FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
77257–77280 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 16, 2001
ENVIRON-NP POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES
K012499 · LYZ
Shanghai Antares Industries, Inc.
General Hospital · 74d
Cleared Oct 16, 2001
REVOTEK LC
K012542 · EBC
GC America, Inc.
Dental · 70d
Cleared Oct 16, 2001
POLY STAT HCG TEST
K012559 · JHI
Bion Diagnostic Sciences
Chemistry · 69d
Cleared Oct 16, 2001
THERMO TRACE AMMONIA STANDARDS SET, MODELS TR-609
K012878 · JIS
Thermo Dma, Inc.
Chemistry · 49d
Cleared Oct 16, 2001
ACCESS UNCONJUGATED ESTRIOL CALIBRATORS
K012900 · JIT
Beckman Coulter, Inc.
Chemistry · 48d
Cleared Oct 16, 2001
ALGO 3 NEWBORN HEARING SCREENER
K013137 · GWJ
Natus Medical, Inc.
Neurology · 27d
Cleared Oct 16, 2001
HRH-63-8 HEAD ARRAY COIL
K013159 · MOS
Mri Devices Corp.
Radiology · 25d
Cleared Oct 16, 2001
MODIFICATION TO: SENS-A-RAY SYSTEM WITH PROIMAGE SOFTWARE
K013176 · EHD
Afp Imaging Corp.
Radiology · 22d
Cleared Oct 16, 2001
MODIFIED INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM
K013215 · BXM
Nuvasive, Inc.
Anesthesiology · 20d
Cleared Oct 16, 2001
MODIFICATION TO SYNCHRON CONTROL
K013235 · JJY
Beckman Coulter, Inc.
Chemistry · 18d
Cleared Oct 16, 2001
HAC-420 HEAD ARRAY COIL
K013322 · MOS
Mri Devices Corp.
Radiology · 11d
Cleared Oct 15, 2001
TORAYSULFONE DIALYZER
K002512 · KDI
Toray Industries (America), Inc.
Gastroenterology & Urology · 426d
Cleared Oct 15, 2001
PAM-RL
K010997 · GWQ
Individual Monitoring Systems, Inc.
Neurology · 195d
Cleared Oct 15, 2001
MONOJECT PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE
K011283 · NGT
The Kendall Company
General Hospital · 171d
Cleared Oct 15, 2001
MERTEX-PLUS REUSABLE SURGICAL DRAPE
K012237 · KKX
Mercan AB
General Hospital · 90d
Cleared Oct 15, 2001
MERTEX-PLUS O.R./SURGEONS GOWN, NONSTERILE
K012240 · FYA
Mercan AB
General Hospital · 90d
Cleared Oct 15, 2001
CHIBA NEEDLE
K012358 · FCG
Ispg, Inc.
Gastroenterology & Urology · 82d
Cleared Oct 15, 2001
EAR MUFFINS
K012384 · HCC
Bio-Logic Systems Corp.
Neurology · 80d
Cleared Oct 15, 2001
ACON MTD ONE STEP METHADONE TEST STRIP AND TEST DEVICE
K012595 · DJR
ACON Laboratories, Inc.
Toxicology · 66d
Cleared Oct 15, 2001
FAS ENDOLUMINAL BRUSH
K012641 · LJS
Fas Medical , Ltd.
General Hospital · 63d
Cleared Oct 15, 2001
RAICHEM BUN RATE REAGENT
K012649 · CDQ
Hemagen Diagnostics, Inc.
Chemistry · 63d
Cleared Oct 15, 2001
RAICHEM GLUCOSE UV REAGENT
K012668 · CFR
Hemagen Diagnostics, Inc.
Chemistry · 63d
Cleared Oct 15, 2001
POWDERED LATEX EXAMINATION GLOVES
K013026 · LYY
Great Glove (Thailand) Co. , Ltd.
General Hospital · 35d
Cleared Oct 15, 2001
MODIFICATION TO ALPHA DX SYSTEM
K013118 · JHX
First Medical, Inc.
Chemistry · 27d