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

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176,076 results
165457–165480 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 16, 1981
HUMAN GROWTH HORMONE-RADIOIMM. KIT
K803280 · CFL
Immuno Nuclear Corp.
Chemistry · 18d
Cleared Jan 16, 1981
AUTOMATED ELECTROPHORESIS SYSTEM
K803281 · JJN
Helena Laboratories
Chemistry · 18d
Cleared Jan 16, 1981
PHOTOMETER
K803285 · JJQ
Turner Designs, Inc.
Chemistry · 17d
Cleared Jan 16, 1981
CHOLESTEROL REAGENT ENZYMATIC
K803287 · CHH
Rai, Inc.
Chemistry · 17d
Cleared Jan 16, 1981
ENDAB CHOLYLGLYCINE ENZYME IMMUNO. KIT
K803296 · KWW
Immunotech Corp.
Chemistry · 17d
Cleared Jan 16, 1981
LUQUIZYME TRIGLYCERIDE REAGENT SET
K803297 · CDT
Amresco, Inc.
Chemistry · 17d
Cleared Jan 16, 1981
CREATINE KINASE REAGENT
K803301 · CGS
Gilford Diagnostics
Chemistry · 17d
Cleared Jan 16, 1981
DUPONT 'ACA' CREATINE KINASE VERIFIERS
K803305 · JJT
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 17d
Cleared Jan 16, 1981
VITASTAT ECG-1/ECG-3 ELECTROCARDIOGRAPH
K803309 · DPS
Advanced Technology Laboratories, Inc.
Cardiovascular · 17d
Cleared Jan 16, 1981
'NO-BOIL' DUALCOUNT KIT
K810001 · CGN
Diagnostic Products Corp.
Chemistry · 10d
Cleared Jan 16, 1981
'NO-BOIL' VITAMIN B12 KIT
K810002 · CDD
Diagnostic Products Corp.
Chemistry · 10d
Cleared Jan 16, 1981
ALP-KII
K810008 · DXQ
Martin'S Maine Exchange
Cardiovascular · 11d
Cleared Jan 16, 1981
FETAL BLOOD SAMPLING KIT MODEL 1560
K810028 · HGW
Transidyne General Corp.
Obstetrics & Gynecology · 10d
Cleared Jan 15, 1981
CYTOTRAN I BONE MARROW ASPIRATION SYSTEM
K802406 · FMF
Applied Medical Devices, Inc.
General Hospital · 104d
Cleared Jan 15, 1981
MARK III ULTRASONIC SCANNING SYSTEM
K802437 · IYO
Advanced Technology Laboratories, Inc.
Radiology · 101d
Cleared Jan 15, 1981
GE RT/PLAN MAGNETIC TAPE DRIVE OPTION
K802801 · KPS
General Electric Co.
Radiology · 70d
Cleared Jan 15, 1981
SCANLAN VASCU-STATT
K802829 · FMP
Scanlan Intl., Inc.
General Hospital · 66d
Cleared Jan 15, 1981
L.A.F. ISOLATION PACK
K802885 · FYA
Action Medical Systems, Inc.
General Hospital · 59d
Cleared Jan 15, 1981
MULTI-IMAGE CAMERA-#627 TLC
K802905 · IYO
Dunn Systems, Inc.
Radiology · 59d
Cleared Jan 15, 1981
SUPER-SPIKE TRANSFER SET
K802940 · KSB
Geneva Laboratories, Inc.
Hematology · 57d
Cleared Jan 15, 1981
POSITIVE END EXPIRATORY PRESSURE VALVE
K802943 · BYE
Fraser Harlake, Inc.
Anesthesiology · 57d
Cleared Jan 15, 1981
DUAL-TROL
K802972 · GEI
Cimarron Instruments, Inc.
General & Plastic Surgery · 55d
Cleared Jan 15, 1981
BONE-DRI SURGICAL SPONGE
K803125 · NAB
Howmedica Corp.
General & Plastic Surgery · 34d
Cleared Jan 15, 1981
LKB-WALLACE 1250 LUMINOMETER
K803131 · JJQ
Lkb Instruments, Inc.
Hematology · 34d