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
174049–174072 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 22, 1977
SKIN SCRUB PREP SET
K770796 · KKX
Lukens Corp.
General Hospital · 51d
Cleared Jun 22, 1977
TRAY, IRRIGATION, STERILE, BASIC
K770799 · KKX
Lukens Corp.
General Hospital · 51d
Cleared Jun 22, 1977
PHENOBARBITAL ANALYTICAL TEST PACKS
K770919 · DLZ
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 34d
Cleared Jun 22, 1977
TOTAL THYROXINE (RIA) REAGENT SET
K770940 · CDX
The Dow Chemical Co.
Immunology · 29d
Cleared Jun 22, 1977
HUMAN REFERENCE SERUM
K770965
Kallestad Laboratories, Inc.
Immunology · 26d
Cleared Jun 22, 1977
MULTISONIC (DELUXE) CODE TDM
K771029 · ESD
Qualitone
Ear, Nose, Throat · 13d
Cleared Jun 22, 1977
BLADES, SCALPEL
K771045 · GES
American Safety Razor Co.
General & Plastic Surgery · 12d
Cleared Jun 22, 1977
VENA CAVA UMBRELLA FILTER, MODEL 7321
K771046 · DTK
Edwards Laboratories
Cardiovascular · 12d
Cleared Jun 20, 1977
PRESERVE LUBRICANT CODE NO. 43=4035
K770498 · KMJ
Codman & Shurtleff, Inc.
General Hospital · 98d
Cleared Jun 20, 1977
NEEDLE, BIOPSY, BOYD, LUNG
K770523
Cook, Inc.
Pathology · 94d
Cleared Jun 20, 1977
CONNECTORS
K770596 · FPK
Abco Dealers, Inc.
General Hospital · 84d
Cleared Jun 20, 1977
TOOTHBRUSH, REACH
K770749 · EFW
Johnson & Johnson Professionals, Inc.
Dental · 56d
Cleared Jun 20, 1977
GENERATOR, PULSE, UNIPOLAR, #508
K770880 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 35d
Cleared Jun 20, 1977
GENERATOR, PULSE, BIPOLAR 3608
K770881 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 35d
Cleared Jun 20, 1977
NEURO-SORB PATTIES
K770894 · HBA
Instranetics, Inc.
Neurology · 35d
Cleared Jun 20, 1977
CARDIAC PACERS W/NARROW PULSE WIDTH
K770951 · DXY
Cordis Corp.
Cardiovascular · 26d
Cleared Jun 20, 1977
SYRINGE, ENDODONTIC, W/PERFORATED NEEDLE
K770967 · EIC
National Patent Development Corp.
Dental · 20d
Cleared Jun 20, 1977
DENTAL PLAQUE DISCLOSING AGENT
K770990 · QJC
Evident Dental Co. , Ltd.
Dental · 20d
Cleared Jun 20, 1977
PRO-CARE
K770997 · JEQ
Young Dental Manufacturing Co. 1, LLC
Dental · 19d
Cleared Jun 20, 1977
ARTICULATING PAPER
K771011 · EFH
Parker Laboratories, Inc.
Dental · 14d
Cleared Jun 20, 1977
HUANG VEIN HOLDER, #21-8011
K771026 · DWS
Codman & Shurtleff, Inc.
Cardiovascular · 12d
Cleared Jun 17, 1977
PROPHALACTICS
K770412 · HIS
Jamar Health Products
Obstetrics & Gynecology · 105d
Cleared Jun 17, 1977
ATYPIA PROFILE MONITOR
K770550 · GKZ
Geometric Data, Div. Smithkline Corp.
Hematology · 88d
Cleared Jun 17, 1977
DETER. OF PHOSPHOHEXOSE ISOMERASE
K770577 · KLJ
Sigma Chemical Co.
Chemistry · 81d