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
78241–78264 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 31, 2001
MODIFICATION TO: ECAT LSO PET/CT SCANNER
K013504 · KPS
Cti Pet Systems, Inc.
Radiology · 9d
Cleared Oct 30, 2001
PALAMED BONE CEMENT
K010586 · LOD
Merck Biomaterial GmbH
Orthopedic · 245d
Cleared Oct 30, 2001
ULTRASOUND TRANSDUCER COVER
K011265 · ITX
Advance Medical Designs, Inc.
Radiology · 188d
Cleared Oct 30, 2001
SOVEREIGN
K011476 · INI
Shoprider Intl., Inc.
Physical Medicine · 169d
Cleared Oct 30, 2001
CRYO-HIT, MODELS EP6T5, FP5T5, FP5T3, EP2T2, EP1T1, AND EP2T1
K012497 · GEH
Galil Medical , Ltd.
General & Plastic Surgery · 88d
Cleared Oct 30, 2001
SEPRAGEL SINUS
K012532 · LYA
Genzyme Corp.
Ear, Nose, Throat · 85d
Cleared Oct 30, 2001
VANGUARD REPROCESSED ARTHROSCOPIC WANDS
K012695 · GEI
Vanguard Medical Concepts, Inc.
General & Plastic Surgery · 77d
Cleared Oct 30, 2001
HEAMOPHILUS/STREPTOCOCCUS PNEUMONIAE
K012895 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 63d
Cleared Oct 30, 2001
TM2000 EASYTRACE PLUS RECEIVING CENTER
K013175 · DXH
Card Guard Scientific Survival , Ltd.
Cardiovascular · 36d
Cleared Oct 30, 2001
HEMI-ARC SURGICAL NAVIGATOR
K013257 · HAW
Nuvasive, Inc.
Neurology · 29d
Cleared Oct 30, 2001
LIFEJET VIDEO LINK
K013395 · LMA
Ferrania S.P.A.
Radiology · 15d
Cleared Oct 30, 2001
CARDIQ FUNCTION
K013422 · JAK
GE Medical Systems
Radiology · 15d
Cleared Oct 29, 2001
CW DISPOSABLE ACUPUNCTURE NEEDLE
K011248 · MQX
Acusupply, Inc.
General Hospital · 189d
Cleared Oct 29, 2001
MICROPLEX COIL SYSTEM
K012145 · HCG
MicroVention, Inc.
Neurology · 111d
Cleared Oct 29, 2001
THEKEN LARGE CEMENT RESTRICTOR
K012462 · JDK
Theken Surgical,Llc
Orthopedic · 89d
Cleared Oct 29, 2001
MULTITAK SPLINTER 3.0 MM RESORBABLE ANCHOR
K012465 · MAI
Bonutti Research, Inc.
Orthopedic · 89d
Cleared Oct 29, 2001
APEX MEDICAL LCD TENS-VII
K012643 · GZJ
Apex Medical Corp.
Neurology · 77d
Cleared Oct 29, 2001
MICROMEDICS FIBRIJET AEROSOL APPLICATOR
K012868 · FMF
Micromedics, Inc.
General Hospital · 63d
Cleared Oct 29, 2001
FUJI VII CAPSULE
K013198 · EMA
GC America, Inc.
Dental · 34d
Cleared Oct 29, 2001
XANTALGIN CRONO
K013336 · ELW
Cavex Holland BV
Dental · 20d
Cleared Oct 29, 2001
BELLEGLASS HP OPAQUE 2
K013375 · EBF
Kerr Dental Materials Center
Dental · 18d
Cleared Oct 29, 2001
CRANIAL HELMET
K013458 · MVA
Children'S Hospital
Neurology · 11d
Cleared Oct 26, 2001
STOCKERT V172 SERIES VENOUS FEMORAL CANNULAE
K001509 · DWF
Cobe Cardiovascular, Inc.
Cardiovascular · 529d
Cleared Oct 26, 2001
BIOPATCH ANTIMICROBIAL DRESSING
K003229 · SEL
Integra Lifesciences Corp.
General & Plastic Surgery · 381d