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
146353–146376 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 13, 1985
KEELER AMOILS SURGICAL ASTIGOMETER
K854256
Keeler Instruments, Inc.
Ophthalmic · 52d
Cleared Dec 13, 1985
CLIRANS TAF HOLLOW FIBER DIALYZER
K854280 · FJI
Terumo Medical Corp.
Gastroenterology & Urology · 51d
Cleared Dec 13, 1985
GAMBRO BLOOD CONCENTRATOR SETS 16,60,200
K854309 · KDI
Gambro, Inc.
Gastroenterology & Urology · 49d
Cleared Dec 13, 1985
IS-2000 DIGITAL OPHTHALMIC IMAGING SYSTEM
K854330 · HKI
Par Technology Park
Ophthalmic · 46d
Cleared Dec 13, 1985
RAICHEM CO2 REAGENT
K854544 · KHS
Reagents Applications, Inc.
Chemistry · 30d
Cleared Dec 13, 1985
CONVEEN SELF-SEALING URISHEATH MALE EXTERNAL CATH
K854580 · KNX
Coloplast A/S
Gastroenterology & Urology · 28d
Cleared Dec 13, 1985
HOLLOW FIBER DIALYZER
K854586 · KDI
Travenol Laboratories, S.A.
Gastroenterology & Urology · 25d
Cleared Dec 13, 1985
DSL PROGESTERONE RIA (DSL #3400)
K854649 · JLS
Diagnostic Systems Laboratories, Inc.
Chemistry · 24d
Cleared Dec 13, 1985
DSL ACTIVE ANDROSTENEDIONE RIA (DSL #3800)
K854650 · CIZ
Diagnostic Systems Laboratories, Inc.
Chemistry · 24d
Cleared Dec 13, 1985
PARAAMAX CHLORIDE DETERMINATION BY ISE
K854651 · CGJ
American Dade
Chemistry · 24d
Cleared Dec 13, 1985
CEKK-ADHESIVE MATRIX-MULTIPLE WELL PLATE CAM-PLATE
K854724 · KIZ
Lifetrac, Inc.
Pathology · 21d
Cleared Dec 13, 1985
EVEREST & JENNINGS BED MODEL NO. L109564 & L108564
K854776 · FNJ
Carrom Healthcare, Inc.
General Hospital · 14d
Cleared Dec 12, 1985
ANTI-EPSTEIN-BARR VIRUS KIT
K842662 · GNP
Amico Lab, Inc.
Immunology · 520d
Cleared Dec 12, 1985
NIFA NON INVASIVE FLUTTER ASSEMBLY
K844853 · KDQ
Emergency Management Products, Inc.
General Hospital · 363d
Cleared Dec 12, 1985
L.E.D. GOGGLES, MODEL 580-LEDGOG
K852533 · GWE
Bio-Logic Systems Corp.
Neurology · 181d
Cleared Dec 11, 1985
PRESSURE TRIGGER MOD OF SMEC INTRA-AORT
K840367 · DSP
Smec, Inc.
Cardiovascular · 684d
Cleared Dec 11, 1985
CARDIORATER CR 51
K853673 · DRT
Cardiac Recorders, Ltd.
Cardiovascular · 98d
Cleared Dec 11, 1985
ARTERIAL/VENOUS SAMPLE LINE BOS-CMSL
K853950 · DTL
American Bentley
Cardiovascular · 77d
Cleared Dec 11, 1985
PALL EC PLUS 3LPM MAX. FILTER W/SLEEVE
K853987 · DTM
Pall Biomedical Products Co.
Cardiovascular · 75d
Cleared Dec 11, 1985
MGA 2000 GAS ANALYSER
K854076 · DOP
Airspec , Ltd.
Toxicology · 65d
Cleared Dec 11, 1985
KALLESTAD QUANTIMETRIC PLUS IGG REAGENT KIT
K854483 · KTO
Kallestad Laboratories, Inc.
Immunology · 34d
Cleared Dec 11, 1985
DELTA-LITE CASTING RESIN
K854554 · LGF
Johnson & Johnson Professionals, Inc.
Orthopedic · 28d
Cleared Dec 11, 1985
EMERSON MODEL 3MV-OAA ALARM MODULE
K854799 · CCL
J. H. Emerson Co.
Anesthesiology · 9d
Cleared Dec 10, 1985
MEDAJET XL - JET INJECTOR
K850754 · KZE
Mada Medical Products, Inc.
General Hospital · 288d