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
166369–166392 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 10, 1980
TORQUE CONTROL BALLOON CATHETER
K802338 · DYG
Cordis Corp.
Cardiovascular · 14d
Cleared Oct 10, 1980
SPECIMEN SET
K802340 · FMH
American Pharmaseal Div. Ahsc
General Hospital · 14d
Cleared Oct 10, 1980
PREGNA B-ANTI HUMAN CHORIONIC GONADOTRO
K802343 · JHJ
Intl. Diagnostic, Inc.
Chemistry · 14d
Cleared Oct 10, 1980
OREIA-Q-DIG
K802358 · KXT
Organon, Inc.
Toxicology · 14d
Cleared Oct 10, 1980
ALGINATE IMPRESSION MATERIAL
K802362 · ELW
Dentsply Intl.
Dental · 14d
Cleared Oct 10, 1980
NU-BORN BABY BATH KIT
K802366 · LDQ
American Hospital Supply Corp.
General & Plastic Surgery · 11d
Cleared Oct 10, 1980
AMPCO SKIN SCRUB TRAY
K802375 · FMC
Associated Medical Products Co.
General Hospital · 10d
Cleared Oct 10, 1980
QUICK PRIME LINES, #'S BPL-12, BPL-48 &
K802378 · DWF
Bentley Laboratories, Inc.
Cardiovascular · 10d
Cleared Oct 06, 1980
HYCEL TRIGYCERIDE II TEST
K802422
Hycel, Inc.
Chemistry
Cleared Oct 03, 1980
DOUCHE TRAY-DISPOS. VAGINAL TRAY W/POVID
K800954 · HED
The Healthcare Group Laboratories, Inc.
Obstetrics & Gynecology · 163d
Cleared Oct 03, 1980
DOUCH TRAY-DISPOSABLE VAGINAL TRAY W/BEN
K800956 · HED
The Healthcare Group Laboratories, Inc.
Obstetrics & Gynecology · 163d
Cleared Oct 03, 1980
OXFORD HUMAN MILK PASTEURISER
K801246 · HGX
Vickers America Medical Corp.
Obstetrics & Gynecology · 128d
Cleared Oct 03, 1980
F/LS MCA APPLICATION SOFTWARE
K801456 · CFR
Instrumentation Laboratory CO
Immunology · 101d
Cleared Oct 03, 1980
INFANT VENTILATORY MEASUREMENT SYSTEM
K801497 · BZC
Medical Graphics Corp.
Anesthesiology · 99d
Cleared Oct 03, 1980
HESSBURG-BFRRON TREPHINE
K801585 · EMF
Precision Instruments, Inc.
General & Plastic Surgery · 84d
Cleared Oct 03, 1980
POLYETHYLENE FILLED BONE PLATE
K801603 · HRS
Zimmer, Inc.
Orthopedic · 81d
Cleared Oct 03, 1980
SORIN PULSE GENERATOR, MODEL #LIT-214
K801640 · DXY
Bentley Laboratories, Inc.
Cardiovascular · 78d
Cleared Oct 03, 1980
BETA-CAP II
K801679 · FJS
Quinton, Inc.
Gastroenterology & Urology · 73d
Cleared Oct 03, 1980
SONIA-SO NOGRAPH-NUMERICAL ANALYSIS
K801844 · IYO
Cgr Medical Corp.
Radiology · 63d
Cleared Oct 03, 1980
SYSTEM 82 COMPUTERIZED LUNG VO. SPIRO
K801918 · BZC
Pulmonary Testing Systems
Anesthesiology · 53d
Cleared Oct 03, 1980
SYSTEM 88 COMPUTERIZED DIFFUSION ANALY
K801919 · BZC
Pulmonary Testing Systems
Anesthesiology · 53d
Cleared Oct 03, 1980
SYSTEM 80 COMPUTERIZED SPIROMETER
K801920 · BZC
Pulmonary Testing Systems
Anesthesiology · 53d
Cleared Oct 03, 1980
CABANNA TAN SUNLAMP
K801925 · LEJ
The Marketing Exchange, Inc.
Radiology · 52d
Cleared Oct 03, 1980
BCM-302 COLLIMATING CONE & COMPENSATIN
K801949 · JZW
B C Medical , Ltd.
Radiology · 49d