FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
77641–77664 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Oct 26, 2001
OSTEOSET BVF KIT
K010532 · MQV
Wrightmedicaltechnologyinc
Orthopedic · 245d
Cleared Oct 26, 2001
AGILENT ELECTRONIC STETHOSCOPE, MODELS M4532A AND M4533A
K010729 · DQD
Andromed, Inc.
Cardiovascular · 228d
Cleared Oct 26, 2001
VITALSAT PULSE OXIMETER, MODEL IC32000
K011365 · DQA
Island Critical Care Corp.
Anesthesiology · 175d
Cleared Oct 26, 2001
SUN-TENS PALM TYPE R5/COMPACT WIRELES M2 EMS SERIES
K011913 · IPF
Sun-Rain System Corp.
Physical Medicine · 129d
Cleared Oct 26, 2001
INFINITY HBA KIT, MODELS 537-A, 537-B
K012410 · LCP
Sigma Diagnostics, Inc.
Hematology · 88d
Cleared Oct 26, 2001
CONFOSCAN 2 CONFOCAL MICROSCOPE
K012416 · HJO
Nidek Technologies Srl
Ophthalmic · 88d
Cleared Oct 26, 2001
DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM TEST SYSTEM
K012449 · MID
Diamedix Corp.
Immunology · 86d
Cleared Oct 26, 2001
DIAMEDIX IS-ANTI-CARDIOLIPIN IGA TEST SYSTEM
K012450 · MID
Diamedix Corp.
Immunology · 86d