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
162481–162504 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 09, 1981
BABY CHICK BLOOD IN ALSEVER'S
K812375 · LHT
Dutchland Laboratories, Inc.
Immunology · 20d
Cleared Sep 09, 1981
SHEEP BLOOD IN ALSEVER'S, CITR., DEFIBR
K812376 · LHT
Dutchland Laboratories, Inc.
Immunology · 20d
Cleared Sep 09, 1981
DIGITRON ELECTRONIC THERMOMETERS - 4700
K812387 · FLL
Ercona Corp.
General Hospital · 20d
Cleared Sep 09, 1981
UNSCENTED MENSTRUAL PADS
K812402 · HHD
Procter & Gamble Mfg. Co.
Obstetrics & Gynecology · 20d
Cleared Sep 09, 1981
SCENTED MENSTRUAL PADS
K812403 · HHL
Procter & Gamble Mfg. Co.
Obstetrics & Gynecology · 20d
Cleared Sep 09, 1981
BUTTERFLY NEEDLE ASSEMBLY
K812404 · FMI
Nu Tech Medical Systems
General Hospital · 20d
Cleared Sep 09, 1981
KALLESTAD ANTISERA TO TOBRAMYCIN
K812415 · KLB
Kallestad Laboratories, Inc.
Microbiology · 9d
Cleared Sep 09, 1981
BLOOD UREA NITROGEN(BUN-UV)
K812417 · CDQ
Reagents Applications, Inc.
Chemistry · 16d
Cleared Sep 09, 1981
URIC ACID REAGENT SET
K812430 · KNK
Pointe Scientific, Inc.,
Chemistry · 15d
Cleared Sep 09, 1981
AMYLASE REAGENT KIT
K812447 · KHM
Bioscientific
Chemistry · 12d
Cleared Sep 09, 1981
ALKALINE PHOSPHATASE
K812452 · CJE
Pointe Scientific, Inc.,
Chemistry · 12d
Cleared Sep 08, 1981
SCOPE MASTER
K811270 · HIH
Synemed, Inc.
Obstetrics & Gynecology · 125d
Cleared Sep 08, 1981
DYNA- MO
K811629 · IYX
Philips Medical Systems (Cleveland),...
Radiology · 91d
Cleared Sep 08, 1981
MULTI-PURPOSE DENTAL SYRINGE
K811831 · EJI
Centrix, Inc.
Dental · 71d
Cleared Sep 08, 1981
MEDISYSTEMS FISTULA NEEDLE
K811838 · FIE
Medisystems Corp.
Gastroenterology & Urology · 69d
Cleared Sep 08, 1981
MEDISYSTEM NEGATIVE PRESSURE
K811839 · FJK
Medisystems Corp.
Gastroenterology & Urology · 69d
Cleared Sep 08, 1981
MODEL SIX BEAM SYSTEM
K811848 · GWF
Braintech, Inc.
Neurology · 69d
Cleared Sep 08, 1981
NOVAMETRIX PHYSIOLOGICAL MONITOR #910
K811893 · DRT
Novametrix Medical Systems, Inc.
Cardiovascular · 69d
Cleared Sep 08, 1981
UROFLOWMETER
K811925 · FFG
C.R. Bard, Inc.
Gastroenterology & Urology · 68d
Cleared Sep 08, 1981
J & S IRON SATURATING REAGENT
K811942 · JQF
Thyroid Diagnostics, Inc.
Toxicology · 63d
Cleared Sep 08, 1981
LEGIONELLA DIRECT FLUORESCENT ANTIBODY
K812006 · LHL
Centers For Disease Control and...
Microbiology · 54d
Cleared Sep 08, 1981
LEGIONELLA INDIRECT FLUOR. ANTIBODY
K812007 · LHL
Centers For Disease Control and...
Microbiology · 54d
Cleared Sep 08, 1981
PHOTOLITE AOLITE TINTOMATIC LENS
K812051 · HQG
American Optical Corp.
Ophthalmic · 49d
Cleared Sep 08, 1981
PROPOSED CONTROLS FOR DOSIMETRIC RELEASE
K812068 · LIB
Hexcel Medical
Microbiology · 49d