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
61945–61968 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 16, 2006
TDM N-ACETYLPROCAINAMIDE
K060738 · LAN
Roche Diagnostics Corp.
Toxicology · 149d
Cleared Aug 16, 2006
ACE SURGICAL ORTHODONTIC BONE SCREW SYSTEMS, 1.2/1.5 MM X 6MM,8MM, MODEL...
K061397 · OAT
Ace Surgical Supply Co., Inc.
Dental · 89d
Cleared Aug 16, 2006
EXCEL HIGH SPEED DENTAL HANDPIECE
K061581 · EFA
Orthosource, Inc.
Dental · 70d
Cleared Aug 16, 2006
DMS 300-7
K062007 · DSH
Diagnostic Monitoring Software
Cardiovascular · 30d
Cleared Aug 16, 2006
MODEL 3875 1 X 8 SC TEST STIMULATION LEAD
K062041 · GZB
Medtronic, Inc.
Neurology · 28d
Cleared Aug 16, 2006
VERTEBRON SCP CERVICAL PLATE SYSTEM
K062110 · KWQ
Vertebron, Inc.
Orthopedic · 23d
Cleared Aug 16, 2006
AVS PL PEEK SPACER SYSTEM
K062132 · MQP
Stryker Spine
Orthopedic · 21d
Cleared Aug 16, 2006
CREATININE KINASE MB ISOENZYME VERIFIER, MODEL DC27
K062152 · JIT
Dade Behring, Inc.
Chemistry · 20d
Cleared Aug 16, 2006
MODIFICATION TO ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM
K062195 · NBW
Lifescan, Inc.
Chemistry · 15d
Cleared Aug 16, 2006
JAN MAO WHEELCHAIR, MODELS JMC612-FL318EPP AND JMC612-FL418EPP
K062218 · IOR
Jan Mao Industries Co., Ltd.
Physical Medicine · 15d
Cleared Aug 15, 2006
CYAN DXD, MULTITEST CD8/CD4/CD3, CD3-FITC, CD3-RPE, CD3-APC AND FLUOROSPHERES
K060423 · GKZ
Dakocytomation California, Inc.
Hematology · 179d
Cleared Aug 15, 2006
SURESAVE TM SELF-EXPANDABLE NITINOL STENT AND PRECISION TM DELIVERY...
K060557 · FGE
Idev Technologies, Inc.
Gastroenterology & Urology · 166d
Cleared Aug 15, 2006
NAVIAID BGE DEVICE, MODEL 21-001
K060923 · FDA
Smart Medical Systems , Ltd.
Gastroenterology & Urology · 133d
Cleared Aug 15, 2006
PLAYTEX EMBRACE PETITE BREAST PUMP
K061013 · HGX
Playtex Products, Inc.
Obstetrics & Gynecology · 124d
Cleared Aug 15, 2006
DEEPWAVE PERCUTANEOUS NEUROMODULATION PAIN THERAPY SYSTEM
K061166 · NHI
Biowave Corporation
Neurology · 110d
Cleared Aug 15, 2006
FAXITRON DIGITAL RADIOGRAPHY SYSTEM, MODEL DX-50
K061361 · MWP
Faxitron X-Ray Corp.
Radiology · 91d
Cleared Aug 15, 2006
SPINAL USA VBR SYSTEM
K061752 · MQP
Spinal USA
Orthopedic · 55d
Cleared Aug 15, 2006
9900 PLUS MOBILE FLUOROSCOPY SYSTEM WITH 3D AND NAVIGATION OPTIONS
K061953 · OWB
Ge Oec Medical Systems
Radiology · 36d
Cleared Aug 15, 2006
DRY LASER IMAGER, DRYPRO MODEL 832
K061999 · LMC
Konica Minolta Medical & Graphic, Inc.
Radiology · 32d
Cleared Aug 15, 2006
MODIFICATION TO QUANTUM VERTEBRAL BODY REPLACEMENT
K062004 · MQP
Quantum Orthopedics, Inc.
Orthopedic · 29d
Cleared Aug 15, 2006
OMEGA 3 SYSTEM
K062066 · KTT
Howmedica Osteonics Corp.
Orthopedic · 25d
Cleared Aug 15, 2006
ISCIENCE SURGICAL FIBEROPTIC ILLUMINATOR, MODEL FI - 100
K062259 · MPA
Iscience Surgical
Ophthalmic · 11d
Cleared Aug 14, 2006
REGENEREX ULTRA POROUS CONSTRUCT-FEMORAL AND TIBIAL KNEE AUGMENTS
K053505 · MBH
Biomet Manufacturing, Inc.
Orthopedic · 241d
Cleared Aug 14, 2006
NELLCOR OXIMAX N-600X PULSE OXIMETER
K060576 · DQA
Nellcor Puritan Bennett, Inc.
Anesthesiology · 161d