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
69601–69624 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 02, 2003
CAP3 BONE SUBSTITUTE MATERIAL
K033138 · MQV
Etex Corp.
Orthopedic · 63d
Cleared Dec 02, 2003
LA500 BLUE LIGHT
K033201 · EBZ
Apoza Enterprise Co., Ltd.
Dental · 61d
Cleared Dec 02, 2003
PRECISET DAT THC AND PRECISET DAT THC 20 CALIBRATORS
K033246 · DLJ
Roche Diagnostics Corp.
Toxicology · 56d
Cleared Dec 02, 2003
QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945
K033387 · JJY
Bio-Rad
Chemistry · 40d
Cleared Dec 02, 2003
PFZ PORCELAIN SYSTEM
K033553 · EIH
Dentsply Intl.
Dental · 22d
Cleared Dec 01, 2003
MULTI-STRAP FULL FACE MASK
K023683 · BZD
Engineered Medical Systems
Anesthesiology · 395d
Cleared Dec 01, 2003
MICROLAB SPIROMETER
K031102 · BZG
Micro Direct, Inc.
Anesthesiology · 238d
Cleared Dec 01, 2003
POLARIS WR
K031671 · GEX
Syneron Medical, Ltd.
General & Plastic Surgery · 186d
Cleared Dec 01, 2003
AUTO SUTURE ENDOSCOPIC (& OPEN) TA SURGICAL STAPLER, AUTO SUTURE ENDOSCOPIC...
K032696 · GDW
United States Surgical, A Division of...
General & Plastic Surgery · 90d
Cleared Nov 28, 2003
BESMED VARIOUS MODELS OF TENS, BE-550/BE-660
K031374 · GZJ
Besmed Health Business Corp
Neurology · 212d
Cleared Nov 28, 2003
TRIHA +
K031826 · MQV
Teknimed, S.A.
Orthopedic · 168d
Cleared Nov 28, 2003
MULTICLEAR MULTIWAVELENGTH TARGETED PHOTOTHERAPY SYSTEM
K032383 · GEX
Curelight, Ltd.
General & Plastic Surgery · 119d
Cleared Nov 28, 2003
PORTEX THERMOVENT HEPA HME BREATHING FILTER WITH CO2 PORT (STERILE AND...
K032716 · CAH
Portex , Ltd.
General Hospital · 87d
Cleared Nov 28, 2003
GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
K032865 · FTL
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 77d
Cleared Nov 28, 2003
MICRUS MICROCOIL SYSTEM
K032872 · HCG
Micrus Corp.
Neurology · 74d
Cleared Nov 28, 2003
POWERED WHEELCHAIR, MODEL FR168W
K033370 · ITI
Freerider Corp
Physical Medicine · 38d
Cleared Nov 28, 2003
CWAS 1000
K033452 · IKN
Fasstech
Neurology · 29d
Cleared Nov 28, 2003
MALIS IRRIGATION MODULE 1000
K033499 · GEI
Valley Forge Scientific Corp.
General & Plastic Surgery · 23d
Cleared Nov 28, 2003
MODIFICATION TO VERSABOND BONE CEMENT
K033509 · LOD
Smith & Nephew, Inc.
Orthopedic · 22d
Cleared Nov 28, 2003
ARTHROCARE ARTHROWANDS
K033584 · GEI
Arthrocare Corp.
General & Plastic Surgery · 15d
Cleared Nov 26, 2003
OPTIMESH
K014200 · EZX
Spineology, Inc.
General & Plastic Surgery · 705d
Cleared Nov 26, 2003
ORTHOSPHERE CERAMIC SPHERICAL IMPLANT
K030319 · KWD
Wrightmedicaltechnologyinc
Orthopedic · 300d
Cleared Nov 26, 2003
CONSULTIVA CASE INPUT STATION, MODEL CIS-1
K031132 · LLZ
Eastman Kodak Company
Radiology · 231d
Cleared Nov 26, 2003
GAMMAMED PLUS 3/24 HDR REMOTE AFTERLOADER
K031524 · JAQ
Varian Medical Systems, Inc.
Radiology · 195d