Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
74785–74808 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Oct 09, 2002
W-5
K022811 · EJT
Ivoclar Vivadent, Inc.
Dental · 47d
Cleared Oct 09, 2002
CLEAR-IT ANTI-FOG, MODEL PS003
K022826 · OCT
Preservation Solutions, Inc.
Gastroenterology & Urology · 44d
Cleared Oct 09, 2002
VITA IN-CERAM YZ CUBES FOR CEREC
K022996 · EIH
Vident
Dental · 30d
Cleared Oct 09, 2002
ACCOLADE TMZF PLUS HA 127 SIZE 0 HIP STEM
K023102 · MEH
Howmedica Osteonics Corp.
Orthopedic · 21d
Cleared Oct 09, 2002
JET-X TIN COATED HALF PINS
K023134 · JDW
Smith & Nephew, Inc.
Orthopedic · 19d
Cleared Oct 09, 2002
NITRILE POWDER-FREE EXAMINATION GLOVES
K023170 · LZA
Allegiance Healthcare Corp.
General Hospital · 16d
Cleared Oct 09, 2002
OPART (INCLUDING OPART ULTRA AND ULTRA GRADIENT UPGRADE KIT)
K023207 · LNH
Toshiba America Medical Systems, In.C
Radiology · 14d