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
152857–152880 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 01, 1984
TRIGLYCERIDE REAGENT SET
K841062 · CDT
Medical Specialties, Inc.
Chemistry · 50d
Cleared May 01, 1984
ALBUMIN REAGENT SET
K841063 · CIX
Medical Specialties, Inc.
Chemistry · 50d
Cleared May 01, 1984
ALKALINE PHOSPHOTASE REAGENT SET
K841064 · CIO
Medical Specialties, Inc.
Chemistry · 50d
Cleared May 01, 1984
SGOT REAGENT SET
K841065 · CIQ
Medical Specialties, Inc.
Chemistry · 50d
Cleared May 01, 1984
SGOT-UV REAGENT SET
K841066 · CIT
Medical Specialties, Inc.
Chemistry · 50d
Cleared May 01, 1984
URIC ACID REAGENT SET
K841067 · CDH
Medical Specialties, Inc.
Chemistry · 50d
Cleared May 01, 1984
UREA NITROGEN REAGENT SET
K841068 · CDW
Medical Specialties, Inc.
Chemistry · 50d
Cleared May 01, 1984
SERUM TOTAL PROTEIN REAGENT SET
K841069 · CEK
Medical Specialties, Inc.
Chemistry · 50d
Cleared May 01, 1984
CREATININE REAGENT SET
K841070 · JFY
Medical Specialties, Inc.
Chemistry · 50d
Cleared Apr 30, 1984
PULMOMETER
K831803 · BZG
Kinetics Measurement Corp.
Anesthesiology · 332d
Cleared Apr 30, 1984
RESPIROMETER
K832401 · BZG
Kinetix
Anesthesiology · 285d
Cleared Apr 30, 1984
OMNI INFANT PHOTOTHERAPY UNIT
K834430 · LBI
Rocky Mountain Medical Corp.
General Hospital · 136d
Cleared Apr 30, 1984
MULTI-LUMEN CENTRAL VENOUS CATH. KIT
K834473 · LJS
Burron Medical Products, Inc.
General Hospital · 132d
Cleared Apr 30, 1984
Q3000
K834567 · DQK
Quinton, Inc.
Cardiovascular · 124d
Cleared Apr 30, 1984
FACS ANALYZER
K840195 · GKZ
Bd Becton Dickinson Vacutainer...
Hematology · 103d
Cleared Apr 30, 1984
UTERINE SOUND
K840380 · HHM
Intl. Medical Technologies, Inc.
Obstetrics & Gynecology · 91d
Cleared Apr 30, 1984
TAPERED CERVICAL DILATOR
K840381 · HHI
Intl. Medical Technologies, Inc.
Obstetrics & Gynecology · 91d
Cleared Apr 30, 1984
VACUUM ASPIRATION CATHETER
K840382 · HHI
Intl. Medical Technologies, Inc.
Obstetrics & Gynecology · 91d
Cleared Apr 30, 1984
MENSTRUAL ASPIRATION KIT
K840383 · HHI
Intl. Medical Technologies, Inc.
Obstetrics & Gynecology · 91d
Cleared Apr 30, 1984
DIAGNOSTIC DILATATION & MENSTRUAL KIT
K840384 · HHI
Intl. Medical Technologies, Inc.
Obstetrics & Gynecology · 91d
Cleared Apr 30, 1984
ELECTRO-MESH GLOVE
K840395 · GXY
Whiting & Davis Co.
Neurology · 91d
Cleared Apr 30, 1984
ELECTRO-MESH WRAP
K840396 · GXY
Whiting & Davis Co.
Neurology · 91d
Cleared Apr 30, 1984
AMETHERM
K840526 · FMZ
Egnell, Inc.
General Hospital · 83d
Cleared Apr 30, 1984
MAGNE-DENT
K840600 · EGG
Magne-Dent
Dental · 80d