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
62305–62328 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 10, 2006
DIMENSION VISTA FLEX REAGENT CARTRIDGES
K061655 · LDP
Dade Behring, Inc.
Chemistry · 27d
Cleared Jul 10, 2006
CELL-DYN RUBY SYSTEM
K061667 · GKZ
Abbott Laboratories
Hematology · 26d
Cleared Jul 10, 2006
SOLAR PUREFIX HA SHOULDER
K061677 · HSD
Howmedica Osteonics Corp.
Orthopedic · 25d
Cleared Jul 10, 2006
DIMENSION VISTA SYSTEM CREATINE KINASE CALIBRATOR (CK CAL - KC340)
K061702 · JIT
Dade Behring, Inc.
Chemistry · 24d
Cleared Jul 10, 2006
EZ-CONNECT
K061771 · FPA
Vidacare Corporation
General Hospital · 17d
Cleared Jul 07, 2006
LIV MEDICA CPR FACE MASK
K052458 · CBP
Liv Medica Products Pvt. , Ltd.
Anesthesiology · 303d
Cleared Jul 07, 2006
NESS L300
K053468 · GZI
Ness-Neuromuscular Electrical...
Neurology · 206d
Cleared Jul 07, 2006
EPISTAT, V-STAT, MODELS EPISTAT-001-01, V-STAT-001-01
K060289 · KNA
Frontline Medical
Obstetrics & Gynecology · 151d
Cleared Jul 07, 2006
HEMCON DENTAL DRESSING, 1 DRESSING, 4 DRESSING, 1 DRESSING, BOX OF 12, 4...
K060363 · OLR
Hemcon, Inc.
General & Plastic Surgery · 144d
Cleared Jul 07, 2006
POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES W/ALOE VERA, GREEN COLOR
K060785 · LYZ
Ever Light Plastic Products Co., Ltd.
General Hospital · 107d
Cleared Jul 07, 2006
STARCLOSE INTRODUCER SET MODEL- 1002
K060902 · DYB
Abbott Vascular, Inc.
Cardiovascular · 95d
Cleared Jul 07, 2006
WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS
K060942 · FIP
Bob J. Johnson & Associates
Gastroenterology & Urology · 92d
Cleared Jul 07, 2006
ZIEHM VARIO 3D DIGITAL MOBILE IMAGING SYSTEM
K061310 · JAK
Ziehm Imaging, Inc.
Radiology · 58d
Cleared Jul 07, 2006
ZODIAC ADJUSTABLE BRIDGES, MODELS 11-20XX,11-25XX,11-30XX,11-35XX
K061321 · MNH
Alphatec Spine, Inc.
Orthopedic · 57d
Cleared Jul 07, 2006
INFINITY MASIMO SET SP02 POD
K061329 · DQA
Draeger Medical Systems, Inc.
Anesthesiology · 56d
Cleared Jul 07, 2006
APEX PINS
K061493 · JDW
Stryker Howmedica Osteonics
Orthopedic · 37d
Cleared Jul 07, 2006
ZIEHM VISION FD DIGITAL MOBILE IMAGING SYSTEM
K061534 · OWB
Ziehm Imaging, Inc.
Radiology · 35d
Cleared Jul 07, 2006
TRIDENT CONSTRAINED ACETABULAR INSERT
K061654 · KWZ
Howmedica Osteonics Corp.
Orthopedic · 24d
Cleared Jul 07, 2006
CLEVER TD-1112 EAR/SKIN/SURFACE IR THERMOMETER
K061800 · FLL
Taidoc Technology Corporation
General Hospital · 11d
Cleared Jul 06, 2006
BI-OSTETIC FOAM, CEM-OSTETIC FOAM, TRI-OSTETIC FOAM, GENEROS FOAM
K053213 · MQV
Berkeley Advanced Biomaterials, Inc.
Orthopedic · 232d
Cleared Jul 06, 2006
PRODIGY
K053593 · NBW
Diagnostic Devices, Inc.
Chemistry · 195d
Cleared Jul 06, 2006
LUMENIS ONE FAMILY OF SYSTEMS
K060448 · GEX
Lumenis, Ltd.
General & Plastic Surgery · 135d
Cleared Jul 06, 2006
BALANCED KNEE SYSTEM MODULAR REVISION KNEE SYSTEM
K060569 · JWH
Ortho Development Corp.
Orthopedic · 125d
Cleared Jul 06, 2006
SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL...
K061069 · CFF
Helena Laboratories
Immunology · 80d