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
162145–162168 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 19, 1981
DIRECT IRON REAGENT SET
K812777 · JIY
The Dow Chemical Co.
Chemistry · 14d
Cleared Oct 16, 1981
DRESSING CHANGE TRAYS & STERILE SPONGES
K811951 · EFQ
O.R. Specialties, Inc.
General & Plastic Surgery · 101d
Cleared Oct 14, 1981
PROXIMAL INTERPHALANGEAL JOINT IMPLANT
K802342 · JDI
Sutter Biomedical, Inc.
Orthopedic · 383d
Cleared Oct 14, 1981
BIO-TONE MODEL 4
K811737 · IPF
Biotone International, Inc.
Physical Medicine · 117d
Cleared Oct 14, 1981
OPERATING ROOM KIT
K811916 · FSM
American Hospital Supply Corp.
General & Plastic Surgery · 105d
Cleared Oct 14, 1981
EARSCAN
K812529 · EWO
Micro Audiometrics Corp.
Ear, Nose, Throat · 42d
Cleared Oct 14, 1981
TEMP-FILL
K812532 · EMA
Madrid Uso, Jr., D.D.S.
Dental · 42d
Cleared Oct 13, 1981
ATRIAL ENDOCARDIAL ELECTRODE LEAD OF J
K811593 · DTB
Telectronics, Inc.
Cardiovascular · 127d
Cleared Oct 13, 1981
TROCAR & TROCAR SLEEVES
K812199 · HET
Reznik Instruments
Obstetrics & Gynecology · 70d
Cleared Oct 13, 1981
ELECTROSURGICAL UNIT
K812203 · GEI
Reznik Instruments
General & Plastic Surgery · 70d
Cleared Oct 13, 1981
UTERINE MANIPULATORS
K812204 · KOH
Reznik Instruments
Obstetrics & Gynecology · 70d
Cleared Oct 13, 1981
LAPAROSCOPE
K812206 · HET
Reznik Instruments
Obstetrics & Gynecology · 70d
Cleared Oct 13, 1981
KALOS-03
K812218 · DXY
Biotronik Sales, Inc.
Cardiovascular · 68d
Cleared Oct 13, 1981
TOUCHLESS HOME-CATH
K812281 · KOD
Diamed Division Ill. Tool Works, Inc.
Gastroenterology & Urology · 61d
Cleared Oct 13, 1981
DORROS-SPRING PRESSURIZER
K812304 · MAV
Cardiovascular Diagnostic Services
Cardiovascular · 56d
Cleared Oct 13, 1981
4001 CT SCANNER
K812393 · JAK
Omnimedical
Radiology · 54d
Cleared Oct 13, 1981
SUNLAMP
K812446 · FTC
The Richmond Light Co.
Radiology · 46d
Cleared Oct 13, 1981
TANDEM QUALITATIVE HCG KIT
K812461 · JHI
Hybritech, Inc.
Chemistry · 43d
Cleared Oct 13, 1981
IMPLANTAID LEAD INTRODUCER #319-10 & 12
K812502 · DYB
Intermedics, Inc.
Cardiovascular · 42d
Cleared Oct 13, 1981
CT/T 8800
K812509 · JAK
General Electric Co.
Radiology · 41d
Cleared Oct 13, 1981
CARDIAC PACING ELECTRODES
K812517 · LDF
Medics Instrument Corp.
Cardiovascular · 41d
Cleared Oct 13, 1981
TRANSDUCER DOME
K812530 · DRS
Biomeal Corp.
Cardiovascular · 41d
Cleared Oct 13, 1981
PRE-BYPASS FILTER
K812539 · KRJ
Gelman Sciences, Inc.
Cardiovascular · 40d
Cleared Oct 13, 1981
LATERAL ANGULATING FLUORO SUSPENSION SYS
K812561 · JAA
General Electric Co.
Radiology · 35d