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
157177–157200 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 05, 1983
PHASE II DIGOXIN RADIOIMMUNOASSAY KIT
K830533 · DON
Medical & Scientific Designs, Inc.
Chemistry · 46d
Cleared Apr 05, 1983
CORNING 2500 CO-OXIMETER
K830590 · KHG
Corning Medical & Scientific
Hematology · 40d
Cleared Apr 05, 1983
ACTIVATED URIC ACID
K830616 · CHD
American Monitor Corp.
Chemistry · 36d
Cleared Apr 05, 1983
FLUOROMETER, GENERAL USE
K830624 · KHO
Abbott Diagnostics
Toxicology · 36d
Cleared Apr 05, 1983
POTASSIUM DILUENT
K830636 · JIH
Shaban Mfg. Co.
Toxicology · 35d
Cleared Apr 05, 1983
ENCORE CHEMISTRY ANALYZER
K830641 · JJG
Baker Instructions Corp.
Chemistry · 35d
Cleared Apr 05, 1983
PHASE THYROXINE RADIOIMMUNOASSAY KIT
K830642 · CDX
Medical & Scientific Designs, Inc.
Chemistry · 35d
Cleared Apr 05, 1983
FIAX COMPLEMENT C3 TEST KIT
K830668 · CZW
Intl. Diagnostic Technology
Immunology · 32d
Cleared Apr 05, 1983
CREATINE KINASE REAGENT SET
K830672 · JHY
Sterling Biochemical, Inc.
Chemistry · 32d
Cleared Apr 05, 1983
DUPONT PREP OD EXTRACTION CARTRIDE
K830692 · DJY
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 29d
Cleared Apr 05, 1983
DUPONT PREP TYPE AS EXTRACTION CARTRIDE
K830693 · DJY
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 29d
Cleared Apr 05, 1983
CARDIOTOMY RESERVOIR-FILTERED & NON
K830727 · DTP
Electromics, Inc.
Cardiovascular · 28d
Cleared Apr 05, 1983
FEKAL CON-TRATE SYSTEM
K830769 · KLI
Trend Scientific, Inc.
Chemistry · 25d
Cleared Apr 05, 1983
STERILE SURGICAL PAIN RELIEF ELECTRODE
K830798 · GXY
Lectec Corp.
Neurology · 22d
Cleared Apr 05, 1983
OB HELP ARM
K830842 · ILE
Lic-Orthion
Physical Medicine · 19d
Cleared Apr 05, 1983
RESI-WALKER
K830848 · ITJ
Lic-Orthion
Physical Medicine · 19d
Cleared Apr 05, 1983
OB TILT
K830849 · INQ
Lic-Orthion
Physical Medicine · 19d
Cleared Apr 05, 1983
OB TRIPP TRANSPORT CHAIR
K830850 · INM
Lic-Orthion
Physical Medicine · 19d
Cleared Apr 05, 1983
BATH TUB SEAT & BATH BOARD
K830851 · ILC
Lic-Orthion
Physical Medicine · 19d
Cleared Apr 05, 1983
SHOWER STOOL W/HANDLES
K830852 · ILS
Lic-Orthion
Physical Medicine · 19d
Cleared Apr 05, 1983
COLLAPSABLE LAVATORY SEAT HEIGHTENER
K830854 · ILC
Lic-Orthion
Physical Medicine · 19d
Cleared Apr 05, 1983
SESAM TREATMENT TABLE
K830855 · INQ
Lic-Orthion
Physical Medicine · 19d
Cleared Apr 05, 1983
MANOMETER SET C.V.P. #S 298/299
K830910 · KRK
Exco, Inc.
Cardiovascular · 15d
Cleared Apr 04, 1983
NOVO BMC LAB 22A BONE MINERAL CONTENT DETERMINATION IN THE AXIAL SKELETON
K828574
Novo Diagnostic Systems
Radiology · 35d