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
145921–145944 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 27, 1985
NYSTAGMOGRAPH EOG/ENG ANALYSES
K851190 · GWN
Nicolet Biomedical Instruments
Neurology · 246d
Cleared Nov 27, 1985
HEYER-SCHULTE SYRINGO PERITONEAL SHUNT
K854049 · JXG
American V. Mueller
Neurology · 55d
Cleared Nov 27, 1985
EXTERNAL VENTRICULAR DRAINAGE/MONITORING/LUMBAR SE
K854474 · JXG
Cordis Corp.
Neurology · 20d
Cleared Nov 27, 1985
VICKERS MEDICAL MODEL 273 OXYGEN MONITOR
K854599 · CCL
Vickers , Ltd.
Anesthesiology · 9d
Cleared Nov 26, 1985
IMMUNOPER-OXIDASE TEST KIT FOR DETECT OF
K842830 · GQN
Bartels Immunodiagnostic Supplies, Inc.
Microbiology · 494d
Cleared Nov 26, 1985
KEY MED TRANSENDOSCOPIC VASCULAR DETECTOR TVD-1
K851149 · JAF
Keymed, Inc.
Radiology · 250d
Cleared Nov 26, 1985
TWEETHEART #102 FETAL/NEONATAL HEARTBEAT ANNUNCIAT
K852704 · HGM
Clincal Instruments Corp.
Obstetrics & Gynecology · 153d
Cleared Nov 26, 1985
PATHFINDER DIRECT ANTIGEN DETECTION SYS ROTAVIRUS
K853554 · LIQ
Kallestad Laboratories, Inc.
Microbiology · 92d
Cleared Nov 26, 1985
SYS*STIM 207 MODEL ME 207
K853750 · IPF
Mettler Electronics Corp.
Physical Medicine · 78d
Cleared Nov 26, 1985
ACOUSTICALLY-COUPLED ELECTRONIC PHANTOM 84-410
K853755 · ITX
Victoreen, Inc.
Radiology · 78d
Cleared Nov 26, 1985
PORT-GARD
K854019 · LJT
Cormed, Inc., Sub. C.R.Bard, Inc.
General Hospital · 57d
Cleared Nov 26, 1985
CORNING MAGIC MAB HCG RADIOIMMUNOASSAY
K854024 · JHI
Corning Medical & Scientific
Chemistry · 57d
Cleared Nov 26, 1985
EXCEL BRACKET ADHESIVE
K854050 · DYH
Johnson & Johnson Professionals, Inc.
Dental · 54d
Cleared Nov 26, 1985
UNITEK LIFT-OFF DEBRACKETING INSTRUMENT
K854088 · JEX
Unitex Corp.
Dental · 50d
Cleared Nov 26, 1985
MEDSURG ULTRASOUND BIOPSY TRAY
K854289 · FCG
Medsurg Industries, Inc.
Gastroenterology & Urology · 32d
Cleared Nov 26, 1985
MED SURG PERCUTANEOUS ASPIRATION BIOPSY(PAB)TRAY
K854291 · KNW
Medsurg Industries, Inc.
Gastroenterology & Urology · 32d
Cleared Nov 26, 1985
MEDSURG ARTHROGRAM TRAY
K854292 · LRO
Medsurg Industries, Inc.
General & Plastic Surgery · 32d
Cleared Nov 26, 1985
MEDSURG PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAM
K854297 · KNW
Medsurg Industries, Inc.
Gastroenterology & Urology · 32d
Cleared Nov 26, 1985
TECHNICON RA-500 SYSTEM
K854345 · JJC
Technicon Instruments Corp.
Chemistry · 29d
Cleared Nov 26, 1985
PLATELET-TROL II
K854353 · JPK
R&D Systems, Inc.
Hematology · 29d
Cleared Nov 26, 1985
AUTOSCAN W/A SYSTEM
K854448 · JTO
American Micro Scan
Microbiology · 21d
Cleared Nov 26, 1985
RAICHEM/K.E
K854540 · JJQ
Reagents Applications, Inc.
Chemistry · 13d
Cleared Nov 25, 1985
CHEMSPOR
K844479 · FRC
American Sterilizer Co.
General Hospital · 371d
Cleared Nov 25, 1985
72 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPL
K850682 · DDB
Kent Laboratories, Inc.
Immunology · 277d