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
163033–163056 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 08, 1981
ISOLATED VOLTAGE/FREQUENCY CONVERTER
K812619 · HCC
Bio-Feedback Systems, Inc.
Neurology · 23d
Cleared Oct 08, 1981
ACA ANTITHROMBIN III TEST PACK
K812627 · JBQ
E.I. Dupont DE Nemours & Co., Inc.
Hematology · 23d
Cleared Oct 08, 1981
ACA FIBRINOGEN TEST PACK
K812629 · KQJ
E.I. Dupont DE Nemours & Co., Inc.
Hematology · 24d
Cleared Oct 08, 1981
DOTRICH ELECTRONIC AIR CLEANER #C500AM
K812656 · FRF
Leedal, Inc.
General Hospital · 20d
Cleared Oct 08, 1981
SELF-CENTERING HIP
K812672 · KWY
Depuy, Inc.
Orthopedic · 16d
Cleared Oct 08, 1981
ADULT FLEX FLOAT W/HEATER
K812681 · FOH
Pharmaquest Corp.
General Hospital · 16d
Cleared Oct 08, 1981
FLEXFLOAT HEATER
K812682 · FOH
Pharmaquest Corp.
General Hospital · 16d
Cleared Oct 08, 1981
ADULT FLEXFLOAT
K812684 · FOH
Pharmaquest Corp.
General Hospital · 16d
Cleared Oct 08, 1981
HEMA 20 MICRON TRANSFUSION BLOOD FILTER
K812697 · CAK
Abbott Laboratories
General Hospital · 16d
Cleared Oct 06, 1981
MYOCATH CATOLOG NO. MCK-A
K812052
Sorensen Research
Physical Medicine · 77d
Cleared Oct 06, 1981
DESERET CATHETER DRESSING
K812073 · KGX
Warner-Lambert Co.
General & Plastic Surgery · 77d
Cleared Oct 06, 1981
INTERMEDICS POLY FLEX EPICARDIAL SUTURE
K812221 · DTB
Intermedics, Inc.
Cardiovascular · 60d
Cleared Oct 06, 1981
INTERMEDICS POLY FLEX ENDOCARDIAL ATRIAL
K812245 · DTB
Intermedics, Inc.
Cardiovascular · 56d
Cleared Oct 06, 1981
EXAFLEX IMPRESSION MATERIAL
K812406 · ELW
G-C Intl. Corp.
Dental · 46d
Cleared Oct 06, 1981
DI-CROWN
K812441 · HQG
Coburn Optical Ind., Inc.
Ophthalmic · 41d
Cleared Oct 06, 1981
MEZLOCILLIN 75 MCG. SENSI-DISC
K812571 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 27d
Cleared Oct 06, 1981
MONO 2 OXYGEN MONITOR
K812587 · CCL
Kantron Cardiovascular, Inc.
Anesthesiology · 25d
Cleared Oct 06, 1981
G-C FIT-CHECKER IMPRESSION MATERIAL
K812679 · ELW
G-C Intl. Corp.
Dental · 14d
Cleared Oct 06, 1981
G-C IMPRESSION SYRINGE
K812680 · EID
G-C Intl. Corp.
Dental · 14d
Cleared Oct 06, 1981
RIA QUANT C-PEPTIDE KIT
K812689 · JKD
Mallinckrodt Critical Care
Chemistry · 14d
Cleared Oct 06, 1981
C-PEPTIDE CONTROL PACK
K812690 · JJX
Mallinckrodt Critical Care
Chemistry · 14d
Cleared Oct 06, 1981
GC DISK
K812698 · JTR
Remel Co.
Microbiology · 14d
Cleared Oct 06, 1981
AMYLASE
K812699 · KHM
Pointe Scientific, Inc.,
Chemistry · 14d
Cleared Oct 06, 1981
PROSANA BELT
K812719 · IQE
Bandwagon, Inc.
Physical Medicine · 11d