FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
124225–124248 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 09, 1990
BEST LABS MODEL C
K903474 · ESD
Best Labs
Ear, Nose, Throat · 101d
Cleared Nov 09, 1990
PERFECTA TOTAL HIP SYSTEM
K903635 · JDI
Orthomet, Inc.
Orthopedic · 88d
Cleared Nov 09, 1990
QUICK PRIME HEMOCONCEN. NO. HQ-7000 AND CBP-7000Q
K903641 · KDI
Bentley Laboratories, Inc.
Gastroenterology & Urology · 87d
Cleared Nov 09, 1990
WASHINGTON CARDIAC MONITOR
K903710 · DXK
Washington Biolab, Inc.
Cardiovascular · 87d
Cleared Nov 09, 1990
OROSCOPE MODEL NUMBER COS-100
K903718 · EHZ
Cygnus Instruments, Inc.
Dental · 85d
Cleared Nov 09, 1990
THE HAYEK OSCILLATOR
K903745 · BYT
Flexco Medical Instruments
Anesthesiology · 85d
Cleared Nov 09, 1990
PROCERAM PORCELAIN
K903907 · ELL
Nobelpharma USA, Inc.
Dental · 78d
Cleared Nov 09, 1990
CEMPER
K904024 · EMA
Scientific Pharmaceuticals, Inc.
Dental · 71d
Cleared Nov 09, 1990
REP ULTRA HDL,VLDL/LDL CHOLESTEROL SYSTEM
K904035 · LBT
Helena Laboratories
Chemistry · 70d
Cleared Nov 09, 1990
LANCER ORIGINAL, SIERRA, GENERAL PURPOSE
K904092 · EJF
Lancer Orthodontics, Inc.
Dental · 64d
Cleared Nov 09, 1990
PHOTAC-BOND APLICAP
K904097 · EJK
Espe GmbH (Us)
Dental · 64d
Cleared Nov 09, 1990
PERFORMED TEMPLATE W/FRAGRANCE FOR TOOTH POSTIONER
K904128 · KMY
American Orthodontics
Dental · 65d
Cleared Nov 09, 1990
OSSEODENT DENTAL ATTACHMENTS (NON-ANGLED)
K904228 · DZE
Collagen Corp.
Dental · 87d
Cleared Nov 09, 1990
DU PONT DIMENSION(R) SALICYLATE(SAL) METHOD
K904301 · DKJ
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 51d
Cleared Nov 09, 1990
DIOLASE
K904753 · IWE
Scanditronix, Inc.
Radiology · 21d
Cleared Nov 09, 1990
KODATROL I AND II CONTROL AND DILUENT SET
K904768 · JJY
Eastman Kodak Company
Chemistry · 18d
Cleared Nov 08, 1990
FASTIDIOUS MIC PANEL
K901598 · JWY
Microtech Medical Systems, Inc.
Microbiology · 217d
Cleared Nov 08, 1990
TITANIUM GREENFIELD(R) VENA CAVA FILTER W/HOOKS
K901659 · DTK
Boston Scientific Corp
Cardiovascular · 212d
Cleared Nov 08, 1990
BIOPSY NEEDLE TRANSPONDER SYSTEM
K902214 · IYO
Advanced Technology Laboratories, Inc.
Radiology · 176d
Cleared Nov 08, 1990
ELVI 828 DIGICLOT MULTISCAN
K902614 · KQG
Logos Scientific, Inc.
Hematology · 148d
Cleared Nov 08, 1990
LASERDISH SILICONE VENTRICULAR LEAD W/TRAILING TIN
K903221 · DTB
Telectronics Pacing Systems, Inc.
Cardiovascular · 108d
Cleared Nov 08, 1990
VIALON OBTURATOR
K904121 · FOZ
Deseret Medical, Inc.
General Hospital · 63d
Cleared Nov 08, 1990
APTT REAGENT
K904341 · GFO
Sigma Chemical Co.
Hematology · 49d
Cleared Nov 08, 1990
PATIENT EXAMINATION GLOVES
K904936 · LYY
Slim River Latex Sdn. Bhd.
General Hospital · 7d