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
57961–57984 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 07, 2007
LIMITORR VOLUME LIMITING EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM, MODELS...
K072929 · JXG
Integra LifeSciences Corporation
Neurology · 52d
Cleared Dec 07, 2007
ONEPORT SURGICAL TROCAR SYSTEM
K073009 · GCJ
Conmed Corporation
General & Plastic Surgery · 43d
Cleared Dec 07, 2007
HEARTWAY POWER MOBILITY SCOOTER, MODEL PT7
K073044 · INI
Heartway Medical Products Co., Ltd.
Physical Medicine · 39d
Cleared Dec 07, 2007
VALENCIA SKIN APPLICATOR SET, MODEL: 189.701
K073107 · JAQ
Nucletron Corporation
Radiology · 35d
Cleared Dec 07, 2007
IDRIVES, IDRIVEC, IDRIVEF WITH VASCULAR INDICATIONS
K073148 · GDW
Power Medical Interventions, Inc.
General & Plastic Surgery · 29d
Cleared Dec 07, 2007
VITROS CHEMISTRY PRODUCTS K+ SLIDES AND CALIBRATOR KIT 2
K073157 · CEM
Ortho-Clinical Diagnostics, Inc.
Chemistry · 29d
Cleared Dec 07, 2007
CINCH KNOTLESS FIXATION IMPLANT SYSTEM
K073226 · MBI
C2m Medical, Inc.
Orthopedic · 22d
Cleared Dec 07, 2007
D-STAT DRY CLEAR HEMOSTATIC BANDAGE, MODEL 3005
K073264 · QSX
Vascular Solutions, Inc.
General & Plastic Surgery · 17d
Cleared Dec 07, 2007
DO-ALL DENTAL HANDPIECE LUBRICANT
K073353 · EFB
Prodrive Systems, Inc.
Dental · 8d
Cleared Dec 07, 2007
ELECTROPHYSIOLOGY SYSTEMS INTEGRATOR (EPSI)
K073372 · DXJ
Systemsone
Cardiovascular · 4d
Cleared Dec 06, 2007
SAN SHIH POWERED MUSCLE STIMULATOR, MODEL 202
K071093 · IPF
San Shih Electrical Enterprise Co., Ltd.
Physical Medicine · 232d
Cleared Dec 06, 2007
ATHENA MULTI-LYTE GBM TEST SYSTEM
K071219 · MVJ
Zeus Scientific, Inc.
Immunology · 218d
Cleared Dec 06, 2007
FASTPACK HCG IMMUNOASSAY
K072264 · JHI
Qualigen, Inc.
Chemistry · 113d
Cleared Dec 06, 2007
CONTROLLED DELIVERY FOR OSTEOPLASTY (CDO SYSTEM) AND GRAFT PREPARATION SYSTEM
K072330 · FMF
Biomet, Inc.
General Hospital · 108d
Cleared Dec 06, 2007
LEGION STEM WITH HOLES
K072531 · JWH
Smith & Nephew, Inc.
Orthopedic · 90d
Cleared Dec 06, 2007
SPI SYSTEM DENTAL IMPLANTS
K072649 · DZE
Thommen Medical AG
Dental · 78d
Cleared Dec 06, 2007
CARDICA C-PORT FLEX-A DISTAL ANASTOMOSIS SYSTEM, MODEL FG-000150
K073123 · FZP
Cardica, Inc.
General & Plastic Surgery · 30d
Cleared Dec 06, 2007
EXPEDIUM SPINE SYSTEM
K073126 · NKB
Depuy Spine, Inc.
Orthopedic · 30d
Cleared Dec 06, 2007
MANTIS SPINAL SYSTEM
K073151 · NKB
Stryker Corp.
Orthopedic · 28d
Cleared Dec 05, 2007
CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1005
K072558 · QYX
Cardionet, Inc.
Cardiovascular · 85d
Cleared Dec 05, 2007
BISICO IMPRESSION SILICONES & ALGINATES
K072577 · ELW
Bisico GmbH & CO KG
Dental · 83d
Cleared Dec 05, 2007
VALEO VBR
K073125 · MQP
Amedica Corp.
Orthopedic · 29d
Cleared Dec 05, 2007
SPI ART ABUTMENT
K073141 · NHA
Thommen Medical AG
Dental · 28d
Cleared Dec 05, 2007
ORTHOGON
K073271 · LLZ
Agfa Healthcare Corporation
Radiology · 14d