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
165649–165672 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 30, 1980
HELENA HEMESPEC II TOTAL HEMOGLOBIN MET.
K803016 · GKR
Helena Laboratories
Hematology · 32d
Cleared Dec 30, 1980
PROXIMATE*II DISPOSABLE SKIN STAPLER
K803038 · GAG
Ethicon, Inc.
General & Plastic Surgery · 29d
Cleared Dec 30, 1980
SERUM FREE TISSUE CULTURE MEDIA
K803041 · KIT
Cartaya Assoc.
Pathology · 29d
Cleared Dec 30, 1980
SPRAY, SYNTHETIC SMEAR
K803050 · IFI
Laboratory Products, Inc.
Pathology · 28d
Cleared Dec 30, 1980
HIGH FREQUENCY AUDIOMETER DELMAR #20-K
K803072 · EWO
Demlar Medical, Inc.
Ear, Nose, Throat · 25d
Cleared Dec 30, 1980
MENTOR 402 TRANSCUTANEOUS ELEC. STIMULAT
K803113 · GZJ
George H. Frisch
Neurology · 20d
Cleared Dec 30, 1980
LARGE WOUND DRESSING KIT
K803119 · KDD
American Medical Disposable, Inc.
General & Plastic Surgery · 20d
Cleared Dec 30, 1980
MENTOR 150 TRANSCUTANEOUS NERVE STIMULA
K803121 · GZJ
George H. Frisch
Neurology · 19d
Cleared Dec 30, 1980
ECG & ULTRASOUND GELS, CREAMS & LOTION
K803151 · GYB
Abco Dealers, Inc.
Neurology · 18d
Cleared Dec 30, 1980
CONPHAR PERCUSSION HAMMER(BUCK TYPE)
K803174 · GWZ
Conphar, Inc.
Neurology · 15d
Cleared Dec 23, 1980
CUSTOM DRESSING TRAY WET TO DRY
K803117 · KDD
American Medical Disposable, Inc.
General & Plastic Surgery · 13d
Cleared Dec 22, 1980
BELLCO SINGLE NEEDLE DOUBLE HEAD PUMP
K802230 · FIF
Cardio Med Supplies, Inc.
Gastroenterology & Urology · 97d
Cleared Dec 22, 1980
INTRAJECT
K802332 · KYG
General Medical Engineering Corp.
Ophthalmic · 90d
Cleared Dec 22, 1980
MICRO THIN-DII, #0521
K802352 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 88d
Cleared Dec 22, 1980
MICRO THIN-PII, #0523
K802353 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 88d
Cleared Dec 22, 1980
GAMBRO LUNDIA PLATE DISP. DIALYZER
K802389 · FJG
Gambro, Inc.
Gastroenterology & Urology · 84d
Cleared Dec 22, 1980
KERATOPLASTY SUTURING LENS
K802593 · HPX
Paris Contact Lens Laboratory
Ophthalmic · 62d
Cleared Dec 22, 1980
EMERG. OXYGEN KIT #65350 & #65399 CASE
K802644 · CAN
B & F Medical Products, Inc.
Anesthesiology · 59d
Cleared Dec 22, 1980
PRO-OPHTA STICKS
K802794 · HOZ
Secol Co.
Ophthalmic · 48d
Cleared Dec 22, 1980
CORNING NORMAL GLYCOSYLATED HEMOGLOBIN
K802884 · JBD
Corning Medical & Scientific
Hematology · 35d
Cleared Dec 22, 1980
COBE CENTRY 2 VARIABLE CONCENTRATE-18-
K802895 · KDC
Cobe Laboratories, Inc.
General & Plastic Surgery · 35d
Cleared Dec 22, 1980
PLASTIC FRACTURE CAST BRACE KNEE JOINT
K802910 · IQI
Orthomedics
Physical Medicine · 35d
Cleared Dec 22, 1980
HELENA AT-III QUIPLATE PROCEDURE
K802912 · JBQ
Helena Laboratories
Hematology · 34d
Cleared Dec 22, 1980
QUANTIMUNE E3 RIA
K802944 · CGI
Bio-Rad
Toxicology · 33d