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
140425–140448 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 13, 1987
S&W ELECTRODE TYPES 888, 844, 988 AND 944
K864586 · DRX
S & W Medico Teknik
Cardiovascular · 112d
Cleared Mar 13, 1987
TDXR CANNABINOIDS
K864751 · LDJ
Abbott Laboratories
Chemistry · 98d
Cleared Mar 13, 1987
MEDICA EASYLYTE SODIUM/POTASSIUM ANALYZER
K864872 · JGS
Medica Corp.
Chemistry · 91d
Cleared Mar 13, 1987
BACPAC (TM), MODEL 6500
K864968 · GZJ
Medical Devices, Inc.
Neurology · 81d
Cleared Mar 13, 1987
PREGELLED DISPOSABLE ELECTRODE, SILVER-SILVER
K865011 · DRX
Labeltape Meditect, Inc.
Cardiovascular · 80d
Cleared Mar 13, 1987
THYROID STIMULATING HORMONE (TSH IRMA) RIA KIT
K865071 · JLW
Immuchem Corp.
Chemistry · 74d
Cleared Mar 13, 1987
AMRESCO FLOW PAC CARBON DIOXIDE (CO2) REAGENTS
K870025 · KMS
American Research Products Co.
Chemistry · 67d
Cleared Mar 13, 1987
THE SCREENER GSI 55 ABR SCREENER
K870030 · GWJ
Grason-Stadler, Inc.
Neurology · 67d
Cleared Mar 13, 1987
COAT-A-COUNT IRMA HCG KIT AND ITS COMPONENTS
K870106 · JHI
Diagnostic Products Corp.
Chemistry · 60d
Cleared Mar 13, 1987
PLATFORM MATTRESS W/DISPOSABLE BEDPAN BAG
K870166 · FNJ
George C. Kuhn
General Hospital · 58d
Cleared Mar 13, 1987
HEARING AID TEST SYSTEM MODEL HAT 1000
K870229 · ETW
Madsen Electronics (Canada) , Ltd.
Ear, Nose, Throat · 51d
Cleared Mar 13, 1987
INTERMATE(TM)
K870242 · FRN
Infusion Systems Corp.
General Hospital · 51d
Cleared Mar 13, 1987
#014460-120 3-WAY & #014461-120 4-WAY STOPCOCK
K870324 · FMG
Clinical Connections, Inc.
General Hospital · 44d
Cleared Mar 13, 1987
EZ COMPLEMENT REAGENTS, 78N2212
K870351 · DHL
Diamedix Corp.
Immunology · 43d
Cleared Mar 13, 1987
INSTAJECT
K870474 · KZH
Pavel Jordan & Associates, Inc.
General Hospital · 38d
Cleared Mar 13, 1987
DEPEND UNDERPAD
K870522 · KME
Kimberly-Clark Corp.
General Hospital · 35d
Cleared Mar 13, 1987
FAST GLUCOSE
K870631 · CGA
Sclavo, Inc.
Chemistry · 28d
Cleared Mar 13, 1987
FAST URIC ACID
K870632 · KNK
Sclavo, Inc.
Chemistry · 28d
Cleared Mar 13, 1987
DAHLBERG MODEL UV TRIMLINE IN-THE-EAR HEARING AID
K870691 · ESD
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 22d
Cleared Mar 13, 1987
AC ADAPTER ACCESSORY, PRODUCT CODE 600123A
K870768 · FRN
Deltec Systems, Inc.
General Hospital · 15d
Cleared Mar 13, 1987
RAICHEM(TM) PHOSPHORUS REAGENT, RAPID ENDPOINT
K870776 · CEO
Reagents Applications, Inc.
Chemistry · 15d
Cleared Mar 13, 1987
PROGRESS PLUS SELECTIVE CHEMISTRY ANALYZER
K870777 · JJF
Kone Instruments, Inc.
Chemistry · 15d
Cleared Mar 13, 1987
EMG ELECTRODES AND EXTENSION CORDS
K870795 · IKT
Nihon Kohden America, Inc.
Neurology · 15d
Cleared Mar 13, 1987
INTERSECT SYSTEMS TRIGLYCERIDE-GPO REAGENT
K870827 · CDT
Intersect Systems, Inc.
Chemistry · 10d