardiovascular · 30d
Cleared Aug 21, 2007
SILVERSEAL WOUND PACKING STRIPS WITH X-STATIC
K063190 · QSY
Noble Fiber Technologies, Inc.
General & Plastic Surgery · 305d
Cleared Aug 21, 2007
DISPOSABLE PEDICLE SCREW PROBE, MODEL 3603-00
K063729 · GXZ
Technomed Europe
Neurology · 249d
Cleared Aug 21, 2007
TANDA SKINCARE SYSTEM, PLC-001, TANDA BLUE, 414-001, TANDA RED, 660-001
K070185 · GEX
Pharos Life Corporation
General & Plastic Surgery · 214d
Cleared Aug 21, 2007
OLYMPUS FT4-FREE THYROXINE, OLYMPUS T4- TOTAL THYROXINE, MODEL# OSR210102,...
K070708 · CEC
Olympus Life & Material Science...
Chemistry · 160d
Cleared Aug 21, 2007
CONMED LINVATEC XO BUTTON
K070780 · MBI
Conmed Linvatec
Orthopedic · 153d
Cleared Aug 21, 2007
SEARCH EVOLUTION (LC) TOTAL KNEE SYSTEM (PLASMAPORE)
K070981 · JWH
Aesculap Implant Systems, Inc.
Orthopedic · 137d
Cleared Aug 21, 2007
PSS SYSTEM
K071438 · MNI
Spinal USA
Orthopedic · 90d
Cleared Aug 21, 2007
MODEL 300D HOME OXYGEN LIQUEFIER
K071461 · CAW
Copd Partners, Inc.
Anesthesiology · 88d
Cleared Aug 21, 2007
WIELAND ZENO CAO TEMPORARY PMMA DISC, TOOTH-COLORED
K071548 · EBG
Merz Dental GmbH
Dental · 76d
Cleared Aug 21, 2007
TITANIUM HIP TOOL LOCKING PLATE
K072175 · HRS
Orthopedic Sciences, Inc.
Orthopedic · 15d
Cleared Aug 20, 2007
CONMED LINVATEC 300W XENON LIGHT SOURCE
K070376 · GCT
Conmed Linvatec
Gastroenterology & Urology · 193d