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
153409–153432 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 22, 1984
C-LITE
K841589 · KYT
Suncoast Medical Manufacturers, Inc.
General Hospital · 34d
Cleared May 22, 1984
STORZ UNIVERSAL EYE SHIELD
K841599 · HOY
Storz Instrument Co.
Ophthalmic · 34d
Cleared May 22, 1984
TERUMO SENSIBEAD THYROXINE EIA KIT
K841601 · KLI
Terumo Medical Corp.
Chemistry · 34d
Cleared May 22, 1984
ACCURATE BETA 30 PREGNANCY TEST KIT
K841602 · LCX
Organon, Inc.
Chemistry · 34d
Cleared May 22, 1984
BLOOD SPOT NEONATAL TSH RADIOIMMUNO
K841606 · JLW
Bd Becton Dickinson Vacutainer...
Chemistry · 33d
Cleared May 22, 1984
DUPONT THEOPHYLLINE ASSAY KIT
K841656 · KLS
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 29d
Cleared May 22, 1984
WUNDERFIL
K841667 · EBF
Harry J. Bosworth Co.
Dental · 29d
Cleared May 22, 1984
DISPOSABLE POLY GLOVES
K841676 · LZA
Abco Dealers, Inc.
General Hospital · 29d
Cleared May 22, 1984
INNOFLUOR PHENYTOIN
K841706 · LGR
Innotron Diagnostics
Chemistry · 29d
Cleared May 22, 1984
SUNGLASSES
K841794 · HQY
Whole Sale Importers
Ophthalmic · 20d
Cleared May 22, 1984
CODE-A-WELL SERIES 300 PLATE
K841937 · LIB
Plastic Injectors, Inc.
Microbiology · 11d
Cleared May 21, 1984
CYTOTOXICITY ASSAY FOR CLOSTRIDIUM-
K833447 · MCB
Bartels Immunodiagnostic Supplies, Inc.
Microbiology · 229d
Cleared May 21, 1984
BLOOD PRESSURE MONITOR BP600X
K834441 · DXN
Lifeline Systems, Inc.
Cardiovascular · 157d
Cleared May 21, 1984
KERR RESIN BONDED BRIDGE CEMENT
K840407 · EMA
Sybron Corp.
Dental · 111d
Cleared May 21, 1984
TYCOS SELF CHECK BPM3 BLOOD PRESS MONI
K840469 · DXN
Sybron Corp.
Cardiovascular · 108d
Cleared May 21, 1984
PHADEXACT SERUM, TOTAL IGE CONTROLS
K840476 · DGC
Pharmacia, Inc.
Chemistry · 108d
Cleared May 21, 1984
EAR KNIVES
K840764 · JYO
Sharpoint, Inc.
Ear, Nose, Throat · 88d
Cleared May 21, 1984
GRAMS ASPIRATOR S-300
K840803 · BTA
Grams Medical, Inc.
General & Plastic Surgery · 87d
Cleared May 21, 1984
VENTRIA APO A-1 ALPHA-1 LIPOTROTEIN
K840830 · DER
Ventrex Laboratories, Inc.
Immunology · 87d
Cleared May 21, 1984
TOXO-G EIA DIAGNOSTIC KIT
K840879 · LGD
Abbott Laboratories
Microbiology · 84d
Cleared May 21, 1984
SODIUM CHLORIDE SOLUTION BLOOD CELL
K841183 · FNW
Reagent Laboratory, Inc.
Hematology · 62d
Cleared May 21, 1984
PLASTIC, STERILE TUBING CLOSED SET
K841185 · FPA
Marbex, Inc.
General Hospital · 62d
Cleared May 21, 1984
INFUSION SET SCALP VEIN
K841186 · FPA
Marbex, Inc.
General Hospital · 62d
Cleared May 21, 1984
RUBELLA IGG ANTIBODY ELISA TEST SYS
K841200 · LFX
Ortho Diagnostic Systems, Inc.
Microbiology · 61d