Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
81721–81744 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Oct 24, 2000
VENTURE IDD OXYGEN CONSERVING DEVICE IDD 20EX AND 50EX
K002284 · NFB
Invacare Corp.
Anesthesiology · 90d
Cleared Oct 24, 2000
ELRAN 01 SYSTEM
K002431 · GCJ
Envision Advanced Medical System, Ltd.
General & Plastic Surgery · 77d
Cleared Oct 24, 2000
SIMPLICITY SOFT INFUSION SET
K002492 · FPA
Sterling Medivations, Inc.
General Hospital · 71d
Cleared Oct 24, 2000
EQUITY
K002826 · EJT
Jensen Industries, Inc.
Dental · 43d
Cleared Oct 24, 2000
ANSPACH ANGLED MICRONOSE ATTACHMENT
K002903 · HBE
The Anspach Effort, Inc.
Neurology · 36d
Cleared Oct 24, 2000
DERMAGRIP POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE STERILE,...
K002975 · LYY
Wrp Specialty Products Sdn. Bhd.
General Hospital · 32d
Cleared Oct 24, 2000
MEDLINE STERILE VINYL EXAM GLOVES, POWDER FREE, YELLOW
K003091 · LYZ
Medline Industries, Inc.
General Hospital · 21d