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
155449–155472 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 27, 1983
DENTIN BONDING AGENT
K833473 · KLE
Johnson & Johnson Professionals, Inc.
Dental · 82d
Cleared Dec 27, 1983
VIRALIZER NEBULIZER SPRAYER
K833474 · CCQ
Viral Response System, Inc.
Anesthesiology · 82d
Cleared Dec 27, 1983
INTERSEPT 40 MICRON FILTER W/TUBING
K833476 · DTM
Extracorporeal Medical Specialities,...
Cardiovascular · 81d
Cleared Dec 27, 1983
INTERSEPT 40 MICRON FILTER
K833477 · DTM
Extracorporeal Medical Specialities,...
Cardiovascular · 81d
Cleared Dec 27, 1983
PARTIAL DENTURE ALLOY
K833512 · EJH
Dentsply Intl.
Dental · 77d
Cleared Dec 27, 1983
COMFEEL CLEANSER
K833566 · EXB
Coloplast A/S
Gastroenterology & Urology · 76d
Cleared Dec 27, 1983
COMFEEL BARRIER CREAM
K833569 · EXB
Coloplast A/S
Gastroenterology & Urology · 76d
Cleared Dec 27, 1983
PULSATOR ARTERIAL BLOOD SAMPLING SYRIN
K833582 · CBT
Concord Laboratories, Inc.
Anesthesiology · 76d
Cleared Dec 27, 1983
X-BEAM FILM 3TC
K833592
Amorient Ent.
Dental · 76d
Cleared Dec 27, 1983
DERMATEX STERILE FINGER BANDAGE
K833638 · NAD
Dermatec, Inc.
General & Plastic Surgery · 71d
Cleared Dec 27, 1983
ANGIO-SET INTRAVENOUS CATH. SET
K833657 · FOZ
Deseret Medical, Inc.
General Hospital · 70d
Cleared Dec 27, 1983
ARMBOARD AND THE BOARD
K833664 · BTX
Rick Robbin & Frederick Auerbach
General & Plastic Surgery · 70d
Cleared Dec 27, 1983
CHEM KIT THEOPHYLLINE DIAG. KIT
K833683 · KLS
Abbott Laboratories
Toxicology · 57d
Cleared Dec 27, 1983
IVEX-INT
K833684 · FPB
Abbott Laboratories
General Hospital · 57d
Cleared Dec 27, 1983
ACA THYROXINE CALIBRATOR
K833700 · JIT
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 70d
Cleared Dec 27, 1983
EMIT NETILMICIN ASSAY
K833715 · LCE
Syva Co.
Toxicology · 67d
Cleared Dec 27, 1983
NON - ADHERENT BANDAGE
K833733 · FRO
American Medical Disposable, Inc.
General & Plastic Surgery · 63d
Cleared Dec 27, 1983
LEAP STREP TEST KIT
K833738 · GTP
Cooper Biomedical, Inc.
Immunology · 63d
Cleared Dec 27, 1983
VENOSET MULTI-MED PIGGYBACK W/IVEX-2
K833740 · FPA
Abbott Laboratories
General Hospital · 62d
Cleared Dec 27, 1983
PERITONEAL CATHETER-CHANGES-
K833749 · FKX
Quinton, Inc.
Gastroenterology & Urology · 62d
Cleared Dec 27, 1983
CURITY 100% SILICONE COUDE' CATHETER
K833790 · KOD
The Kendal Co.
Gastroenterology & Urology · 57d
Cleared Dec 27, 1983
CARDIAC CAMERA
K833811 · IYX
Siemens Gammasonics, Inc.
Radiology · 104d
Cleared Dec 27, 1983
BIOTHERM
K833839 · ILJ
Trileen, Inc.
Physical Medicine · 54d
Cleared Dec 27, 1983
TUCK-TITE COLON FLUID RETAINER
K833860 · FCE
Clayton Medical Products, Inc.
Gastroenterology & Urology · 50d