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
82345–82368 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 11, 2000
BMT ANSCORE HEALTH MANAGEMENT SYSTEM
K993875 · DPS
Boston Medical Technologies, Inc.
Cardiovascular · 270d
Cleared Aug 11, 2000
NIPROTECT POWDER-FREE NITRILE EXAMINATION GLOVES
K994124 · LZA
Mapa Professional
General Hospital · 248d
Cleared Aug 10, 2000
RS-4M+MUSCLE STIMULATOR
K000114 · IPF
Rs Medical
Physical Medicine · 209d
Cleared Aug 10, 2000
POWDER FREE LATEX PATIENT EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50...
K000913 · LYY
Handsafe Products Sdn. Bhd.
General Hospital · 141d
Cleared Aug 10, 2000
CARDIOSET (HARDWARE), MODEL HO4
K001091 · DXH
Next Millennium Software Solutions, Inc.
Cardiovascular · 128d
Cleared Aug 10, 2000
SIGMA DIAGNOSTICS INFINITY GLUCOSE REAGENT, MODELS 17-25, 17-100P, 17-500P,...
K001403 · CFR
Sigma Diagnostics, Inc.
Chemistry · 99d
Cleared Aug 10, 2000
THE FUGO BLADE
K001498 · NCR
Medisurg , Ltd.
Ophthalmic · 87d
Cleared Aug 10, 2000
ULTIMA METAL-ON-METAL ACETABULAR CUP
K001523 · KWA
DePuy Orthopaedics, Inc.
Orthopedic · 86d
Cleared Aug 10, 2000
STEERABLE RETROGRADE CARDIOPLEGIA CANNULA WITH AND WITHOUT DURAFLO TREATMENT,...
K001565 · DWF
Edwards Lifesciences, LLC
Cardiovascular · 83d
Cleared Aug 10, 2000
MALLARD AIR OXYGEN ACCUBLENDER
K001609 · BZR
Mallard Medical, Inc.
Anesthesiology · 78d
Cleared Aug 10, 2000
PERMLASTIC 2
K001655 · ELW
Kerr Corp.
Dental · 71d
Cleared Aug 10, 2000
DC-TELL
K001799 · EBF
Austenal, Inc.
Dental · 57d
Cleared Aug 10, 2000
DC ZIRKON
K001815 · EIH
Austenal, Inc.
Dental · 56d
Cleared Aug 10, 2000
PARASPA PARAFFIN BATH, PARASPAP MINI, PARASPA ULTRA
K001860 · IMC
Homedics, Inc.
Physical Medicine · 52d
Cleared Aug 10, 2000
CLEARFIL REPAIR
K001914 · KLE
Kuraray Company, Ltd.
Dental · 48d
Cleared Aug 10, 2000
PASCO MIC AND MIC/ID PANELS
K001953 · JWY
Pasco Laboratories, Inc.
Microbiology · 44d
Cleared Aug 10, 2000
LIFESHIELD ADDITIVE PIERCING PIN
K002006 · FPA
Abbott Laboratories
General Hospital · 38d
Cleared Aug 10, 2000
BIOTRACE, MODEL 1730
K002063 · MYU
Bryan Corp.
Neurology · 34d
Cleared Aug 10, 2000
INVACARE LIFT CHAIR
K002171 · INO
Invacare Corp.
Physical Medicine · 22d
Cleared Aug 10, 2000
POLYGLYCOLIC ACID (PGA), ABSORBABLE SURGICAL SUTURE (USP)
K002190 · GAM
Cp Medical
General & Plastic Surgery · 21d
Cleared Aug 10, 2000
CARONY
K002205 · IOR
Bruno Independent Living Aids, Inc.
Physical Medicine · 20d
Cleared Aug 10, 2000
ELECSYS CA 15-3 CALCHECK
K002353 · JIS
Roche Diagnostics Corp.
Immunology · 8d
Cleared Aug 10, 2000
PROTEMP H
K002364 · EBG
Espe Dental AG
Dental · 7d
Cleared Aug 10, 2000
SIEMENS INTEGRATED OPERATING SYSTEM (SIOS)
K994231 · ODA
Siemens Medical Corp.
Gastroenterology & Urology · 238d