FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
115561–115584 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 27, 1993
URINE MAGNESIUM METHOD FOR TECHNICON CHEM SYSTEMS
K926144 · JGJ
Heraeus Kulzer, Inc.
Chemistry · 51d
Cleared Jan 27, 1993
WIDEX MODEL D8 (HEARING AID)
K926244 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 47d
Cleared Jan 27, 1993
PREMIER C. DIFFICILE, MODIFICATION
K926442 · LLH
Meridian Diagnostics, Inc.
Microbiology · 42d
Cleared Jan 26, 1993
WEINGARTEN TM CAPNOGRAPHIC INTUBATION STYLETTE
K904999 · BSR
Opticon Medical, Inc.
Anesthesiology · 812d
Cleared Jan 26, 1993
RESPONSE(TM) STEERABLE CATHETER
K913940 · DRA
Daig Corp.
Cardiovascular · 511d
Cleared Jan 26, 1993
LARYNGOSCOPE RIGID
K922019 · CCW
Eastmed Enterprises, Inc.
Anesthesiology · 271d
Cleared Jan 26, 1993
MILNE-CHARKOT SHOTT-THUR CASSETTE HOLDER
K923334 · IXA
Cook, Inc.
Radiology · 203d
Cleared Jan 26, 1993
HEAT MOISTURE CONDENSER
K923910 · BYD
Concord/Portex
Anesthesiology · 175d
Cleared Jan 26, 1993
THE GALILEO VEGA-24 ELECTROENCEPHALOGRAPH
K923950 · GWQ
Biosound, Inc.
Neurology · 174d
Cleared Jan 26, 1993
POLYDOROS C
K924078 · IZO
Siemens Medical Solutions USA, Inc.
Radiology · 167d
Cleared Jan 26, 1993
ENDO I/A PROBE
K924149 · GCJ
Snowden-Pencer
General & Plastic Surgery · 161d
Cleared Jan 26, 1993
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (LI)
K924488 · JIH
Eastman Kodak Company
Chemistry · 145d
Cleared Jan 26, 1993
TRIGLYCERIDES
K924710 · CDT
Em Diagnostic Systems, Inc.
Chemistry · 130d
Cleared Jan 26, 1993
MICROPLATE CANNABINOIDS ASSAY
K924815 · LDJ
Solarcare Technologies Corp,Inc.
Toxicology · 123d
Cleared Jan 26, 1993
IMMUNOCARD(TM) C. DIFFICILE
K924979 · LLH
Meridian Diagnostics, Inc.
Microbiology · 117d
Cleared Jan 26, 1993
ABBOTT IMX T4
K925110 · CDX
Abbott Laboratories
Chemistry · 109d
Cleared Jan 26, 1993
OLYMPUS URIC ACID REAGENT
K925113 · KNK
Olympus Corp.
Chemistry · 109d
Cleared Jan 26, 1993
AUTO SUTURE ENDOSCOPIC KNOT PUSHER
K925149 · GCJ
United States Surgical, A Division of...
General & Plastic Surgery · 105d
Cleared Jan 26, 1993
OLYMPUS ASPARTATE AMINOTRANSFERASE REAGENT
K925155 · CIT
Olympus Corp.
Chemistry · 105d
Cleared Jan 26, 1993
MERIDIAN MEDICAL SYSTEMS BREATHING FILTER
K925217 · CAH
Merit Medical Systems, Inc.
General Hospital · 102d
Cleared Jan 26, 1993
MERIDIAN MEDICAL SYSTEMS MAPLESON D CIRCUITS
K925231 · CAI
Merit Medical Systems, Inc.
Anesthesiology · 102d
Cleared Jan 26, 1993
OLYMPUS GAMMA GLUTAMYL TRANSFERASE REAGENT
K925337 · JQB
Olympus Corp.
Chemistry · 98d
Cleared Jan 26, 1993
MAXSOFTWARE
K925547 · JQW
Diagnostic Products Corp.
Toxicology · 84d
Cleared Jan 26, 1993
ENCORE THYROGLOBULIN IGE, IGA AND IGM EIA
K925826 · JZO
Clark Laboratories, Inc.
Immunology · 71d