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
70321–70344 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 12, 2003
BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S500
K033239 · INI
Tung Keng Enterprise Co., Ltd.
Physical Medicine · 37d
Cleared Nov 12, 2003
MODIFICATION TO DASH 3000/4000 PATIENT MONITOR
K033304 · MHX
Ge Medical Systems Information...
Cardiovascular · 29d
Cleared Nov 12, 2003
MODIFICATION TO: HI-ART SYSTEM
K033347 · IYE
Tomotherapy Incorporated
Radiology · 23d
Cleared Nov 12, 2003
BESTALOY
K033434 · EJJ
We Dong Myung Dental Industrial Co.,...
Dental · 15d
Cleared Nov 12, 2003
E-SARANG 86, DM78, DM55
K033435 · EJT
We Dong Myung Dental Industrial Co.,...
Dental · 15d
Cleared Nov 10, 2003
POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINES...
K030583 · LYY
Shen Wei (Usa), Inc.
General Hospital · 259d
Cleared Nov 10, 2003
ANZAI AZ-733 RESPIRATORY GATING SYSTEM
K031385 · LHN
Anzai Medical Co., Ltd.
Radiology · 193d
Cleared Nov 10, 2003
RELIANT LASER SYSTEM
K031795 · GEX
Reliant Technologies, Inc.
General & Plastic Surgery · 153d
Cleared Nov 10, 2003
XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY
K031834 · MHI
Remel, Inc.
Microbiology · 150d
Cleared Nov 10, 2003
BLOOD PRESSURE MONITOR, MODEL M100
K032308 · DXN
Meditek Technology, Inc.
Cardiovascular · 108d
Cleared Nov 10, 2003
SOMATON COMPUTED TOMOGRAPHY X-RAY SYSTEMS SLIDING GANTRY OPTION
K032475 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 90d
Cleared Nov 10, 2003
SOMATOM EXTENDED FIELD OF VIEW SOFTWARE OPTION
K032536 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 84d
Cleared Nov 10, 2003
POWERPRO PNEUMATIC SYSTEM, MODELS PRO6150, PRO6175, PRO6185
K032607 · DZI
Linvatec Corp.
Dental · 77d
Cleared Nov 10, 2003
MEDICHEART, MODEL RELEASE 1
K032823 · JAK
Medicsight
Radiology · 61d
Cleared Nov 10, 2003
STAR (LUNAR SERIES) MONITORING SYSTEM
K032867 · MWI
Larsen & Toubro Limited
Cardiovascular · 56d
Cleared Nov 10, 2003
PLANET MONITORING SYSTEM
K032871 · MWI
Larsen & Toubro Limited
Cardiovascular · 56d
Cleared Nov 10, 2003
SUMMIT STAIRWAY LIFT
K032880 · ILK
Summit Lifts, Inc.
Physical Medicine · 56d
Cleared Nov 10, 2003
WU'S 3-WHEELED NEO SCOOTER, MODEL WT-M3JR
K033032 · INI
Wu'S Tech Co., Ltd.
Physical Medicine · 45d
Cleared Nov 10, 2003
BE-MOBILE 3-WHEELED ELECTRIC SCOOTER, MODEL DK S320
K033241 · INI
Tung Keng Enterprise Co., Ltd.
Physical Medicine · 35d
Cleared Nov 10, 2003
PROFILE -ER
K033334 · DIS
Medtox Diagnostics, Inc.
Toxicology · 25d
Cleared Nov 10, 2003
ABSOLUTE .035 SELF-EXPANDING BILIARY STENT SYSTEM
K033393 · FGE
Guidant Corp.
Gastroenterology & Urology · 18d
Cleared Nov 10, 2003
TSX-101A/A AND TSX-101A/C AQUILION MULTISLICE CT SCANNERS
K033418 · JAK
Toshiba America Medical Systems, In.C
Radiology · 14d
Cleared Nov 10, 2003
MODIFICATION TO EN-BLOC BIOPSY SYSTEM
K033427 · KNW
Neothermia Corp.
Gastroenterology & Urology · 13d
Cleared Nov 07, 2003
PANAVIA F 2.0
K032455 · EMA
Kuraray Medical, Inc.
Dental · 88d