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
153649–153672 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 02, 1984
IMMPULSE GENTAMICIN ASSAY REAGENTS
K841162 · LCQ
Paragon Diagnostics, Inc.
Toxicology · 44d
Cleared May 02, 1984
URO-MALE INCONTINENCE CATHETER
K841224 · KNX
Gil-Med Industries C/O Kegan & Kegan,...
Gastroenterology & Urology · 41d
Cleared May 02, 1984
ASSIGNED VALUE FOR MEAN PLATELET
K841239 · JPK
Coulter Electronics, Inc.
Hematology · 40d
Cleared May 02, 1984
SPC DISPOSABLE CUTTER
K841247 · FZT
Surgical Products Corp.
General & Plastic Surgery · 42d
Cleared May 02, 1984
STA-POTENT SYSTEM
K841257 · LKY
Nu-Potent
Gastroenterology & Urology · 37d
Cleared May 02, 1984
ELVI 18
K841288 · JJN
Logos Scientific, Inc.
Chemistry · 35d
Cleared May 02, 1984
BIERMAN BIOPSY NEEDLE
K841299 · GDM
Popper & Sons, Inc.
General & Plastic Surgery · 33d
Cleared May 02, 1984
DIRECTIGEN MENNINGITIS TEST KIT
K841308 · GTI
Bd Becton Dickinson Vacutainer...
Microbiology · 33d
Cleared May 02, 1984
SPC ARTHROSCOPY TABLE
K841328
Surgical Products Corp.
General & Plastic Surgery · 50d
Cleared May 02, 1984
RIM ONPG KIT
K841329 · JTO
Austin Biological Laboratories
Microbiology · 30d
Cleared May 02, 1984
PROGESTERONE DIRECT RIA KIT-RADIOIMM
K841333 · JLS
Biotecx Laboratories, Inc.
Chemistry · 30d
Cleared May 02, 1984
LARYNGEAL STENT
K841347 · FWN
E. Benson Hood Laboratories, Inc.
Ear, Nose, Throat · 30d
Cleared May 02, 1984
UMBRELLA KEEL
K841348
E. Benson Hood Laboratories, Inc.
Gastroenterology & Urology · 30d
Cleared May 02, 1984
ND1200 RIA COUNTER
K841352 · JJJ
Nuclear Data, Inc.
Chemistry · 30d
Cleared May 02, 1984
WELLCOGEN S. PNEUMONIAE
K841376 · GWC
Wellcome Diagnostics
Microbiology · 29d
Cleared May 02, 1984
VENT-WELL VENTILATOR TUBING
K841378 · BZO
Airmed Corp.
Anesthesiology · 29d
Cleared May 02, 1984
RIM-DNASE KIT
K841389 · JSF
Austin Biological Laboratories
Microbiology · 29d
Cleared May 02, 1984
CODE-A-WELL
K841390 · LIB
Plastic Injectors, Inc.
Microbiology · 29d
Cleared May 02, 1984
DIFFERENTIATION DISKS SPECTINOMYCIN
K841453 · JTO
Difco Laboratories, Inc.
Microbiology · 23d
Cleared May 02, 1984
RIM GARDNERELLA VAGINALIS KIT
K841460 · JTO
Austin Biological Laboratories
Microbiology · 23d
Cleared May 02, 1984
COAGULATION CONTROL PLASMA LEVEL 1/2/3
K841461 · GGP
Diatech, Inc.
Hematology · 23d
Cleared May 02, 1984
DECALCIFIER I
K841488 · KDX
Surgipath Medical Industries, Inc.
Pathology · 22d
Cleared May 02, 1984
ACA TRICYCLIC ANTIDEPRESSANTS SCREEN TES
K841532 · LFG
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 16d
Cleared May 02, 1984
MODEL 3000 HYPERBARIC CHAMBER
K841608 · CBF
Custom Craft Products, Inc.
Anesthesiology · 13d