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
65065–65088 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 22, 2005
CARDIOSTREAM SONOAIM
K051853 · LLZ
Cardiostream, LLC
Radiology · 45d
Cleared Aug 22, 2005
FLEXIBLE INTRODUCER CANNULA, MODEL 135-1837
K051860 · MIA
Epimed International, Inc.
Anesthesiology · 45d
Cleared Aug 22, 2005
MODUS MODULAR DISTRACTION OSTEOGENESIS SYSTEM
K051946 · MQN
Medartis, Inc.
Dental · 35d
Cleared Aug 22, 2005
RADIONICS CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONE
K051947 · LFL
Radionics, A Division of Tyco...
General & Plastic Surgery · 35d
Cleared Aug 22, 2005
PROFEMUR RENAISSANCE HIP STEM
K051995 · JDL
Wrightmedicaltechnologyinc
Orthopedic · 28d
Cleared Aug 22, 2005
BISCOVER LED
K051999 · EBD
Bisco, Inc.
Dental · 28d
Cleared Aug 22, 2005
IRON STANDARD
K052002 · JIT
Roche Diagnostics Corp.
Chemistry · 28d
Cleared Aug 22, 2005
MODIFICATION TO: TITANIUM TELEGRAPH HUMERAL NAIL
K052058 · HSB
Fournitures Hospitalieres Industrie
Orthopedic · 24d
Cleared Aug 22, 2005
ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES
K052065 · KTT
Alliance Medical Corp.
Orthopedic · 24d
Cleared Aug 22, 2005
MODIFICATION TO: CD HORIZON SPINAL SYSTEM
K052187 · NKB
Medtronic Sofamor Danek
Orthopedic · 11d
Cleared Aug 22, 2005
MODIFICATION TO EN-BLOC BIOPSY SYSTEM
K052246 · GEI
Neothermia Corporation
General & Plastic Surgery · 5d
Cleared Aug 19, 2005
DELTA PUNCTUM PLUG
K050851 · LZU
Delta Life Science, Inc.
Ophthalmic · 137d
Cleared Aug 19, 2005
DIVAS DUAL PLEASURE MALE LATEX CONDOM
K051273 · HIS
Eagle Twe, Inc.
Obstetrics & Gynecology · 94d
Cleared Aug 19, 2005
CONSERVE TOTAL FEMORAL HEAD
K051348 · JDL
Wrightmedicaltechnologyinc
Orthopedic · 87d
Cleared Aug 19, 2005
STERRAD STERILIZER CYCLESURE TEST PACK
K051643 · FRC
Advanced Sterilization Products
General Hospital · 60d
Cleared Aug 19, 2005
VYGON NUTRILINE CATHETERS
K051690 · LJS
Vygon Corp.
General Hospital · 57d
Cleared Aug 19, 2005
AMLUCK, YA HORNG
K051863 · DXN
Ya Horng Electronic Co., Ltd.
Cardiovascular · 42d
Cleared Aug 19, 2005
VOLCANO S5 IMAGING SYSTEM, MODEL 804200-001
K051920 · IYO
Volcano Corporation
Radiology · 35d
Cleared Aug 19, 2005
CARDIONAVIGATOR +
K051960 · DXH
Del Mar Reynolds Medical, Ltd.
Cardiovascular · 31d
Cleared Aug 19, 2005
DVT SCANNER
K051980 · JAK
Imaging Sciences Intl., Inc.
Radiology · 29d
Cleared Aug 19, 2005
FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020
K052082 · JMG
Beckman Coulter, Inc.
Immunology · 17d
Cleared Aug 19, 2005
TEM 3000 HEAD COIL
K052200 · MOS
Mr Instruments, Inc.
Radiology · 7d
Cleared Aug 18, 2005
TENACORE TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING
K043075 · HGM
Tenacore Holdings, Inc.
Obstetrics & Gynecology · 283d
Cleared Aug 18, 2005
2.5 MM TURBO CLIRPATH EXCIMER LASER CATHETER, MODEL 225-011
K043465 · PDU
Spectranetics Corp.
Cardiovascular · 246d