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
71977–72000 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 30, 2003
FRESENIUS ULTRAFLUX HEMODIALYZER
K031378 · KDI
Fresenius Medical Care North America
Gastroenterology & Urology · 29d
Cleared May 30, 2003
M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.1
K031403 · MHX
Philips Medical Systems, Inc.
Cardiovascular · 25d
Cleared May 30, 2003
EXOJET TISSUE MANAGEMENT SYSTEM
K031406 · HRX
Mitek Worldwide
Orthopedic · 25d
Cleared May 30, 2003
SYNTHES (USA) STERNAL RECONSTRUCTION SYSTEM
K031508 · JDQ
Synthes (Usa)
Orthopedic · 16d
Cleared May 30, 2003
STARCAST DENTAL ALLOYS
K031543 · EJT
Star Refining Precious Metals South...
Dental · 14d
Cleared May 30, 2003
MYCOLOR 202 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS
K031552 · IYN
Medison America, Inc.
Radiology · 11d
Cleared May 29, 2003
CARECOMPANION PATIENT STATION & NURSE STATION
K022274 · DRG
Neptec Design Group, Ltd.
Cardiovascular · 318d
Cleared May 29, 2003
PACEART SYSTEM
K024278 · DPS
Medtronic Vascular
Cardiovascular · 157d
Cleared May 29, 2003
TOKUYAMA SOFRELINER TOUGH
K030663 · EBI
Tokuyama Dental Corporation
Dental · 87d
Cleared May 29, 2003
VERAVIEWEPOCS PANORAMIC/CEPHALOMETRIC X-RAY UNIT WITH CEPHALOMETRIC
K030699 · EAG
J. Morita Mfg. Corp.
Radiology · 84d
Cleared May 29, 2003
IPACS PRISM
K030751 · LLZ
Realtimeimage, Inc.
Radiology · 80d
Cleared May 29, 2003
KODAK DIRECTVIEW PACS/IMAGE MANAGEMENT SYSTEM, KODAK DIRECTVIEW WORKFLOW...
K030781 · LLZ
Eastman Kodak Company
Radiology · 79d
Cleared May 29, 2003
LIGASURE 5MM LAPAROSCOPIC SEALER-DIVIDER, MODEL LS1500
K031011 · GEI
Valleylab, Inc.
General & Plastic Surgery · 59d
Cleared May 29, 2003
PREMIER III PHASED ARRAY CTL SPINE COIL
K031139 · MOS
Usa Instruments, Inc.
Radiology · 49d
Cleared May 29, 2003
ALPHA 5000 WRIST COIL
K031143 · MOS
Usa Instruments, Inc.
Radiology · 49d
Cleared May 29, 2003
SPIRIT III TOTALSENSE CARDIAC COIL
K031172 · MOS
Usa Instruments, Inc.
Radiology · 45d
Cleared May 29, 2003
SAFIL AND SAFIL QUICK SYNTHETIC ABSORBABLE SURGICAL SUTURE
K031286 · GAM
Aesculap, Inc.
General & Plastic Surgery · 36d
Cleared May 29, 2003
THE PHILIPS INTELLIVUE MP60, MP70, AND MP90 PATIENT MONITORS, RELEASE A.20
K031481 · MHX
Philips Medizin Systeme Boblingen GmbH
Cardiovascular · 17d
Cleared May 28, 2003
WATER PURIFICATION SYSTEM
K022448 · FIP
Purity Water Company of San Antonio,...
Gastroenterology & Urology · 306d
Cleared May 28, 2003
PAPILLON MASK SET
K023068 · BZD
Map Medizintechnik Fur Arzt Und...
Anesthesiology · 254d
Cleared May 28, 2003
PROSONIC ULTRAVIOLET TOOTHBRUSH SANITIZER
K023662 · MCF
Hwadong International Company , Ltd.
Dental · 209d
Cleared May 28, 2003
ENCORE ANTERIOR SPINAL STAPLE SYSTEM
K030667 · KWQ
Encore Medical, L.P.
Orthopedic · 86d
Cleared May 28, 2003
IN-VISION IMAGING SYSTEM
K031148 · DXK
Jomed, Inc.
Cardiovascular · 48d
Cleared May 28, 2003
MODIFICATION TO ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR)
K031219 · HSB
Orthofix, Inc.
Orthopedic · 41d