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
164809–164832 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 31, 1981
AQUEOUS TRIOLEIN STANDARDS & KITS
K810742 · JIS
Supelco, Inc.
Chemistry · 12d
Cleared Mar 31, 1981
LECITHIN-SPINGOMYELIN STAND. & KITS
K810743 · JIS
Supelco, Inc.
Chemistry · 12d
Cleared Mar 31, 1981
DOUBLE LUMEN SUBCLAVIN CATHETER SC-400
K810745 · LFJ
Vas-Cath of Canada , Ltd.
Gastroenterology & Urology · 12d
Cleared Mar 31, 1981
AIRWAY PRESSURE MONITOR
K810753 · CAP
Impact Instrumentation, Inc.
Anesthesiology · 11d
Cleared Mar 31, 1981
LUTENIZING HORMONES
K810754 · CEP
Pcl-Ria, Inc.
Chemistry · 11d
Cleared Mar 31, 1981
UROLOGIC TUBE HOLDER
K810787 · OCV
The Urology Group
Gastroenterology & Urology · 8d
Cleared Mar 31, 1981
PENTAX COLONOSCOPE MODEL FC-34 MA
K810791 · FDF
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 8d
Cleared Mar 30, 1981
LITRONIC STIMULATOR
K810225 · IPF
Med-Western Electronics, Inc.
Physical Medicine · 62d
Cleared Mar 30, 1981
DRESSING CHANGE TRAY-MEDIUM
K810570 · LDQ
Associated Medical Products Co.
General & Plastic Surgery · 27d
Cleared Mar 27, 1981
GANZ CORONARY REPERFUSION CATHETER
K803270 · DQO
American Edwards Laboratories
Cardiovascular · 88d
Cleared Mar 27, 1981
TERFUSION FINAL FILTER SET
K810113 · FPB
Terumo Medical Corp.
General Hospital · 80d
Cleared Mar 27, 1981
17B ESTRADIOL
K810204 · CHP
Pantex, Div. Bio-Analysis, Inc.
Chemistry · 60d
Cleared Mar 27, 1981
SWAN-GANZ FLOW-DIRECTED THERMODILUTION
K810352 · DYG
American Edwards Laboratories
Cardiovascular · 45d
Cleared Mar 27, 1981
710 FLUOROMETER/DENSITOMETER
K810619 · JQT
Corning Medical & Scientific
Chemistry · 18d
Cleared Mar 27, 1981
HUMAN PLACENTAL LACTOGEN RADIOIMMUNO-
K810625 · DHI
Serono Laboratories, Inc.
Chemistry · 18d
Cleared Mar 27, 1981
DPM CALCULATOR
K810631 · JQP
Iso-Data, Inc.
Chemistry · 17d
Cleared Mar 27, 1981
VINYL ICE BAG
K810653 · KYR
First Industries, Inc.
General Hospital · 17d
Cleared Mar 27, 1981
STOPPERLESS HOT/COLD RUBBER WATER BOTTLE
K810654 · FDF
First Industries, Inc.
Gastroenterology & Urology · 17d
Cleared Mar 27, 1981
CATHDAMP
K810661 · DRS
Medline Industries, Inc.
Cardiovascular · 16d
Cleared Mar 27, 1981
LEECO FSH-QUANT DIAGNOSTIC KIT
K810663 · CGJ
Leeco Diagnostics, Inc.
Chemistry · 16d
Cleared Mar 27, 1981
ARROW RADIAL ARTERY CATHETERIZATION SET
K810675 · DQX
Arrow Intl., Inc.
Cardiovascular · 15d
Cleared Mar 27, 1981
PHYSIOLOGIC RECORDER
K810696 · DPS
Honeywell, Inc.
Cardiovascular · 11d
Cleared Mar 27, 1981
MODEL SP5107 THERMODILUTION CATHETER
K810730 · KRB
Gould, Inc.
Cardiovascular · 10d
Cleared Mar 27, 1981
MODEL IM1000 INTEGRATED MONITOR
K810731 · DQK
Gould, Inc.
Cardiovascular · 10d