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
63385–63408 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 13, 2006
BIOFLEX PRESCRIPTION SYSTEM AND RELATED TREATMENT HEADS
K051875 · ILY
Meditech International, Inc.
Physical Medicine · 245d
Cleared Mar 13, 2006
ONE TRAY SEALED STERILIZATION CONTAINER
K052567 · KCT
Sterile Containment Technology, LLC
General Hospital · 175d
Cleared Mar 13, 2006
RDI HSFERRITIN KIT
K053211 · DBF
Reference Diagnostics, Inc.
Immunology · 117d
Cleared Mar 13, 2006
PVS 2000 SYNCHRO2 GUIDEWIRE
K053268 · DQX
Boston Scientific - Precision Vascular
Cardiovascular · 110d
Cleared Mar 13, 2006
FERRITIN CALIBRATOR SET, CATALOG NO. 8203
K053291 · JIT
Reference Diagnostics, Inc.
Chemistry · 108d
Cleared Mar 13, 2006
FIDIS CONNECTIVE 10, MODEL MX006
K053653 · LLL
Biomedical Diagnostics (Bmd) SA
Immunology · 73d
Cleared Mar 13, 2006
EBI VERTEBROPLASTY SYSTEMS
K060148 · NDN
Ebi, L.P.
Orthopedic · 53d
Cleared Mar 13, 2006
COBAS 6000 SERIES SYSTEM
K060373 · CEM
Roche Diagnostics
Immunology · 28d
Cleared Mar 13, 2006
INION HEXALON BIODEGRADABLE ACL/PCL SCREW
K060393 · HWC
Inion , Ltd.
Orthopedic · 26d
Cleared Mar 13, 2006
CONCERTO BIPOLAR NEEDLE ELECTRODE
K060419 · GEI
Boston Scientific Corp
General & Plastic Surgery · 24d
Cleared Mar 13, 2006
QUANTUM ANTERIOR CERVICAL PLATE SYSTEM
K060491 · KWQ
Quantum Orthopedics, Inc.
Orthopedic · 17d
Cleared Mar 13, 2006
INTUITIVE SURGICAL SEAL
K060534 · GCJ
Applied Medical Resources Corp.
General & Plastic Surgery · 13d
Cleared Mar 10, 2006
ELECTROPULSE
K051128 · GZJ
Pain Relief Technologies
Neurology · 311d
Cleared Mar 10, 2006
MIGWANG COMFORT 38 (POLYMACON) SPHERICAL AND TORIC SOFT CONTACT LENS FOR...
K051477 · LPL
Mi Gwang Contact Lens Co., Ltd.
Ophthalmic · 280d
Cleared Mar 10, 2006
MIGUE
K052212 · IYE
Direx Systems Corp.
Radiology · 207d
Cleared Mar 10, 2006
CT PERFUSION 4
K052839 · JAK
Ge Healthcare
Radiology · 154d
Cleared Mar 10, 2006
BIOGEL SKINSENSE POWDER-FREE NON-LATEX SURGEON'S GLOVE
K053102 · KGO
Regent Medical Americas, LLC
General Hospital · 126d
Cleared Mar 10, 2006
MAGBODY DT-600
K053284 · GZJ
Durtech System Corp.
Neurology · 105d
Cleared Mar 10, 2006
PREMIER PLATINUM HPSA PLUS, MODELS 601396, 601480
K053335 · LYR
Meridian Bioscience, Inc.
Microbiology · 99d
Cleared Mar 10, 2006
COMPASS COMPRESSION ASSIST HANDLE
K053398 · DXC
Semler Technologies, Inc. Dba
Cardiovascular · 94d
Cleared Mar 10, 2006
DA VINCI FEMTOSECOND SURGICAL LASER
K053511 · GEX
Sie Ltd Surgical Instrument Engineering
General & Plastic Surgery · 84d
Cleared Mar 10, 2006
RT300-S, MODEL FA100052
K060032 · GZI
Restorative Therapies, Inc.
Neurology · 64d
Cleared Mar 10, 2006
VIX WIN PRO
K060178 · MUH
Gendex Dental Systems
Radiology · 46d
Cleared Mar 10, 2006
CAREO SAFETY SYRINGE 1CC/ML, MODELS...
K060208 · MEG
Life-Shield Products, Inc.
General Hospital · 42d