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
141961–141984 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 18, 1986
SEAL SYRINGE (3CC,5CC,12CC,20CC,30CC & 50CC)
K864414 · FMF
Seal Syringe Corp.
General Hospital · 41d
Cleared Dec 18, 1986
ANGEL LATEX SURGICAL GLOVES
K864521 · KGO
Kim Intl. Trading Co.
General Hospital · 31d
Cleared Dec 18, 1986
TOWELS
K864528
Elof Hansson, Inc.
General & Plastic Surgery · 31d
Cleared Dec 18, 1986
STERILITE STERILIZATION KIT
K864596
Kimberly-Clark Corp.
General & Plastic Surgery · 27d
Cleared Dec 18, 1986
MOORE'S STRAIGHT & THOMPSON'S CURVED STEM PROSTHE.
K864631
Downs Surgical , Ltd.
Orthopedic · 23d
Cleared Dec 18, 1986
VITALLIUM HEX-DRIVE BONE SCREW SYSTEM
K864633 · HWC
Howmedica Corp.
Orthopedic · 23d
Cleared Dec 18, 1986
EXTENSION SETS
K864692 · FPK
Salt Creek Medical Technologies
General Hospital · 16d
Cleared Dec 18, 1986
CK 6000 SERIES, TOWELS
K864697 · KKX
Currie Medical Specialties, Inc.
General Hospital · 16d
Cleared Dec 17, 1986
ELECTROPHORESIS DATA CENTER (EDC)
K860645 · JQT
Helena Laboratories
Chemistry · 300d
Cleared Dec 17, 1986
ASSERT BIOLOGICAL/CHEMICAL INDICATOR 12 MONTH EXP.
K863122 · FRC
Surgicot, Inc.
General Hospital · 125d
Cleared Dec 17, 1986
HOSPAL BIOSPAL 1800S
K863961 · KDI
Hospal Medical Corp.
Gastroenterology & Urology · 68d
Cleared Dec 17, 1986
MEDSURG CUSTOM SURGICAL SCRUB TRAYS
K864463
Medsurg Industries, Inc.
General & Plastic Surgery · 35d
Cleared Dec 17, 1986
SUNFIT SUNLAMP
K864485 · FTC
Sunfit, Inc.
General & Plastic Surgery · 34d
Cleared Dec 17, 1986
MODEL 668, TRACTION SPLINT, ADULT
K864765 · HST
Ferno-Washington, Inc.
Neurology · 12d
Cleared Dec 17, 1986
POIRIER MANUAL WHEELCHAIR
K864790 · IOR
Roseburg SA
Physical Medicine · 9d
Cleared Dec 16, 1986
JEJUNAL FEEDING TUBE
K861309 · KNT
Microvasive
Gastroenterology & Urology · 252d
Cleared Dec 16, 1986
REPLACEMENT GASTROSTOMY TUBE
K861323 · KNT
Microvasive
Gastroenterology & Urology · 252d
Cleared Dec 16, 1986
ENTHERMO IRRIGATION UNIT
K863615 · ETP
Jedmed Instrument Co.
Ear, Nose, Throat · 91d
Cleared Dec 16, 1986
NAPHTHYL PHOSPHATE, ACID PHOSPHATASE
K863832 · JFH
Pointe Scientific, Inc.,
Chemistry · 77d
Cleared Dec 16, 1986
UBI MAGIWEL(TM) PROLACTIN QUANTATIVE
K864075 · CFT
United Biotech, Inc.
Chemistry · 57d
Cleared Dec 16, 1986
UBI MAGIWEL(TM) TSH QUANTITATIVE
K864079 · JLW
United Biotech, Inc.
Chemistry · 57d
Cleared Dec 16, 1986
OEC DESIGN ORTHOPEDIC CAST HEEL
K864092 · LGF
Military Engineering, Inc.
Orthopedic · 56d
Cleared Dec 16, 1986
OHMEDA 7400 ANESTHESIA VENTILATOR
K864129 · CBK
Ohmeda Medical
Anesthesiology · 56d
Cleared Dec 16, 1986
CIBA CORNING MAGIC(R) LITE TU IMMUNOASSAY
K864132 · KHQ
Ciba Corning Diagnostics Corp.
Chemistry · 56d