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
74161–74184 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 11, 2002
AUDIOTRAVELLER, MODEL AA222
K022728 · ETY
Interacoustics A/S, Assens
Ear, Nose, Throat · 56d
Cleared Oct 11, 2002
SPIFE CK KIT, MODEL 3332, 3333
K022757 · JHY
Helena Laboratories
Chemistry · 52d
Cleared Oct 11, 2002
NITRILE POWDER-FREE EXAMINATION GLOVES
K022765 · LZA
Allegiance Healthcare Corp.
General Hospital · 52d
Cleared Oct 11, 2002
E-SPEED EBT SCANNER SYSTEM
K022794 · JAK
Ge Imatron
Radiology · 49d
Cleared Oct 11, 2002
COBRASCAN CR-1 FILMLESS
K022810 · LMA
Radiographic Digital Imaging, Inc.
Radiology · 49d
Cleared Oct 11, 2002
MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER
K022897 · GCJ
Computer Motion, Inc.
General & Plastic Surgery · 38d
Cleared Oct 11, 2002
IN-VISION VIEW WITH MEASUREMENTS MODULE, MODEL 1.0
K022940 · LLZ
Intelligent Images Srl
Radiology · 37d
Cleared Oct 11, 2002
ACUITY RADIATION THERAPY SIMULATOR
K023052 · KPQ
Varian Medical Systems, Inc.
Radiology · 28d
Cleared Oct 11, 2002
KONICA DIRECT DIGITIZER REGIUS, MODEL 170
K023061 · MQB
Konica Minolta Medical & Graphic, Inc.
Radiology · 25d
Cleared Oct 11, 2002
ACCUSKETCH CARDIAC QUANTITATIVE SYSTEM W/ ADVANCED ANALYSIS COMPONENTS
K023100 · LLZ
General Electric Medical Systems...
Radiology · 23d
Cleared Oct 11, 2002
ELOQUENCE, INTEGRATED FUNCTIONAL IMAGING SYSTEM
K023130 · LNH
Mri Devices Corp.
Radiology · 21d
Cleared Oct 11, 2002
VINYL EXAMINATION GLOVES, PRE-POWDERED
K023145 · LYZ
Shandong Jiazhan Plastic Products...
General Hospital · 21d
Cleared Oct 11, 2002
BBC-63-GE BREAST ARRAY COIL
K023164 · MOS
Mri Devices Corp.
Radiology · 18d
Cleared Oct 11, 2002
CONTACT LASER & DIAGNOSTIC LENSES
K023221 · HJK
Volk Optical, Inc.
Ophthalmic · 14d
Cleared Oct 10, 2002
AART SILICONE TUBING
K022306 · KGZ
Aesthetic and Reconstructive...
General & Plastic Surgery · 86d
Cleared Oct 10, 2002
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
K022316 · NLH
Vanguard Medical Concepts, Inc.
Cardiovascular · 85d
Cleared Oct 10, 2002
TWINKY STAR
K022797 · EBF
Voco GmbH
Dental · 48d
Cleared Oct 09, 2002
SMITH & NEPHEW SURETAC - EXPANDED INDICATIONS II
K020948 · JDR
Smith & Nephew, Inc.
Orthopedic · 198d
Cleared Oct 09, 2002
FRYE ADJUSTING INSTRUMENT
K021238 · LXM
Frye Health Systems
Physical Medicine · 174d
Cleared Oct 09, 2002
RITA SYSTEM
K021329 · GEI
Rita Medical Systems
General & Plastic Surgery · 166d
Cleared Oct 09, 2002
MYOCARDIAL LEAD IMPLANT TOOL, MODEL 10626
K022238 · DWS
Medtronic Vascular
Cardiovascular · 90d
Cleared Oct 09, 2002
STOCKERT V172-28 VENOUS FEMORAL CANNULA
K022321 · DWF
Stockert Instrumente GmbH
Cardiovascular · 84d
Cleared Oct 09, 2002
EZ-SCOPE AN, EZ-SCOPE LIGHT
K022342 · IYX
Anzai Medical Co., Ltd.
Radiology · 83d
Cleared Oct 09, 2002
PARATHYROID HORMONE TEST SYSTEM/NICHOLS ADVANTAGE QUICK-INTRAOPERATIVE...
K022472 · CEW
Nichols Institute Diagnostics
Chemistry · 75d