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
154225–154248 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 26, 1984
CHOCOLATE AGAR W/COFACTOR
K841144 · JSG
Anaerobe Systems
Microbiology · 10d
Cleared Mar 26, 1984
COMPRESSION STOCKINGS W/WAIST SUSPENS-
K841253
Baurs Krey Assoc., Inc.
General Hospital
Cleared Mar 26, 1984
CSPI ROTARY SURGICAL ASPIRATOR
K841383
Custom Surgical Products, Inc.
Cardiovascular
Cleared Mar 23, 1984
TOBRAMYCIN REAGENT
K832763 · KLB
Biosan Laboratories, Inc.
Chemistry · 220d
Cleared Mar 23, 1984
ACE COLOR TEST
K833933 · KQN
Hana Biologics, Inc.
Chemistry · 130d
Cleared Mar 23, 1984
ERYTHROPOIETIN EIA
K833957 · GGT
Jcl Clinical Research Corp.
Hematology · 128d
Cleared Mar 23, 1984
ORTHO BI-LEVEL RECEPTOR CONTROL
K834064 · JJY
Ortho Diagnostic Systems, Inc.
Chemistry · 119d
Cleared Mar 23, 1984
IMMPULSE SYSTEM
K834070 · JZT
Paragon Diagnostics, Inc.
Immunology · 119d
Cleared Mar 23, 1984
TISSUE CULTURE REFEEDING MEDIUM
K834113 · KIT
Bartels Immunodiagnostic Supplies, Inc.
Pathology · 115d
Cleared Mar 23, 1984
CULTROL-ANTIBIOTIC/ANTIMYCOTIC SOLUT
K834115 · JSK
Bartels Immunodiagnostic Supplies, Inc.
Microbiology · 115d
Cleared Mar 23, 1984
COLLOID OSMOMETER 4400
K834208 · JJM
Wescor, Inc.
Chemistry · 109d
Cleared Mar 23, 1984
PBC SYRINGE IRRIGATING
K834256 · FMF
Philadelphia Biologics Center
General Hospital · 107d
Cleared Mar 23, 1984
ECHO MM1000
K834447 · LIF
Mesa Medical, Inc.
Gastroenterology & Urology · 98d
Cleared Mar 23, 1984
KINETIC LDH, A< BLUE 610 METHOD
K840006 · CFJ
American Monitor Corp.
Chemistry · 79d
Cleared Mar 23, 1984
DPC ACTH KIT
K840018 · CKG
Diagnostic Products Corp.
Chemistry · 78d
Cleared Mar 23, 1984
COAT-A-COUNT ESTRADIOL KIT
K840051 · CHP
Diagnostic Products Corp.
Chemistry · 77d
Cleared Mar 23, 1984
ADVANTAGE
K840120 · JJE
Gilford
Chemistry · 72d
Cleared Mar 23, 1984
UNI-FAST ANALYZER SYSTEM
K840129 · JJE
Sclavo, Inc.
Chemistry · 72d
Cleared Mar 23, 1984
CRISA
K840135 · ITY
X-Ray Tube Corp.
Radiology · 80d
Cleared Mar 23, 1984
PROTECTA COAT SPONGES
K840156 · IZZ
Alimed, Inc.
Radiology · 70d
Cleared Mar 23, 1984
IMMOPHASE DTESTO RADIOIMMUNOASSAY-
K840187 · CDZ
Corning Medical & Scientific
Chemistry · 65d
Cleared Mar 23, 1984
MICROMEDIC LH & FSH RIA KIT
K840188 · CEP
Micromedic Systems
Chemistry · 65d
Cleared Mar 23, 1984
TOTAL CHOLESTEROL REAGENT SET
K840189 · CHH
Preventive Diagnostics Corp.
Chemistry · 65d
Cleared Mar 23, 1984
EMIT QST AMIKACIN ASSAY
K840193 · KLQ
Syva Co.
Toxicology · 65d