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
61369–61392 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 19, 2006
SUPERSTITCH 5F, 12F, AND EL
K062125 · GAW
Sutura, Inc.
General & Plastic Surgery · 86d
Cleared Oct 19, 2006
OPTIMEDICA LASER INDIRECT OPHTHALMOSCOPE
K062336 · GEX
Optimedica Corporation
General & Plastic Surgery · 70d
Cleared Oct 19, 2006
FRS SCREW
K062352 · HWC
DePuy Orthopaedics, Inc.
Orthopedic · 69d
Cleared Oct 19, 2006
K-SPRAY, MODEL 085-2715
K062418 · EFB
Scican
Dental · 62d
Cleared Oct 19, 2006
EBI OPTILOCK UPPER EXTREMITY PLATING SYSTEM
K062494 · HRS
Ebi, L.P.
Orthopedic · 55d
Cleared Oct 19, 2006
OSTEOPORE TCP
K062496 · MQV
Spinecraft, Inc.
Orthopedic · 55d
Cleared Oct 19, 2006
NEXUS 3
K062519 · EMA
Kerr Corporation
Dental · 52d
Cleared Oct 19, 2006
SYNTHES LCP DISTAL FEMUR PLATES
K062564 · HRS
Synthes (Usa)
Orthopedic · 49d
Cleared Oct 19, 2006
BELMONT BUDDY PLUS FLUID WARMER
K062774 · BSB
Belmont Instrument Corp.
Hematology · 31d
Cleared Oct 19, 2006
MODIFICATION TO LIFE SPINE NEO ANTERIOR CERVICAL PLATE SYSTEM
K062831 · KWQ
Life Spine
Orthopedic · 29d
Cleared Oct 19, 2006
MEDHOT MTI 2000 THERMAL IMAGING SYSTEM
K063047 · LHQ
Medhot Thermal Imaging, Inc.
Radiology · 15d
Cleared Oct 18, 2006
LIAISON EA IGG
K060204 · LSE
DiaSorin, Inc.
Microbiology · 265d
Cleared Oct 18, 2006
DENSHIELD TREATMENT FOR SENSITIVE TEETH
K061359 · LBH
Novamin Technology, Inc.
Dental · 155d
Cleared Oct 18, 2006
TORBOT VASCULAR COMPRESSION GARMENTS
K061411 · DWL
Torbut Group, Inc.
General Hospital · 149d
Cleared Oct 18, 2006
AMNIOSTAT-FLM-PG
K061549 · JHG
Irvine Scientific Sales Co., Inc.
Chemistry · 135d
Cleared Oct 18, 2006
STA CATH ATTACHABLE INFISION CATHETER, MODEL STA20
K061661 · MEB
Advanced Infusion, Inc.
General Hospital · 127d
Cleared Oct 18, 2006
QUANTA LITE PBC SCREEN IGG/IGA ELISA
K061842 · NRI
Inova Diagnostics, Inc.
Immunology · 111d
Cleared Oct 18, 2006
PORTEX EPIDURAL CATHETER
K062005 · BSO
Smiths Medical Asd, Inc.
Anesthesiology · 93d
Cleared Oct 18, 2006
RESUSCITATION TIMER, MODEL L770-CPR
K062080 · BTM
Allied Healthcare Products, Inc.
Anesthesiology · 89d
Cleared Oct 18, 2006
PRISMA SYSTEM R03.10A
K062090 · KDI
Gambro Renal Products
Gastroenterology & Urology · 86d
Cleared Oct 18, 2006
MASIMO SET SPO2 MODULE FOR PHILIPS AND M3001A MULTI-MEASUREMENT SERVER OPTION...
K062268 · DQA
Philips Medical Systems North America...
Anesthesiology · 72d
Cleared Oct 18, 2006
CLARITY MODIFIED CERAMIC BRACKETS
K062305 · NJM
3M Unitek
Dental · 71d
Cleared Oct 18, 2006
NASOPORE EAR, MODELS ND04, ND05
K062540 · KCN
Polyganics B.V.,
Ear, Nose, Throat · 49d
Cleared Oct 18, 2006
MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM
K062786 · NEZ
Given Imaging , Ltd.
Gastroenterology & Urology · 30d