FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
162193–162216 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Oct 05, 1981
KORICLEAN
K812176
Trans World Agency, Inc.
Physical Medicine · 63d
Cleared Oct 02, 1981
SR-ALGICAP
K811867 · ELW
J. Aderer, Inc.
Dental · 93d
Cleared Oct 02, 1981
LOXLEY EMERGENCY CERVICAL COLLAR
K812019 · IQK
Loxley Medical
Physical Medicine · 81d
Cleared Oct 02, 1981
MLA ELECTRA 700
K812124 · JPA
Medical Laboratory Automation...
Hematology · 67d
Cleared Oct 02, 1981
MINITECK ENTERIC BROTH & ENTEROBACTER
K812286 · JSS
Bd Becton Dickinson Vacutainer...
Microbiology · 50d
Cleared Oct 02, 1981
ISOCENTRIC NEUTRON THERAPY SYSTEMS
K812337 · IWL
The Cyclotron Corp.
Radiology · 45d