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
132025–132048 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 09, 1989
RESUSCITATOR'S GUARD SUCTION CONTROL SYSTEM
K884917 · IZH
Amg Medical Equipments, Inc.
Radiology · 101d
Cleared Mar 09, 1989
M55 K KARAYA GUM DISP. MICROTAPE ECG ELECTRODE, 55
K884983 · DRX
S & W Medico Teknik
Cardiovascular · 100d
Cleared Mar 09, 1989
M40 K KARAYA GUM DISP. MICROTAPE ECG ELECTRODE, 40
K884984 · DRX
S & W Medico Teknik
Cardiovascular · 100d
Cleared Mar 09, 1989
MICRO-FINE HIGH FREQ. MOBILE MAMMO. SYSTEM MF-150
K885135 · IZH
Bennett X-Ray Corp.
Radiology · 84d
Cleared Mar 09, 1989
ENDOSCOPIC LIGHT SOURCE
K885183 · HRX
Technology For Imaging, Inc.
Orthopedic · 86d
Cleared Mar 09, 1989
ROCKET ENDOCERVICAL BRUSH
K885274 · HHT
A & A Medical, Inc.
Obstetrics & Gynecology · 77d
Cleared Mar 09, 1989
CALIUS-ISABEL CANOVAS SUNGLASSES
K890081 · HQY
Roseburg SA
Ophthalmic · 58d
Cleared Mar 09, 1989
TARGET(TM) QUANTITATIVE HCG
K890131 · JHI
V-Tech, Inc.
Chemistry · 56d
Cleared Mar 09, 1989
TOTAL PROTEIN REAGENT
K890278 · CEK
Sigma Chemical Co.
Chemistry · 50d
Cleared Mar 09, 1989
TRIGLYCERIDES - GPO REAGENT
K890337 · CDT
Alpkem Corp.
Chemistry · 45d
Cleared Mar 09, 1989
IMX B2-MICROGLOBULIN
K890421 · JZG
Abbott Laboratories
Immunology · 42d
Cleared Mar 09, 1989
ALASTIGARD
K890529 · EJF
Unitek Corp.
Dental · 35d
Cleared Mar 09, 1989
WELLSHIRE BASELINK
K890558 · DXH
American Executive Technology
Cardiovascular · 31d
Cleared Mar 09, 1989
ULTIMA LITE
K890568 · EJT
Deringer-Ney, Inc.
Dental · 31d
Cleared Mar 09, 1989
NEYORO 65CF
K890569 · EJT
Deringer-Ney, Inc.
Dental · 31d
Cleared Mar 09, 1989
KENLOR HUMAN SPINAL FLUID CONTROL LIQUID
K890576 · JJY
Kenlor Industries, Inc.
Chemistry · 31d
Cleared Mar 09, 1989
KENLOR LIQUID URINE CONTROL
K890577 · JJW
Kenlor Industries, Inc.
Chemistry · 31d
Cleared Mar 09, 1989
BTE HEARING AID OTICON MODEL: E42P
K890704 · ESD
Oticon Corp.
Ear, Nose, Throat · 27d
Cleared Mar 09, 1989
MEDIMOD(TM), MODEL 8900
K890705 · GZJ
Medical Devices, Inc.
Neurology · 27d
Cleared Mar 09, 1989
ABUSCREEN FP FOR BARBITURATES
K890884 · DIS
Roche Diagnostic Systems, Inc.
Toxicology · 16d
Cleared Mar 09, 1989
HYCOR SENTRY DRUGS OF ABUSE URINE CONTROL:
K890957 · DIF
Hycor Biomedical, Inc.
Toxicology · 10d
Cleared Mar 08, 1989
DELFIA HLH SPEC KIT
K883814 · CEP
Pharmacia, Inc.
Chemistry · 181d
Cleared Mar 08, 1989
PREEMICARE SERIES 4000 PHOTOTHERAPY LAMP
K884133 · LBI
Preemicare Corp.
General Hospital · 159d
Cleared Mar 08, 1989
C&T PREGNANCY TEST KIT
K884489 · LCX
Healthcheck Corp.
Chemistry · 133d