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
76945–76968 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 08, 2002
POWDER FREE (POLYMER COATED) NON CHLORINATED WHITE LATEX EXAMINATION GLOVES...
K013267 · LYY
Siam Sempermed Corp., Ltd.
General Hospital · 158d
Cleared Mar 08, 2002
ACTICHROME HEPARIN (ANTI-FXA), MODEL 832
K013318 · KFF
American Diagnostica, Inc.
Hematology · 154d
Cleared Mar 08, 2002
LP(A)-LATEX SEIKEN ASSAY KIT
K013359 · DFC
Denka Seiken'S
Chemistry · 149d
Cleared Mar 08, 2002
MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONS
K013662 · JHO
Quantimetrix Corp.
Chemistry · 122d
Cleared Mar 08, 2002
MODIFICATION TO: MED-RO REVERSE OSMOSIS SYSTEM
K013677 · FIP
Usfilter/Ionpure, Inc.
Gastroenterology & Urology · 121d
Cleared Mar 08, 2002
EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON MATERIAL
K014052 · DYB
Edwards Lifesciences, LLC
Cardiovascular · 88d
Cleared Mar 08, 2002
CONDUIT TCP GRANULES
K014053 · MQV
Depuyacromed
Orthopedic · 88d
Cleared Mar 08, 2002
EDWARDS LIFESCIENCES SWAN-GANZ MONITORING CATHETER WITH OLIGON MATERIAL
K014054 · DQO
Edwards Lifesciences, LLC
Cardiovascular · 88d
Cleared Mar 08, 2002
DERMASTAR ER:YAG LASER SYSTEM
K014057 · GEX
Asclepion-Meditec AG
General & Plastic Surgery · 88d
Cleared Mar 08, 2002
FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION UH)
K014072 · KWY
Disc-O-Tech Medical Technologies, Ltd.
Orthopedic · 88d
Cleared Mar 08, 2002
NEWGEN/UNIVERSAL MANDIBULAR SYSTEM
K014263 · JEY
Stryker Instruments
Dental · 71d
Cleared Mar 08, 2002
SALUTE, MODEL 3022
K014286 · GDW
Onux Medical, Inc.
General & Plastic Surgery · 71d
Cleared Mar 08, 2002
EN 600-658, EN 600-666, EN 600-664, EN 600-690, EN 600-651, EN 600-663, EN...
K020094 · IOR
Regulatory Insight, Inc.
Physical Medicine · 56d
Cleared Mar 08, 2002
SL 803, SL 804, SL 807, SL 809, SL 506, SL 501, SL 805 AND SL 801 MECHANICAL...
K020100 · IOR
Regulatory Insight, Inc.
Physical Medicine · 56d
Cleared Mar 08, 2002
BIOTECH MANUAL WHEELCHAIR, A1000 SUPER SPORT WHEELCHAIR
K020188 · IOR
Taiwan Armada Enterprise Co., Ltd.
Physical Medicine · 49d
Cleared Mar 08, 2002
SERRALENE, MODEL CATALOG NO 1S
K020265 · GAW
Serral, S.A. DE C.V.
General & Plastic Surgery · 42d
Cleared Mar 08, 2002
STERN MICRO ERA ATTACHMENT SYSTEM
K020391 · DZE
Sterngold
Dental · 30d
Cleared Mar 08, 2002
MODIFICATION TO EBI XFIX DFS OPTIROM ELBOW FIXATOR
K020403 · KTT
Ebi, L.P.
Orthopedic · 29d
Cleared Mar 08, 2002
SAS VALUE HCG
K020438 · JHI
Sa Scientific, Inc.
Chemistry · 25d
Cleared Mar 08, 2002
MODIFICATION TO CORLINK AUTOMATED ANASTOMOTIC DEVICE
K020470 · FZP
Bypass , Ltd.
General & Plastic Surgery · 24d
Cleared Mar 08, 2002
BIOTECH MANUAL WHEELCHAIR B900 SUPER LIGHT WHEELCHAIR
K020472 · IOR
Taiwan Armada Enterprise Co., Ltd.
Physical Medicine · 24d
Cleared Mar 08, 2002
DIEGO POWERED DISSECTOR AND DRILL SYSTEM
K020594 · ERL
Gyrus Ent LLC
Ear, Nose, Throat · 14d
Cleared Mar 08, 2002
SANARUS VISICA TREATMENT SYSTEM
K020605 · GEH
Sanarus Medical, Inc.
General & Plastic Surgery · 11d
Cleared Mar 07, 2002
MASTERGRAFT RESORBABLE CERAMIC GRANULES
K012506 · MQV
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 213d