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
164953–164976 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 13, 1981
DOUBLE LUMEN TRACHEAL TUBE
K802505 · BTR
National Catheter Co. Div. Mallinckrodt
Anesthesiology · 149d
Cleared Mar 13, 1981
KPP PERITONEAL DIALYSATE FILTER
K803275 · KPP
Millipore Corp.
Gastroenterology & Urology · 74d
Cleared Mar 13, 1981
MIROMED PERITONEAL DIALYSIS CATHETER
K810236 · FJS
American Medical Products, Inc.
Gastroenterology & Urology · 45d
Cleared Mar 13, 1981
VESSEL TIPS, SIZES 13-18
K810257 · FKW
Quinton, Inc.
Gastroenterology & Urology · 42d
Cleared Mar 13, 1981
DATASON DB ULTRASOUND IMAGING SYSTEM
K810305 · HEM
General Electric Co.
Obstetrics & Gynecology · 36d
Cleared Mar 13, 1981
TEMPORARY MYOCARDIAL PACING LEAD#6400
K810333 · DTB
Medtronic Vascular
Cardiovascular · 32d
Cleared Mar 13, 1981
ELECTROENCEPHALOMYOGRAPH
K810359 · OLT
Thoracel Research Labs.
Neurology · 31d
Cleared Mar 13, 1981
CORRUGATED FLEX TUBING #6000,
K810374 · BYX
Todd Industries, Inc.
Anesthesiology · 29d
Cleared Mar 13, 1981
THINLITH II PULSE GNEERATOR MODEL 227-05
K810386 · DXY
Intermedics, Inc.
Cardiovascular · 28d
Cleared Mar 13, 1981
VICRYL
K810428 · FTL
Ethicon, Inc.
General & Plastic Surgery · 23d
Cleared Mar 13, 1981
VENTURI MASK/DELIVERY SYSTEM #6078
K810430 · BYF
Todd Industries, Inc.
Anesthesiology · 22d
Cleared Mar 13, 1981
CORDIS PERVENOUS ATRIAL LEAD
K810432 · DTB
Cordis Corp.
Cardiovascular · 22d
Cleared Mar 13, 1981
LOWER EXTREMITY SUPPORT SYSTEM-LESS
K810433 · FWZ
Walgen Medical Innoventions
General & Plastic Surgery · 22d
Cleared Mar 13, 1981
SCANLAN SUTURE BOOTS
K810480 · KOC
Scanlan Intl., Inc.
Hematology · 18d
Cleared Mar 13, 1981
GOMCO SUCTION PUMP CABINET CHANGE
K810490 · BTA
Allied Healthcare Products, Inc.
General & Plastic Surgery · 17d
Cleared Mar 13, 1981
VERI/PMS MODEL 815
K810496 · IPF
Verite
Physical Medicine · 17d
Cleared Mar 13, 1981
MEDISEAL CAMERA COVERS
K810512 · KQM
Janin Group, Inc.
General & Plastic Surgery · 17d
Cleared Mar 13, 1981
MOURADIAN MODIFIED ZICKEL HUMERAL ROD
K810535 · HSB
Howmedica Corp.
Orthopedic · 15d
Cleared Mar 13, 1981
CEMENT FUME EVACUATOR TANK & FILTER
K810542 · JDY
Walgen Medical Innoventions
Orthopedic · 14d
Cleared Mar 13, 1981
LUMBAR FLEXION BRACE
K810554 · IPY
Orthomedics
Physical Medicine · 11d
Cleared Mar 13, 1981
SCOLIOSIS ORTHOTIC SYSTEM
K810555 · IQF
Orthomedics
Physical Medicine · 11d
Cleared Mar 13, 1981
SPINAL EXTENSION BRACE
K810556 · IPY
Orthomedics
Physical Medicine · 11d
Cleared Mar 13, 1981
HIP ABDUCTION SPLINT
K810557 · IOZ
Orthomedics
Physical Medicine · 11d
Cleared Mar 13, 1981
GERMCO TEST R GLUCOSE TEST KIT
K810567 · CGA
Fermco Biochemics, Inc.
Chemistry · 10d