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
73657–73680 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Oct 09, 2002
SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SYSTEM, MODELS...
K022489 · CAC
Summit Medical , Ltd.
Anesthesiology · 72d
Cleared Oct 09, 2002
BACTON DICKINSON LATITUDE BLOOD GLUCOSE MONITORING SYSTEM
K022580 · CGA
Becton, Dickinson & CO
Chemistry · 65d
Cleared Oct 09, 2002
BECTON DICKINSON LOGIC BLOOD GLUCOSE MONITORING SYSTEM
K022581 · NBW
Becton, Dickinson & CO
Chemistry · 65d
Cleared Oct 09, 2002
MODIFICATION TO FOCUS
K022630 · EHD
Instrumentarium Corp.
Radiology · 63d
Cleared Oct 09, 2002
POROUS HDPE SURGICAL IMPLANTS, TO BE DISTRIBUTED UNDER VARIOUS TRADEMARKS...
K022665 · KKY
Hohenstein Enterprises, Inc.
General & Plastic Surgery · 61d
Cleared Oct 09, 2002
PDO (POLYDIOXANONE) MONOFILAMENT SYNTHETIC ABSORBABLE SUTURE U.S.P.
K022666 · NEW
Arc Medical Supplies (Beijing) Co, Ltd.
General & Plastic Surgery · 61d
Cleared Oct 09, 2002
REPROCESSED DISPOSABLE TROCARS
K022743 · KAB
Medical Device Services
Ear, Nose, Throat · 51d
Cleared Oct 09, 2002
REPROCSSED USED DISPOSABLE ENDOSCOPIC SCISSORS AND GRASPERS
K022748 · HET
Medical Device Services
Obstetrics & Gynecology · 51d
Cleared Oct 09, 2002
EPOCH XP NEUROLOGICAL WORKSTATION
K022785 · GWQ
Axon Systems, Inc.
Neurology · 48d