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.

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

Filters: Cleared only ×
175,820 results
141337–141360 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 19, 1987
APPLISCOPE
K864978 · DPS
Grandcor Medical Systems
Cardiovascular · 59d
Cleared Feb 19, 1987
ULTRASONIC SCALER 3000/ PROPHY-JET 30/ CAVI-JET 30
K864996 · ELC
Dentsply Intl.
Dental · 59d
Cleared Feb 19, 1987
ASTRA T2, T4 AND T6
K865013 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 58d
Cleared Feb 19, 1987
AUSTENAL CONDENSING INSTRUMENT
K865025 · EKG
Austenal Dental, Inc.
Dental · 58d
Cleared Feb 19, 1987
ESPE CHELON-SILVER
K865028 · EBF
Espe GmbH (Us)
Dental · 58d
Cleared Feb 19, 1987
ELECTROCARDIOGRAPH
K865031 · DPS
Nihon Kohden America, Inc.
Cardiovascular · 58d
Cleared Feb 19, 1987
PREGELLED DISPOS. ELECTRODE,SILVER-SILVER CHLORIDE
K865090
Labeltape Meditect, Inc.
Cardiovascular · 51d
Cleared Feb 19, 1987
DEN-MAT SECURE ANTI-ROTATIONAL POST-CORE SYSTEM
K870130 · ELR
Den-Mat Corp.
Dental · 38d
Cleared Feb 19, 1987
DURA ORTHO ACRYLIC
K870148 · EBI
Reliance Dental Mfg. Co.
Dental · 37d
Cleared Feb 19, 1987
ENDOBRUSH
K870177 · EKS
C & S Microinstruments , Ltd.
Dental · 35d
Cleared Feb 19, 1987
NEXADENT (DENTAL CEMENT)
K870209 · EMA
Bionexus, Inc.
Dental · 30d
Cleared Feb 19, 1987
BOSTON POST CEMENT
K870334 · EMA
Scientific Pharmaceuticals, Inc.
Dental · 22d
Cleared Feb 19, 1987
GEM ORTHODONTIC BRACKET
K870536 · EJF
Ormco Corp.
Dental · 10d
Cleared Feb 19, 1987
X-RAY APRON
K870563 · EAJ
X-Tech, Ltd.
Radiology · 9d
Cleared Feb 18, 1987
SPARK-KIT(TM)
K864509
Lyphomed, Inc.
General Hospital · 96d
Cleared Feb 18, 1987
SERALYZER GLUCOSE (HK) REAGENT STRIPS,MODULE,CALI.
K864530 · CGA
Miles Laboratories, Inc.
Chemistry · 93d
Cleared Feb 18, 1987
SIMULTRAC FREE T4[57CO]/TSH MAB[125I]
K864838 · CEC
Bd Becton Dickinson Vacutainer...
Chemistry · 71d
Cleared Feb 18, 1987
JMS HALO APPLICATION TRAY
K864969 · KDD
Jerome Medical
General & Plastic Surgery · 58d
Cleared Feb 18, 1987
SERA-TEK MICROSOMAL ANTIBODY TEST
K865053 · JZO
Miles Laboratories, Inc.
Chemistry · 56d
Cleared Feb 18, 1987
NEW SECOND FRENCH SIZE MAHURKAR CATHETER
K865096 · LFK
Quinton, Inc.
Gastroenterology & Urology · 50d
Cleared Feb 18, 1987
REFLOTRON(R) AST (GOT)
K870246 · CIT
Boehringer Mannheim Corp.
Chemistry · 28d
Cleared Feb 18, 1987
MONITORX LASERX THEOPHYLLINE REAGENT SET
K870277 · LGS
American Monitor Corp.
Toxicology · 22d
Cleared Feb 17, 1987
MODI. OF DENTAL CERAMIC FOR FABRICATION OF CROWN
K864724 · ELL
Dentsply Intl.
Dental · 77d
Cleared Feb 17, 1987
DOLPHIN UMBILICAL CORD CLAMP
K870446 · HFW
Andermac, Inc.
Obstetrics & Gynecology · 14d