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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
147337–147360 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 16, 1985
CR26, CR26A, CR26B, CR26C(CARDIAC DC DEFIBRILLATO)
K852808 · LDD
Cardiac Recorders, Ltd.
Cardiovascular · 76d
Cleared Sep 16, 1985
IMPLANTABLE ELECTRODE LEAD, MODEL 030-400
K852972 · DTB
Telectronics, Inc.
Cardiovascular · 63d
Cleared Sep 16, 1985
MICROMEDIC COMBOSTAT B B12/FOLATE(BOIL)
K853127 · CDD
Micromedic Systems
Chemistry · 53d
Cleared Sep 16, 1985
PROXIMAL POROCOAT MODIFIED MEDICAL ASPECT AML HIP
K853205
Depuy, Inc.
Orthopedic · 47d
Cleared Sep 16, 1985
ACCU-FLO PRESSURE VALVE
K853215 · JXG
Codman & Shurtleff, Inc.
Neurology · 46d
Cleared Sep 16, 1985
PRECEPT CEFTRIAXONE
K853273 · LTW
Austin Biological Laboratories
Microbiology · 42d
Cleared Sep 16, 1985
GILFORD IMMUNOGLOBULIN G REAGENT
K853465 · DEW
Gilford
Immunology · 28d
Cleared Sep 16, 1985
GILFORD C3 COMPLEMENT REAGENT
K853466 · CZW
Gilford
Immunology · 28d
Cleared Sep 16, 1985
GILFORD IMMUNOGLOBULIN A REAGENT
K853467 · CZP
Gilford
Immunology · 28d
Cleared Sep 16, 1985
GILFORD C4 COMPLEMENT REAGENT
K853468 · DBI
Gilford
Immunology · 28d
Cleared Sep 16, 1985
GILFORD IMMUNOGLOBULIN M REAGENT
K853469 · DFT
Gilford
Immunology · 28d
Cleared Sep 16, 1985
ALCOHOL CALIBRATORS
K853532 · DNN
Diagnostic Systems
Chemistry · 24d
Cleared Sep 16, 1985
ABSORBANCE TEST SOLUTION
K853533 · JIT
Diagnostic Systems
Chemistry · 24d
Cleared Sep 16, 1985
STRATUS N-ACETYLPROCAINAMIDE FLUOROMETRIC ENZYME I
K853547 · LAN
American Dade
Chemistry · 21d
Cleared Sep 16, 1985
DIASCAN CONTROL
K853553 · JJX
Home Diagnostics, Inc.
Chemistry · 21d
Cleared Sep 16, 1985
MODERN MEDICAL PRODUCTS TOWEL CLAMP
K853583 · GDJ
Modern Medical Products
General & Plastic Surgery · 21d
Cleared Sep 16, 1985
MAGNESIUM
K853592 · JGJ
Pointe Scientific, Inc.,
Chemistry · 20d
Cleared Sep 16, 1985
PRECEPT CEFOPERAZONE
K853596 · LTW
Austin Biological Laboratories
Microbiology · 20d
Cleared Sep 16, 1985
MORGAN ARTHROSCOPIC MENESUS & SYNOVIAL RASP
K853601 · GAC
Bowen & Company, Inc.
General & Plastic Surgery · 20d
Cleared Sep 16, 1985
APL MOTILITY INDOLE ORNITHINE AGAR
K853610 · JSH
Apl Medical Supplies
Microbiology · 18d
Cleared Sep 16, 1985
APL SIMMONS CITRATE AGAR
K853617 · JSI
Apl Medical Supplies
Microbiology · 18d
Cleared Sep 16, 1985
APL SIM MEDIUM
K853618 · JSH
Apl Medical Supplies
Microbiology · 18d
Cleared Sep 16, 1985
APL TRIPLE SUGAR IRON AGAR
K853619 · JSH
Apl Medical Supplies
Microbiology · 18d
Cleared Sep 16, 1985
CORNING CELL WELLS-MULTIPLE WELL PLATES
K853634 · KIZ
Corning Medical & Scientific
Pathology · 17d