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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
37513–37536 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 30, 2014
VANGUARD 360 OSSEOTI TIBIAL SLEEVE AUGMENT
K140883 · MBH
Biomet, Inc.
Orthopedic · 114d
Cleared Jul 30, 2014
ALPINE HIP STEM
K141001 · LPH
Ortho Development
Orthopedic · 103d
Cleared Jul 30, 2014
G-FORCE GEN 2 SUTURE ANCHOR SYSTEM
K141011 · MBI
Wrightmedicaltechnologyinc
Orthopedic · 103d
Cleared Jul 30, 2014
LEADERFLEX
K141026 · FOZ
Vygon
General Hospital · 99d
Cleared Jul 30, 2014
ENCOMPASS
K141130 · MUH
Panoramic Corp.
Radiology · 90d
Cleared Jul 30, 2014
LIBERTY PDX CYCLER
K141145 · FKX
Fresenius Medical Care Renal...
Gastroenterology & Urology · 89d
Cleared Jul 30, 2014
ELCAM STOPCOCKS AND MANIFOLDS
K141254 · FMG
Elcam Medical Acal
General Hospital · 77d
Cleared Jul 30, 2014
OPEN FMSEALER
K141484 · GEI
Domain Surgical, Inc.
General & Plastic Surgery · 55d
Cleared Jul 30, 2014
QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
K141778 · GAM
Surgical Specialties Corporation
General & Plastic Surgery · 28d
Cleared Jul 29, 2014
Kangli Locking Plate System
K133840 · HRS
Suzhou Kangli Orthopaedics Instrument...
Orthopedic · 223d
Cleared Jul 29, 2014
IRIX-A LUMBAR INTEGRATED FUSION SYSTEM
K133947 · OVD
X-Spine Systems, Inc.
Orthopedic · 218d
Cleared Jul 29, 2014
PEDILOC FRAGMENT SYSTEM
K140431 · HRS
OrthoPediatrics Corp.
Orthopedic · 159d
Cleared Jul 29, 2014
SKINTACT
K140500 · GEI
Leonhard Lang GmbH
General & Plastic Surgery · 152d
Cleared Jul 29, 2014
APERIO EPATHOLOGY EIHC IVD SYSTEM
K141109 · NOT
Leica Biosystems Imaging, Inc.
Pathology · 91d
Cleared Jul 29, 2014
CAMERA ENABLED PROBE
K141119 · HRX
Trice Medical, Inc.
Orthopedic · 90d
Cleared Jul 29, 2014
ZIMMER ZFX TITANIUM ABUTMENT FOR STRAUMANN BONE LEVEL IMPLANT SYSTEM
K141120 · NHA
Zimmer Dental, Inc.
Dental · 90d
Cleared Jul 29, 2014
VITALCONNECT PLATFORM (CONSISTING OF VITALCONNECT SENSOR, RELAY SOFTWARE...
K141167 · DRG
Vitalconnect, Inc.
Cardiovascular · 84d
Cleared Jul 29, 2014
CAREFINE PEN NEEDLE FAMILY INCLUDING QUINTAPOINT AND SUPERPOINT
K141749 · FMI
Facet Technologies, LLC
General Hospital · 29d
Cleared Jul 29, 2014
ALTEON 6.5MM BONE SCREWS
K141797 · LPH
Exactech, Inc.
Orthopedic · 27d
Cleared Jul 28, 2014
GENERICA MEDICAL ENTERNAL DELIVERY
K133077 · KNT
Generica Medical International, Inc.
Gastroenterology & Urology · 301d
Cleared Jul 28, 2014
OSTEOFAB PATIENT SPECIFIC FACIAL DEVICE
K133809 · KKY
Oxford Performance Materials
General & Plastic Surgery · 224d
Cleared Jul 28, 2014
HUMELOCK II CEMENTED SHOULDER SYSTEM
K140071 · KWT
Fx Solutions
Orthopedic · 196d
Cleared Jul 28, 2014
STOPSBLEEDING TOPICAL HEMOSTAT POWDER AND FOAM
K140313 · QSY
Coag Medical, LLC
General & Plastic Surgery · 168d
Cleared Jul 28, 2014
MR SYRINGE DUAL PACK
K140469 · DXT
Coeur, Inc.
Cardiovascular · 153d