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
84937–84960 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 24, 1999
BIOCHECK FERRITIN ELISA MODEL BC-1025
K992517 · DBF
Biocheck, Inc.
Immunology · 58d
Cleared Sep 24, 1999
FLEXIBLE NASOPHARYNGO-LARYNGOSCOPES, FLEXIBLE BRONCHOSCOPE
K992526 · EOB
Richard Wolf Medical Instruments Corp.
Ear, Nose, Throat · 58d
Cleared Sep 24, 1999
NTERO RF SLEEVE
K992572 · GEI
Ntero Surgical, Inc.
General & Plastic Surgery · 53d
Cleared Sep 24, 1999
A-15 HEMODIALYZER
K992594 · FJI
Althin Medical AB
Gastroenterology & Urology · 52d
Cleared Sep 24, 1999
QTEXX PRE-POWDERED NITRILE EXAMINATION GLOVES
K992671 · LZA
Latexx Partners Bhd.
General Hospital · 45d
Cleared Sep 24, 1999
DISPOSABLE POWDER FREE NITRILE EXAM GLOVE, BLUE COLOR
K992686 · LZA
Sheen More Ent. Co., Ltd.
General Hospital · 45d
Cleared Sep 24, 1999
MILLENIUM MICROKERATOME, MODEL IMD-001
K992687 · HMY
Industrial & Medical Design, Inc.
Ophthalmic · 45d
Cleared Sep 24, 1999
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, WHITE COLOR
K992860 · LYZ
Shijiazhuang Hongray Plastic Products...
General Hospital · 30d
Cleared Sep 24, 1999
VAPR 2.3 MM SIDE EFFECT ELECTRODE FOR USE WITH VAPR SYSTEM
K992876 · HRX
Mitek Products
Orthopedic · 29d
Cleared Sep 24, 1999
LEKSELL IMAGE GUIDANCE SURGICAL SYSTEM, VIEW SCOPE, SURGISCOPE,ELEKTA INSIGHT
K992882 · HAW
Elekta Instrument AB
Neurology · 29d
Cleared Sep 24, 1999
RENEW RECEIVER
K992946 · GZB
Advanced Neuromodulation Systems
Neurology · 23d
Cleared Sep 24, 1999
ARTHROCARE SYSTEM 2000 CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD,...
K992972 · GEI
Arthrocare Corp.
General & Plastic Surgery · 21d
Cleared Sep 24, 1999
ELECSYS ESTRADIOL CALSET II
K992981 · JIT
Roche Diagnostics Corp.
Chemistry · 21d
Cleared Sep 24, 1999
SALTER LABS SINGLE PATIENT USE EXHALATION AEROSOL FILTER
K992986 · CAF
Salter Labs
Anesthesiology · 21d
Cleared Sep 24, 1999
PRESTIGE LX BLOOD GLUCOSE TEST SYSTEM
K992988 · CGA
Home Diagnostics, Inc.
Chemistry · 21d
Cleared Sep 23, 1999
E100M VENTILATOR (E100M)
K972833 · CBK
Newport Medical Instruments, Inc.
Anesthesiology · 785d
Cleared Sep 23, 1999
ACCUIMAGE, ACCUVIEW DIAGNOSTIC IMAGING, WORKSTATION W/ACCUSCORE, ACCUANALYZE,...
K990241 · LLZ
Accuimage Diagnostics Corp.
Radiology · 241d
Cleared Sep 23, 1999
NMT NEUROSCIENCES CONTROL UNIT, MODEL 910-600 & NMT NEUROSCIENCES DISPOSABLE...
K990660 · JXG
Nmt Neurosciences Implants S.A.
Neurology · 206d
Cleared Sep 23, 1999
PERIMED TRANSCUTANEOUS PO2 AND PCO2 MONITOR (PF5040)
K990960 · LKD
Perimed, Inc.
Anesthesiology · 185d
Cleared Sep 23, 1999
VACUTAINER BRAND SODIUM CITRATE PEDIATRIC TUBE
K991551 · JKA
Bd Becton Dickinson Vacutainer...
Chemistry · 143d
Cleared Sep 23, 1999
AGILITY STEERABLE GUIDEWIRE
K991646 · DQX
Cordis Neurovascular, Inc.
Cardiovascular · 133d
Cleared Sep 23, 1999
SORING GMBH, SONOCA 300
K992026 · BTA
Soring GmbH Medizintechnik
General & Plastic Surgery · 99d
Cleared Sep 23, 1999
PE-PLUS ACETABULAR CUP
K992153 · JDI
Plus Orthopedics
Orthopedic · 90d
Cleared Sep 23, 1999
SURGISIS SLING
K992159 · PAG
Cook Biotech, Inc.
General & Plastic Surgery · 90d