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
162433–162456 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 29, 1981
RHESUS MONKEY BLOOD IN ALSEVER'S
K813512 · LHW
Dutchland Laboratories, Inc.
Pathology · 14d
Cleared Dec 29, 1981
EDSLAB CATHETER COVER
K813514 · DQY
American Edwards Laboratories
Cardiovascular · 14d
Cleared Dec 29, 1981
MRI TOBRAMYCIN RIA KIT
K813516 · KLB
Microanalytic Research, Inc.
Microbiology · 14d
Cleared Dec 22, 1981
AGGLUTEX METHAQUALONE TEST KIT
K812987 · KXS
Hoffmann-La Roche, Inc.
Toxicology · 57d
Cleared Dec 22, 1981
SHARIA-LH RIA KIT FOR QUANTITATION HORMO
K813213 · CEP
Intl. Immunoassay Laboratories, Inc.
Chemistry · 43d
Cleared Dec 22, 1981
TROCKI BODY VENTRILATOR
K813326 · BYT
L.T.D. 3 Co.
Anesthesiology · 28d
Cleared Dec 22, 1981
BI-LEVEL ACETAMINOPHEN-SALICYLATE CNRL
K813349 · DIF
Stanbio Laboratory
Microbiology · 25d
Cleared Dec 22, 1981
AMMONIA TEST
K813366 · JID
Wako Pure Chemical Industries, Ltd.
Chemistry · 22d
Cleared Dec 22, 1981
GRAM STAIN REAGENTS AND KIT
K813369 · JTS
Bd Becton Dickinson Vacutainer...
Hematology · 22d
Cleared Dec 22, 1981
ELECTROLYTE GEL
K813370 · CGA
Hi Chem, Inc.
Chemistry · 22d
Cleared Dec 22, 1981
VYGON ENDOTRACHEAL TUBES
K813373 · BTR
Exco, Inc.
Anesthesiology · 21d
Cleared Dec 22, 1981
RADIOIMMUNOASSAY FOR HUMAN THYROID
K813392 · JLW
Leeco Diagnostics, Inc.
Chemistry · 19d
Cleared Dec 22, 1981
INORGANIC PHOSPHORUS REAGENT SET
K813400 · CEO
Anco Medical Reagents & Assoc.
Pathology · 18d
Cleared Dec 22, 1981
COAT-A-COUNT TESTOSTERONE RIA KIT
K813401 · CDZ
Diagnostic Products Corp.
Chemistry · 18d
Cleared Dec 22, 1981
AST(SGOT) IN VITRO DIAG. REAGENT SET
K813405 · CIT
Pointe Scientific, Inc.,
Chemistry · 15d
Cleared Dec 22, 1981
CPK(CK) IN VITRO DIAG. REAGENT SET
K813406 · JHS
Pointe Scientific, Inc.,
Chemistry · 15d
Cleared Dec 22, 1981
MULTIWASH
K813426 · JQW
Flow Laboratories, Inc.
Chemistry · 15d
Cleared Dec 22, 1981
TRIGLYCERIDE CALIBRATORS
K813478 · JIS
Gilford Diagnostics
Chemistry · 21d
Cleared Dec 22, 1981
PROGESTERONE KIT BY RIA
K813484 · JLS
Immuchem Corp.
Chemistry · 21d
Cleared Dec 18, 1981
FLAT DRAIN
K813063 · GBW
Sil-Med Corp.
General & Plastic Surgery · 49d
Cleared Dec 18, 1981
CONTURA DISPOS. SURG. FACE MASK
K813078 · FXX
American Convertors Div., American...
General Hospital · 46d
Cleared Dec 18, 1981
OXYGEN CONNECTING TUBE
K813197 · BYX
Northern Medical Industries
Anesthesiology · 35d
Cleared Dec 18, 1981
BOUNDARY DRAPE TAPE
K813277 · KKX
The Buckeye Cellulose Corp.
General Hospital · 25d
Cleared Dec 18, 1981
VPI URETERAL DILATATION BALLON CATHETER
K813278 · EZN
Vance Products, Inc.
Gastroenterology & Urology · 25d