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
69817–69840 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Nov 07, 2003
DEKOMPRESSOR PERCUTANEOUS DISCECTOMY PROBE
K032473 · HRX
Stryker Instruments
Orthopedic · 87d
Cleared Nov 07, 2003
ALOETOUCH POWDER FREE NEOPRENE SURGICAL GLOVES, STERILE, TURQUOISE COLOUR AND...
K032647 · KGO
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 72d
Cleared Nov 07, 2003
DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414)
K032697 · JIS
Dade Behring, Inc.
Chemistry · 66d
Cleared Nov 07, 2003
PROCLEAR COMPATIBLES MULTIFOCAL
K032873 · LPL
CooperVision, Inc.
Ophthalmic · 53d
Cleared Nov 07, 2003
CALIBRATING MATERIAL, ISE ELECTROLYTE REFERENCE
K033061 · JIX
Diamond Diagnostics, Inc.
Chemistry · 39d
Cleared Nov 07, 2003
DGH 55 HANDHELD PACHYMETER (PACHMATE)
K033385 · IYO
Dgh Technology, Inc.
Radiology · 15d
Cleared Nov 07, 2003
3I TG OSSEOTITE IMPLANT, MODELS TG685, TG610, TG611, TG613, TG5685, TG5610,...
K033430 · DZE
Implant Innovations, Inc.
Dental · 10d
Cleared Nov 06, 2003
KD-726 MEMORY WRIST AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K030359 · DXN
Kodon(Tianjin)Electronic&Electrical...
Cardiovascular · 276d
Cleared Nov 06, 2003
VITERION 100 TELEHEALTH MONITOR
K030419 · MWI
Viterion Telehealthcare, LLC
Cardiovascular · 269d