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
66529–66552 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 09, 2005
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
K042074 · NLH
Vanguard Medical Concepts, Inc.
Cardiovascular · 219d
Cleared Mar 09, 2005
TUNG FU AIRMATE TENS, VITALITY MODE, TF-DT001
K042107 · GZJ
Tung FU Electric Co., Ltd.
Neurology · 217d
Cleared Mar 09, 2005
DIASYS INTEGRA II
K042109 · DXN
Novacor France
Cardiovascular · 216d
Cleared Mar 09, 2005
WRO 300 WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
K042797 · FIP
Gambro Renal Products
Gastroenterology & Urology · 152d
Cleared Mar 09, 2005
AURA CPAP SYSTEM
K042945 · BZD
Aeiomed, Inc.
Anesthesiology · 135d
Cleared Mar 09, 2005
POWDERED YELLOW SYNTHETIC VINYL EXAMINATION GLOVES, SMALL, MEDIUM, LARGE,...
K043478 · LYZ
Shijaizhuang Brilliant Ocean Plastic...
General Hospital · 83d
Cleared Mar 09, 2005
MENTOR ARIS TRANS-OBTURATOR TAPE AND SURGICAL KIT
K050148 · OTN
Mentor Corporation
Gastroenterology & Urology · 44d
Cleared Mar 09, 2005
SHARPOINT LUKENS BONE WAX
K050292 · MTJ
Surgical Specialties Corp
General & Plastic Surgery · 30d
Cleared Mar 09, 2005
SIS FISTULA PLUG
K050337 · FTM
Cook Biotech, Inc.
General & Plastic Surgery · 27d
Cleared Mar 09, 2005
PERMACOL SURGICAL IMPLANT T-PIECE, PERMACOL SURGICAL IMPLANT RECTOCELE-PIECE,...
K050355 · PAI
Tissue Science Laboratories, Plc
Obstetrics & Gynecology · 23d
Cleared Mar 09, 2005
MALIS 2000 BIPOLAR ELECTROSURGICAL SYSTEM
K050364 · GEI
Valley Forge Scientific Corp.
General & Plastic Surgery · 23d
Cleared Mar 09, 2005
AURORA SR AND SRA APPLICATOR
K050452 · GEX
Syneron Medical, Ltd.
General & Plastic Surgery · 15d
Cleared Mar 08, 2005
ARCOMXL POLYETHYLENE LINERS
K042051 · LPH
Biomet, Inc.
Orthopedic · 221d
Cleared Mar 08, 2005
YIXIN SAFETY SYRINGE
K042102 · MEG
Jiangxi Sanxin (Eversincere) Medical...
General Hospital · 216d
Cleared Mar 08, 2005
PREVENTION BREATHABLE, IMPERVIOUS SURGICAL GOWNS
K043017 · FYA
Medline Industries, Inc.
General Hospital · 126d
Cleared Mar 08, 2005
DRAGON HEART I.V. SET
K043235 · FPA
Dragon Heart Medical Devices Co., Ltd.
General Hospital · 106d
Cleared Mar 08, 2005
MEDLINE SURGICAL GOWNS
K043585 · FYA
Medline Industries, Inc.
General Hospital · 70d
Cleared Mar 08, 2005
SMARXT BMR 1900 CLOSED VENOUS RESERVOIR BAG
K050111 · DTN
Cobe Cardiovascular, Inc.
Cardiovascular · 49d
Cleared Mar 08, 2005
FX WIRE ADVANCED MEASUREMENT GUIDEWIRE
K050304 · OCY
Conmedcorp
Gastroenterology & Urology · 28d
Cleared Mar 08, 2005
PERFORMA ADULT HOLLOW FIBER MEMBRANE OXYGENATOR
K050447 · DTZ
Dideco S.R.L.
Cardiovascular · 14d
Cleared Mar 07, 2005
CLEVER CHEK TD-3213
K042795 · NBW
Taidoc Technology Corporation
Chemistry · 151d
Cleared Mar 07, 2005
NEXGEN COMPLETE KNEE SOLUTION MIS TIBIAL COMPONENTS, LOCKING SCREW AND STEM...
K043101 · JWH
Zimmer, Inc.
Orthopedic · 118d
Cleared Mar 07, 2005
NEO IMPLANT SYSTEM
K043195 · DZE
Neoss, Ltd.
Dental · 109d
Cleared Mar 07, 2005
AUTOSTAT II ANTI-TISSUE TRANSGLUTAMINASE IGG ELISA
K043433 · MVM
Hycor Biomedical , Ltd.
Immunology · 84d