Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
153697–153720 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 01, 1984
GLUCOSE ENZYMATIC REAGENT SET
K841055 · CGA
Medical Specialties, Inc.
Chemistry · 50d
Cleared May 01, 1984
HDL PRECIPITANT REAGENT SET
K841056 · JHM
Medical Specialties, Inc.
Chemistry · 50d
Cleared May 01, 1984
LDH-UV REAGENT SET
K841058 · CFJ
Medical Specialties, Inc.
Chemistry · 50d
Cleared May 01, 1984
SGPT REAGENT SET
K841059 · CKD
Medical Specialties, Inc.
Chemistry · 50d
Cleared May 01, 1984
SGPT REAGENT SET
K841060 · CKA
Medical Specialties, Inc.
Chemistry · 50d
Cleared May 01, 1984
PHOPHORUS REAGNET SET
K841061 · CEO
Medical Specialties, Inc.
Chemistry · 50d
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