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
64345–64368 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 16, 2005
VERSA-LINK PORCELAIN BONDING SYSTEM
K052699 · KLE
Sultan Chemists, Inc.
Dental · 49d
Cleared Nov 16, 2005
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K052931 · MQP
Medtronic Sofamor Danek
Orthopedic · 28d
Cleared Nov 16, 2005
THE ZIMMER TMT TRABECULAR METAL VERTEBRAL BODY REPLACEMENT SYSTEM
K052950 · MQP
Zimmer Trabecular
Orthopedic · 27d
Cleared Nov 16, 2005
COLOR NIO 2MP, E-2320 C
K052958 · LLZ
Barcoview
Radiology · 26d
Cleared Nov 16, 2005
SLENDERTONE GYMBODY, MODEL 512-01
K052969 · NGX
Bio-Medical Research, Ltd.
Physical Medicine · 26d
Cleared Nov 16, 2005
STRYKER SPINE TRIO SPINAL FIXATION SYSTEM
K052971 · MNI
Stryker Spine
Orthopedic · 23d
Cleared Nov 16, 2005
MODELS HRS-63-8 AND HRS-127-8 SHOULDER ARRAY COILS
K053017 · MOS
Invivo Corporation
Radiology · 21d
Cleared Nov 16, 2005
PACP SYSTEM
K053053 · KWQ
Pioneer Surgical Technology
Orthopedic · 16d
Cleared Nov 16, 2005
SONOSITE MICROMAXX DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES)
K053069 · IYN
Sonosite,Inc.
Radiology · 15d
Cleared Nov 16, 2005
SIGMA 5000 SERIES IMAGIC ULTRASOUND SYSTEM
K053084 · IYN
Kontron Medical Systems Sas
Radiology · 14d
Cleared Nov 15, 2005
TOPEZ TOTAL ANKLE REPLACEMENT
K051023 · HSN
Topez Orthopedics, Inc.
Orthopedic · 207d
Cleared Nov 15, 2005
PLEURX PERITONEAL CATHETER KIT AND PLEURX DRAINAGE KITS
K051711 · PNG
Denver Biomedical, Inc.
Gastroenterology & Urology · 141d
Cleared Nov 15, 2005
NOVUS 3000 LASER SYSTEM AND DELIVERY DEVICES
K052526 · GEX
Lumenis, Inc.
General & Plastic Surgery · 62d
Cleared Nov 15, 2005
MODULAR THUMB IMPLANT, MODELS...
K052596 · KYI
Biopro, Inc.
Orthopedic · 55d
Cleared Nov 15, 2005
MODIFICATION TO:SANARUS VISICA TREATMENT SYSTEM , MODELS VS2000
K052861 · GEH
Sanarus Medical, Inc.
General & Plastic Surgery · 35d
Cleared Nov 15, 2005
POLY SILOXANE IMPRESSION MATERIAL
K053014 · ELW
Clinician'S Choice Dental Products, Inc.
Dental · 20d
Cleared Nov 15, 2005
SILVERFIL
K053114 · EJJ
Dunia Perwira Manufacturing Sdn. Bhd.
Dental · 8d
Cleared Nov 14, 2005
RBK PATELLA FEMORAL KNEE
K050473 · KRR
Global Orthopaedic Technology, USA, Inc.
Orthopedic · 263d
Cleared Nov 14, 2005
AESKULISA ASCA A
K051492 · NBT
Aesku, Inc.
Immunology · 161d
Cleared Nov 14, 2005
OLYMPUS CHOLEDOCHOSCOPE, MODEL XCHF-BP160F
K051886 · FBN
Olympus Medical Systems Corporation
Gastroenterology & Urology · 125d
Cleared Nov 14, 2005
SUPERDIMENSION/BRONCHUS PREMIUM
K052852 · JAK
Superdimension, Ltd.
Radiology · 34d
Cleared Nov 14, 2005
TELITHROMYCIN 15UG BBL SENSI-DISC
K052876 · JTN
Becton, Dickinson & CO
Microbiology · 33d
Cleared Nov 10, 2005
C-PORT ANASTOMOSIS SYSTEM (DEPLOYMENT SYSTEM, CLIP, ACCESSORIES), MODEL...
K040832 · FZP
Cardica, Inc.
General & Plastic Surgery · 589d
Cleared Nov 10, 2005
EXTENDED MEASUREMENTS SYSTEM
K051450 · DQD
Inovise Medical, Inc.
Cardiovascular · 161d