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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
80593–80616 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 25, 2000
DENTAL AIR FORCE HOME DENTAL CLEANING SYSTEM, MODEL NO. 0020001
K001493 · EFS
Air Force, Inc.
Dental · 166d
Cleared Oct 25, 2000
NEU-ION HEMODIALYIS WATER TREATMENT SYSTEM
K001811 · FIP
Neu-Ion, Inc.
Gastroenterology & Urology · 132d
Cleared Oct 25, 2000
DIRECT CROWN
K001884 · EBG
Flexible Dimensions, LLC
Dental · 126d
Cleared Oct 25, 2000
CARDIOBEEPER CB12/12, MODEL CB12/12
K002310 · DXH
Meridian Medical Technologies , Ltd.
Cardiovascular · 86d
Cleared Oct 25, 2000
NATURAL-KNEE II SYSTEM-DURASUL TIBIAL INSERT AND DURASUL ALL-POLY PATELLA
K002335 · JWH
Sulzer Orthopedics, Inc.
Orthopedic · 85d
Cleared Oct 25, 2000
HARDYDISK STREPTOMYCIN, 300MCG
K002368 · JTN
Hardy Diagnostics
Microbiology · 83d
Cleared Oct 25, 2000
ACCESS ALERT GAUGE
K002372 · KOC
Medisystems Corp.
Gastroenterology & Urology · 82d
Cleared Oct 25, 2000
POWER 5000 GENERAL PURPOSE COIL
K002483 · MOS
Usa Instruments, Inc.
Radiology · 72d
Cleared Oct 25, 2000
OPART, MODEL MRT-600
K002522 · MOS
Toshiba America Mri, Inc.
Radiology · 71d
Cleared Oct 25, 2000
K-ASSAY HIGH SENSITIVE CRP(2) FOR THE BECKMAN COULTER IMMAGE
K002558 · DCK
Kamiya Biomedical Co.
Immunology · 72d
Cleared Oct 25, 2000
HARDYDISK CEFUROXIME, 30MCG
K002656 · JTN
Hardy Diagnostics
Microbiology · 61d
Cleared Oct 25, 2000
MILLENNIUM EDITION 2000 ACCELERATED ELECTROFORMING SYSTEM
K002675 · EJT
Product Development Industries, Inc.
Dental · 58d
Cleared Oct 25, 2000
OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT
K002918 · DCN
Olympus America, Inc.
Immunology · 36d
Cleared Oct 25, 2000
OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER
K002982 · JJE
Olympus America, Inc.
Chemistry · 30d
Cleared Oct 25, 2000
OSCAR 2, MODEL 222
K003004 · DXN
Suntech Medical Instruments, Inc.
Cardiovascular · 30d
Cleared Oct 25, 2000
RAICHEM PHOSPORUS REAGENT
K003012 · CEO
Hemagen Diagnostics, Inc.
Chemistry · 29d
Cleared Oct 25, 2000
FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZER
K003094 · LTJ
Qualigen, Inc.
Immunology · 22d
Cleared Oct 25, 2000
HARALD NORDIN CARBONITE CARBON FIBER COMPOSITE DENTAL POST
K003219 · ELR
Harald Nordin S.A
Dental · 9d
Cleared Oct 25, 2000
HARALD NORDIN GLASSIX GLASS FIBER COMPOSITE DENTAL POST
K003221 · ELR
Harald Nordin S.A
Dental · 9d
Cleared Oct 25, 2000
STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP
K994321 · JOL
Automatic Liquid Packaging, Inc.
General Hospital · 308d
Cleared Oct 24, 2000
PDT DOSECALCULATOR, MODEL 80000
K000418 · NDC
Retinalabs.Com
General Hospital · 259d
Cleared Oct 24, 2000
EVANTGARDE/ENDEAVOR POWERED WHEELCHAIR
K000739 · ITI
Otto Bock Orthopedic Industry, Inc.
Physical Medicine · 231d
Cleared Oct 24, 2000
RADIOMED SOURCE
K001070 · KXK
Radiomed Corp.
Radiology · 204d
Cleared Oct 24, 2000
LIFE SCOPE P, MODEL BSM-4100 SERIES
K001693 · MHX
Nihon Kohden America, Inc.
Cardiovascular · 144d