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
66745–66768 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 11, 2005
ACUPUNCTURE NEEDLES
K043506 · MQX
Marknew Products
General Hospital · 53d
Cleared Feb 11, 2005
INTERV BRAND SNARELOK BONE MARROW BIOPSY NEEDLE
K043523 · KNW
Medical Device Technologies, Inc.
Gastroenterology & Urology · 53d
Cleared Feb 11, 2005
WU'S POWERED WHEELCHAIR, MAMBO 36X
K050010 · ITI
Wu'S Tech Co., Ltd.
Physical Medicine · 39d
Cleared Feb 11, 2005
WU'S POWERED WHEELCHAIR, MAMBO F 120
K050011 · ITI
Wu'S Tech Co., Ltd.
Physical Medicine · 39d
Cleared Feb 11, 2005
LUCION
K050033 · LLZ
Mevisys Co., Ltd.
Radiology · 35d
Cleared Feb 11, 2005
MODIFICATION TO AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER
K050073 · DQY
Invatec Innovative Technologies, S.R.L.
Cardiovascular · 30d
Cleared Feb 11, 2005
HARVARD 2 SYRINGE PUMP, MODEL 2001-001
K050107 · FRN
Harvard Clinical Technology
General Hospital · 24d
Cleared Feb 11, 2005
TRILLIUM BIOPUMP PLUS, MODEL BPX80T
K050109 · KFM
Medtronic Perfusion Systems
Cardiovascular · 24d
Cleared Feb 11, 2005
THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70 AND MP90 INTELLIVUE PATIENT...
K050141 · MHX
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 17d
Cleared Feb 11, 2005
EXPA-SYL
K050180 · MVL
Produits Dentaires Pierre Rolland
Dental · 16d
Cleared Feb 11, 2005
ASIAN INTRAMEDULLARY HIP SCREW NAILS
K050226 · HWC
Smith & Nephew, Inc.
Orthopedic · 10d
Cleared Feb 11, 2005
STEALTH PRODUCTS SEATING SYSTEM
K050264 · ITI
Stealth Products
Physical Medicine · 7d
Cleared Feb 10, 2005
TRIDENT ACETABULAR SYSTEM
K033716 · LPH
Howmedica Osteonics Corp.
Orthopedic · 442d
Cleared Feb 10, 2005
ELECTROSURGICAL PENCILS
K040780 · GEI
Hangzhou Shuyou Medical Instrument...
General & Plastic Surgery · 321d
Cleared Feb 10, 2005
VECTORVISION OSTEOTOMY
K042513 · HAW
Brainlab AG
Neurology · 148d
Cleared Feb 10, 2005
MONOCHROME LCD MONITOR, RADIFORCE G51
K042755 · LLZ
Eizo Nanao Corporation
Radiology · 129d
Cleared Feb 10, 2005
APEX MODULAR HA HIP STEM
K043123 · LPH
Apex Surgical, LLC
Orthopedic · 90d
Cleared Feb 10, 2005
PATHWAY URETERAL ACCESS SHEATH, PATHWAY EXPANDABLE URETERAL ACCESS SHEATH
K043254 · EZN
Onset Medical Corporation
Gastroenterology & Urology · 78d
Cleared Feb 10, 2005
POTASSIUM TEST KIT AND ELECTROLYTE CAL 1 AND 2
K043267 · CEJ
Randox Laboratories, Ltd.
Chemistry · 76d
Cleared Feb 10, 2005
OSTEOFIL, OPTEFIL, REGENAFIL, RTI ALLOGRAFT PASTE
K043420 · MQV
Regeneration Technologies, Inc.
Orthopedic · 59d
Cleared Feb 10, 2005
OSTEOMED PEDIATRIC INTRAORAL MANDIBULAR DISTRACTION SYSTEM
K043434 · MQN
Osteomed LP
Dental · 59d
Cleared Feb 10, 2005
HEMOCHRON SIGNATURE ELITE
K050016 · JPA
International Technidyne Corp.
Hematology · 37d
Cleared Feb 10, 2005
COULTER LH 750 HEMATOLOGY ANALYZER
K050057 · GKZ
Beckman Coulter, Inc.
Hematology · 30d
Cleared Feb 10, 2005
GEMIFLOXACIN, 5UG BBL SENSI-DISC
K050062 · JTN
Becton, Dickinson & CO
Microbiology · 30d