FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
153385–153408 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Mar 23, 1984
CHOLESTEROL AQUEOUS STANDARD
K840217 · JIS
Preventive Diagnostics Corp.
Chemistry · 64d
Cleared Mar 23, 1984
TRIGLYCERIDE AQUEOUS STANDARDS
K840218 · JIT
Preventive Diagnostics Corp.
Chemistry · 64d
Cleared Mar 23, 1984
TRIGLYCERIDE/CHOLESTEROL AQUEOUS
K840219 · JIX
Preventive Diagnostics Corp.
Chemistry · 64d
Cleared Mar 23, 1984
HDL CHOLESTEROL AQUEOUS STANDARDS
K840220 · JIS
Preventive Diagnostics Corp.
Chemistry · 64d
Cleared Mar 23, 1984
UROLIX-3 UROLOGICAL TABLE
K840227 · IXR
Medicor USA , Ltd.
Radiology · 64d
Cleared Mar 23, 1984
FSH QUIK RIA KIT
K840230 · CGJ
Pacific Biotech, Inc.
Chemistry · 63d