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
153457–153480 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 16, 1984
FLEXIBLE ORTHOPEDIC ENDOSCOPE ICA-1000
K841087 · HRX
Machida America, Inc.
Orthopedic · 64d
Cleared May 16, 1984
CLAYMAN-PAREL CAPSULE COUPEUR
K841101 · HNY
Miami Eye Technology, Inc.
Ophthalmic · 64d
Cleared May 16, 1984
OEC/REZAIAN SPINAL FIXATOR
K841189 · KWQ
Orthopedic Equipment Co., Inc.
Orthopedic · 57d
Cleared May 16, 1984
FLATPACK CARRYING CASE
K841316
Bausch & Lomb, Inc.
Ophthalmic · 44d
Cleared May 16, 1984
RICHARDS FIXATOR SYSTEM
K841334 · JEC
Richards Medical Co., Inc.
Orthopedic · 44d
Cleared May 16, 1984
HYPERBARIC OXYGEN GURNEY-
K841368 · HST
Orthopedic Systems, Inc.
Neurology · 43d
Cleared May 16, 1984
ACUFEX SHOULDER HOLDER
K841388 · HST
Acufex Microsurgical, Inc.
Neurology · 43d
Cleared May 16, 1984
POTASSIUM CHLORIDE SOLUTION -2 MOLAR
K841417 · JGS
Reagent Laboratory, Inc.
Chemistry · 41d
Cleared May 16, 1984
SODIUM ELECTRODE RINSE SOLUTION 2
K841418 · JGS
Reagent Laboratory, Inc.
Chemistry · 41d
Cleared May 16, 1984
CORNING LACTATE DEHYDROPHORETIC ASSAY
K841433 · CFE
Corning Medical & Scientific
Chemistry · 40d
Cleared May 16, 1984
COMA TOXICOLOGY CONTROL
K841439 · DIF
American Dade
Toxicology · 40d
Cleared May 16, 1984
TOTAL PROTEIN REAGENT BIURET
K841466 · CEK
Reagents Applications, Inc.
Chemistry · 37d
Cleared May 16, 1984
ULTRA CHEM ENZYMATIC TRIGLYCERIDE
K841471 · CDT
Em Diagnostic Systems, Inc.
Chemistry · 37d
Cleared May 16, 1984
DIRECT BILIRUBIN REAGENT
K841572 · CIG
Hi Chem, Inc.
Chemistry · 29d
Cleared May 16, 1984
INSULIN RADIOIMMUNOASSAY KIT
K841573 · CFP
Sorin Biomedica, Fiat, USA, Inc.
Chemistry · 29d
Cleared May 16, 1984
SUN BEDS
K841614 · FTC
Sunworld Corp.
General & Plastic Surgery · 75d
Cleared May 16, 1984
DUPONT THEOPHYLLINE DIT CALIBRATOR
K841655 · DLJ
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 23d
Cleared May 16, 1984
7200 MICROPROCESSOR VENTILATOR
K841757 · CBK
Puritan Bennett Corp.
Anesthesiology · 19d
Cleared May 16, 1984
STROLLER SPRINT
K841808 · BYJ
Cryogenic Assoc.
Anesthesiology · 15d
Cleared May 14, 1984
SPHYGOMANO METER
K833799 · DXN
Fraser Harlake, Inc.
Cardiovascular · 195d
Cleared May 14, 1984
ORTHO ENZYME IMMUNOASSAY HOME PREG.TEST
K834270 · LCX
Advanced Care Products
Chemistry · 158d
Cleared May 14, 1984
YD STRIP GP U20
K834386 · JIL
Yd Pharmaceutical Corp.
Chemistry · 152d
Cleared May 14, 1984
YD STRIP GPH U21
K834387 · JIL
Yd Pharmaceutical Corp.
Chemistry · 152d
Cleared May 14, 1984
SCRATCH & SNIFF FOR ANESTHESIA
K840431 · CAI
Dryden Corp.
Anesthesiology · 103d