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
167737–167760 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 08, 1980
SEARS ALL-IN-THE-EAR HEARING AID #8149
K800446 · ESD
Int'L Hearing Aids, Inc.
Ear, Nose, Throat · 40d
Cleared Apr 08, 1980
SEARS ALL-IN-THE-EAR HEARING AID #8149HF
K800447 · ESD
Int'L Hearing Aids, Inc.
Ear, Nose, Throat · 40d
Cleared Apr 08, 1980
SUR-FIT UROSTOMY POUCH & URINARY BAG
K800495 · EXB
E. R. Squibb & Sons, Inc.
Gastroenterology & Urology · 35d
Cleared Apr 08, 1980
PULSEOMETER
K800500 · DRT
Kirklands Sporting Goods Co.
Cardiovascular · 35d
Cleared Apr 08, 1980
URETHRAL CATHETER
K800505 · KOD
Medi-Craft , Ltd.
Gastroenterology & Urology · 35d
Cleared Apr 08, 1980
FEEDING TUBES
K800507 · KNT
Medi-Craft , Ltd.
Gastroenterology & Urology · 35d
Cleared Apr 08, 1980
STOMACH TUBES
K800508 · KNT
Medi-Craft , Ltd.
Gastroenterology & Urology · 35d
Cleared Apr 08, 1980
RECTAL & HARRIS FLUSH TUBES
K800510 · KNT
Medi-Craft , Ltd.
Gastroenterology & Urology · 35d
Cleared Apr 08, 1980
MEDICAL COMPONENTS IV CATHETER
K800525 · FOZ
Medical Components, Inc.
General Hospital · 32d
Cleared Apr 08, 1980
DISP. HYDROGEN & CO2 GENERATOR ENVELOPE
K800539 · KZJ
Bd Becton Dickinson Vacutainer...
Microbiology · 29d
Cleared Apr 08, 1980
CAMBRIDGE VS-550 ELECTROCARDIOGRAPH
K800566 · DPS
Cambridge Instruments, Inc.
Cardiovascular · 26d
Cleared Apr 08, 1980
SYRINGE INFUSION PUMP #2720
K800569 · FRN
Harvard Apparatus, Inc.
General Hospital · 25d
Cleared Apr 08, 1980
BETA-ASE TUBES
K800579 · JTO
Microchemical Specialities, Co.
Microbiology · 25d
Cleared Apr 08, 1980
SUPRAPUBIC TROCAR
K800607 · KOB
G.D. Searle and Co.
Gastroenterology & Urology · 22d
Cleared Apr 08, 1980
STONE DISLODGER
K800608 · FFL
G.D. Searle and Co.
Gastroenterology & Urology · 22d
Cleared Apr 08, 1980
URETHRAL SOUND
K800610 · KOE
G.D. Searle and Co.
Gastroenterology & Urology · 22d
Cleared Apr 08, 1980
BOUGIE A BOULE
K800611 · KOE
G.D. Searle and Co.
Gastroenterology & Urology · 22d
Cleared Apr 08, 1980
ANGIOPLASTY INJECTOR
K800613 · DXT
Medrad, Inc.
Cardiovascular · 21d
Cleared Apr 08, 1980
CYBERLITH IMPLANTABLE PULSE GEN. #253-04
K800645 · DXY
Intermedics, Inc.
Cardiovascular · 15d
Cleared Apr 08, 1980
SCHILLER MSG-1
K800659 · DPS
Renesco International, Inc.
Cardiovascular · 13d
Cleared Apr 08, 1980
MODEL S/D-600 AUTO INFLATE CONTROL MODUL
K800661 · DXN
Applied Science Laboratories
Cardiovascular · 13d
Cleared Apr 08, 1980
MARK II
K800662 · DXN
Applied Science Laboratories
Cardiovascular · 13d
Cleared Apr 08, 1980
MARK III
K800663 · DXN
Applied Science Laboratories
Cardiovascular · 13d
Cleared Apr 08, 1980
MODIFIED CATHETER PACKAGE
K800703 · DQO
Hancock Laboratories, Inc.
Cardiovascular · 12d