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
77761–77784 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 17, 2001
VANGUARD REPROCESSED COMPRESSION GARMENT
K012403 · JOW
Vanguard Medical Concepts, Inc.
Cardiovascular · 79d
Cleared Oct 17, 2001
SONICATOR PLUS 930, MODEL ME 930
K013192 · IMI
Mettler Electronics Corp.
Physical Medicine · 22d
Cleared Oct 17, 2001
LUXABITE
K013236 · ELW
Dmg USA, Inc.
Dental · 19d
Cleared Oct 16, 2001
ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY (RPFA)
K011337 · JOZ
Accumetrics, Inc.
Hematology · 167d
Cleared Oct 16, 2001
VERTRAN STANDING WHEELCHAIR
K011530 · IPL
Fena Design, Inc.
Physical Medicine · 152d
Cleared Oct 16, 2001
VBR
K012254 · MQP
Osteotech, Inc.
Orthopedic · 90d
Cleared Oct 16, 2001
ENVIORN-NP POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES, YELLOW
K012339 · LYZ
Shanghai Antares Industries, Inc.
General Hospital · 84d
Cleared Oct 16, 2001
VANGUARD REPROCESSED ARTHROSCOPIC BLADES
K012346 · HRX
Vanguard Medical Concepts, Inc.
Orthopedic · 84d
Cleared Oct 16, 2001
STORZ MODULITH SLK LITHOTRIPTER WITH MULTIVIEW OPTION
K012482 · LNS
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 75d
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