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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
69361–69384 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 02, 2003
SMITH & NEPHEW IUR MORCELLATION SYSTEM
K031787 · HIH
Smith & Nephew, Inc.
Obstetrics & Gynecology · 175d
Cleared Dec 02, 2003
WU'S 3-WHEELED NEO SCOOTER, WT-T3D
K032488 · INI
Wu'S Tech Co., Ltd.
Physical Medicine · 112d
Cleared Dec 02, 2003
JUSTWIN SCOOTER, JS-3013
K032643 · INI
Joy Ride Tech Co., Ltd.
Physical Medicine · 97d
Cleared Dec 02, 2003
JUSTWIN SCOOTER, JS-3014
K032645 · INI
Joy Ride Tech Co., Ltd.
Physical Medicine · 97d
Cleared Dec 02, 2003
XIO RADIATION TREATMENT PLANNING SYSTEM
K032762 · IYE
Computerized Medical Systems, Inc.
Radiology · 88d
Cleared Dec 02, 2003
STRYKER MINI-MENDER MENISCAL REPAIR SYSTEM
K032901 · GAT
Stryker Endoscopy
General & Plastic Surgery · 76d
Cleared Dec 02, 2003
TRSANSDERM IONTO SYSTEM
K032968 · EGJ
Mattioli Engineering Corp.
Physical Medicine · 70d
Cleared Dec 02, 2003
TAIWAN KING STRONG TC 03 MECHANICAL WHEELCHAIR
K033031 · IOR
Taiwan King Strong Co., Ltd.
Physical Medicine · 67d
Cleared Dec 02, 2003
TAIWAN KING STRONG POWERED WHEELCHAIR, TP 01
K033100 · ITI
Taiwan King Strong Co., Ltd.
Physical Medicine · 64d
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