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
163609–163632 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 04, 1981
ISOLATER THP
K811981 · KOC
Tri-Med, Inc.
Gastroenterology & Urology · 22d
Cleared Aug 04, 1981
RESPIRATION RATE MONITOR 120/121
K812044 · BZQ
Medix Medical Electronics (U.S.A.), Inc.
Anesthesiology · 14d
Cleared Aug 04, 1981
DISPOSABLE PILLOW
K812079 · KME
Carpenter Co.
General Hospital · 13d
Cleared Aug 03, 1981
THREE LEVEL CONTROL SERA
K810459 · DHX
Bd Becton Dickinson Vacutainer...
Immunology · 164d
Cleared Aug 03, 1981
SUNTAN BOOTH
K810796 · FTC
Gibson'S Mfg. Corp.
General & Plastic Surgery · 133d
Cleared Aug 03, 1981
AXICARE BREAST SHELL
K811364 · HFS
Neonatal Corp.
General Hospital · 81d
Cleared Aug 03, 1981
MODEL 84 TRANSPORT SYSTEM
K811372 · DSP
Datascope Corp.
Cardiovascular · 80d
Cleared Aug 03, 1981
NICHOLAS II, VIRAL-BACTERIAL FILTER
K811546 · CAH
K & G Healthcare Ind., Inc.
General Hospital · 63d
Cleared Aug 03, 1981
ACCU-CHEK TRANS-TELEPHONIC PACEMAKER TR
K811758 · DXH
Powers Medical Systmes
Cardiovascular · 42d
Cleared Aug 03, 1981
MODEL D BIPOLAR ENDOCARDIAL LEAD
K811876 · DTB
Cook Pacemaker Corp.
Cardiovascular · 33d
Cleared Aug 03, 1981
MODEL C UNIPOLAR ENDOCARDIAL LEAD
K811877 · DTB
Cook Pacemaker Corp.
Cardiovascular · 33d
Cleared Aug 03, 1981
MODEL B BIPOLAR ENDOCARDIAL LEAD
K811878 · DTB
Cook Pacemaker Corp.
Cardiovascular · 33d
Cleared Aug 03, 1981
MODEL A UNIPOLAR ENDOCARDIAL LEAD
K811879 · DTB
Cook Pacemaker Corp.
Cardiovascular · 33d
Cleared Aug 03, 1981
FLU VEN I.V. SETS
K811914 · FPA
Venusa , Ltd.
General Hospital · 33d
Cleared Aug 03, 1981
OREIA II, B-HCG
K811940 · JHJ
Organon, Inc.
Chemistry · 28d
Cleared Aug 03, 1981
RADIOIMMUNOASSAY, FOLLICLE STIMULATING
K811993 · CGJ
Endocrine-Metabolic Center
Chemistry · 20d
Cleared Aug 03, 1981
PEDIATRIC DOUBLE SWIVEL CONNECTOR
K812000 · BZA
Mallinckrodt Critical Care
Anesthesiology · 20d
Cleared Aug 03, 1981
KODAK EKTACHEM CLIN. CHEM. SLIDES (AMYL)
K812027 · CIW
Eastman Kodak Company
Chemistry · 14d
Cleared Aug 03, 1981
KODAK EKTACHEM CLIN. CHEM. SLIDES (TP)
K812028 · CEK
Eastman Kodak Company
Chemistry · 14d
Cleared Aug 03, 1981
KODAK EKTACHEM CLIN. CHEM. SLIDES (TRIG)
K812029 · CDT
Eastman Kodak Company
Chemistry · 14d
Cleared Aug 03, 1981
KODAK EKTACHEM CLIN. CHEM. SLIDES (ALB)
K812030 · CIX
Eastman Kodak Company
Chemistry · 14d
Cleared Aug 03, 1981
KALLESTAD ANTISERA TO GENTAMICIN
K812050 · DJI
Kallestad Laboratories, Inc.
Toxicology · 13d
Cleared Aug 03, 1981
PERCENTO MASK, PEDIATRIC, UNDER-THE-CHIN
K812066 · BYF
Airlife, Inc.
Anesthesiology · 13d
Cleared Aug 03, 1981
AEGIS I.V. STRIPS
K812080 · KMK
Warner-Lambert Co.
General Hospital · 12d