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

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176,076 results
66385–66408 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 24, 2005
ALLIGATOR RETRIEVAL DEVICE (ARD)
K043580 · DQY
Chestnut Medical Technologies, Inc.
Cardiovascular · 86d
Cleared Mar 24, 2005
Q-SWITCHED ND:YAG OPHTALMIC LASER (WITH SLIT LAMP), MODEL OPTIMIS II
K043613 · HQF
Quantel Medical
Ophthalmic · 84d
Cleared Mar 24, 2005
HENKE SASS WOLF OF AMERICA BARIATRIC LAPAROSCOPE
K050163 · GCJ
Henke Sass Wolf of America, Inc.
General & Plastic Surgery · 58d
Cleared Mar 24, 2005
CRYOMEDICAL INSTRUMENTS CRYO-PAC SYSTEMS
K050272 · GXH
Cryomedical Instruments, Ltd.
Neurology · 48d
Cleared Mar 24, 2005
MRIDIUM 3850 MRI PUMP SYSTEM
K050301 · FRN
Iradimed Corporation
General Hospital · 44d
Cleared Mar 24, 2005
ADHESIVE 1
K050331 · KLE
Southern Dental Industries, Inc.
Dental · 42d
Cleared Mar 24, 2005
CD HORIZON SPINAL SYSTEM
K050439 · NKB
Medtronic Sofamor Danek, Inc.
Orthopedic · 30d
Cleared Mar 24, 2005
AOC BONE WAX, OSTENE, OSTEOTENE, ORTHOSEAL, OSTEOSEAL, CERETENE, MODEL BW-12
K050440 · MTJ
Ceremed , Inc.
General & Plastic Surgery · 30d
Cleared Mar 24, 2005
SYNTHES VECTRA SYSTEM
K050451 · KWQ
Synthes Spine Co.Lp
Orthopedic · 30d
Cleared Mar 24, 2005
4D INTEGRATED TREATMENT CONSOLE
K050479 · IYE
Varian Medical Systems
Radiology · 28d
Cleared Mar 24, 2005
QUEST DIAGNOSTICS IMMUNOASSAY/TDM CONTROL
K050536 · JJY
Bio-Rad
Chemistry · 22d
Cleared Mar 24, 2005
MEGA POWER ELECTROSURGICAL GENERATOR
K050579 · GEI
Megadyne Medical Products, Inc.
General & Plastic Surgery · 17d
Cleared Mar 23, 2005
TRIACTIV SYSTEM
K042040 · NFA
Kensey Nash Corp.
Cardiovascular · 237d
Cleared Mar 23, 2005
ONEFLOW FVC, ONEFLOW FVC (KIT), ONEFLOW FVC SCREEN
K042058 · BZG
Clement Clarke Intl., Ltd.
Anesthesiology · 236d
Cleared Mar 23, 2005
14F DUAL FLOATING DIALYSIS CATHETER/TRAY
K042672 · MSD
Cardio Med Supplies, Inc.
Gastroenterology & Urology · 175d
Cleared Mar 23, 2005
TITAN DENTAL IMPLANT ATTACHMENT
K042715 · NHA
Titan Implants, Inc.
Dental · 174d
Cleared Mar 23, 2005
DIALYSIS SERVICES WATER TREATMENT & DISTRIBUTION SYSTEM
K043344 · FIP
Dialysis Services, Inc.
Gastroenterology & Urology · 107d
Cleared Mar 23, 2005
REPROCESSED EP TECHNOLOGIES ELECTROPHYSIOLOGY CATHETERS
K043393 · NLH
Alliance Medical Corp.
Cardiovascular · 103d
Cleared Mar 23, 2005
IQ 200 URINE ANALYZER BODY FLUIDS MODULE
K050235 · GKL
Iris International, Inc.
Hematology · 50d
Cleared Mar 23, 2005
MILLENNIUM MULTI-LEAF COLLIMATOR
K050442 · IYE
Varian Medical Systems
Radiology · 29d
Cleared Mar 23, 2005
MODIFICATION TO RAVEN BACTERIAL SPORE STRIPS
K050591 · FRC
Raven Biological Laboratories, Inc.
General Hospital · 15d
Cleared Mar 22, 2005
GLOBAL TREASURES FLUID FILLED TEETHER
K043033 · KKO
Global Treasure Industries , Ltd.
Dental · 139d
Cleared Mar 22, 2005
VANGUARD REPROCESSED ULTRASONIC SCALPEL
K043225 · NLQ
Vanguard Medical Concepts, Inc.
General & Plastic Surgery · 120d
Cleared Mar 22, 2005
VANGUARD REPROCESSED HAND-ACTIVATED ULTRASONIC SCALPEL
K043315 · NLQ
Vanguard Medical Concepts, Inc.
General & Plastic Surgery · 111d