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

Filters: Cleared only ×
176,076 results
170833–170856 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 15, 1979
POST EXTRA SYSTOLIC POTENTIATOR
K781819 · DQO
Medrad, Inc.
Cardiovascular · 80d
Cleared Jan 15, 1979
LEAD, SUTURELESS MYOCARDIAL
K782087 · DTB
Daig Corp.
Cardiovascular · 32d
Cleared Jan 15, 1979
CATHETERS, H-H VENTRICULAR
K782105 · JXG
Holter-Hausner Intl.
Neurology · 27d
Cleared Jan 15, 1979
PULSETAKER
K782131 · DRT
Van, Cott, Bagley, Cornwall & Mccarth
Cardiovascular · 19d
Cleared Jan 15, 1979
DISPOSABLE HOLDER FOR BIOPROSTHESIS
K790022 · DTJ
Edwards Laboratories
Cardiovascular · 12d
Cleared Jan 11, 1979
AUTOMATIC BLOOD PRESSURE DEVICE
K781517 · DXN
Welch Allyn, Inc.
Cardiovascular · 132d
Cleared Jan 10, 1979
HEPARSORB
K781781 · GJA
General Diagnostics
Hematology · 83d
Cleared Jan 10, 1979
BUN
K781782 · CDQ
Gilford Diagnostics
Chemistry · 83d
Cleared Jan 10, 1979
FERRITIN KIT
K781844 · JMG
Ria Products, Inc.
Chemistry · 70d
Cleared Jan 10, 1979
ASSAY SYSTEM, FERRITIN I KIT
K781888 · JMG
New England Nuclear
Chemistry · 64d
Cleared Jan 10, 1979
STAT KIT, MICROPROTEIN
K781897 · CEK
Pierce Chemical Co.
Chemistry · 58d
Cleared Jan 10, 1979
CALCITONIN 125
K781909 · JKR
Cambridge Nuclear Radiopharmaceutical
Chemistry · 57d
Cleared Jan 10, 1979
DATA MODULE
K781915 · KIE
Waters Assoc., Inc.
Chemistry · 57d
Cleared Jan 10, 1979
RIA KIT, GAMMADAB ESTRIOL
K781938 · CGI
Clinical Assays, Inc.
Chemistry · 51d
Cleared Jan 10, 1979
REAGENT KIT, TRIGLYCERIDES
K781939 · CDT
Beckman Instruments, Inc.
Chemistry · 51d
Cleared Jan 10, 1979
RIA KIT, FERRITIN SOLID PHASE
K781946 · JMG
Bd Becton Dickinson Vacutainer...
Chemistry · 50d
Cleared Jan 10, 1979
CRYOSURGICAL DEVICE 2000
K781956 · GEH
Valleylab, Inc.
General & Plastic Surgery · 50d
Cleared Jan 10, 1979
ANALYTICAL TEST PACK, PRIMIDONE
K781957 · DJD
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 50d
Cleared Jan 10, 1979
ANALYTICAL TEST PACK, CARBAMAZEPINE
K781958 · KLT
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 50d
Cleared Jan 10, 1979
SURGICAL GOWNS, SHEETS
K781959 · KKX
Convertors
General Hospital · 50d
Cleared Jan 10, 1979
HORMONE KIT, PARATHYROID
K782010 · CEW
Nichols Institute Diagnostics
Chemistry · 40d
Cleared Jan 10, 1979
ANALYZER ABA-200
K782014 · JJE
Abbott Laboratories
Chemistry · 36d
Cleared Jan 10, 1979
MONITOR HS8
K782044 · BZQ
Scientific & General Pty. , Ltd.
Anesthesiology · 33d
Cleared Jan 10, 1979
MONITOR HS7
K782045 · BZQ
Scientific & General Pty. , Ltd.
Anesthesiology · 33d