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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
44977–45000 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 07, 2012
PUREGRAFT 850/PURE SYSTEM
K113255 · MUU
Cytori Therapeutics, Inc.
General & Plastic Surgery · 125d
Cleared Mar 07, 2012
BIOPSY POSITIONER
K113284 · IZH
Fuji Film Medical Systems
Radiology · 121d
Cleared Mar 07, 2012
NUVANT, MOBILC CARDIAC TELEMETRY
K113372 · QYX
Corventis, Inc.
Cardiovascular · 112d
Cleared Mar 07, 2012
HILLA DIGITAL TRANSFERS
K113575 · EIH
Hilla Technologies, Inc.
Dental · 96d
Cleared Mar 07, 2012
DEXERYL CREAM
K113807 · FRO
Pierre Fabre Medical Devices
General & Plastic Surgery · 75d
Cleared Mar 07, 2012
SUPER SEAL TOOTH DESENSITIZER
K120109 · LBH
Phoenix Dental, Inc.
Dental · 54d
Cleared Mar 07, 2012
LEUCADIA 4.5 MM PEDICLE SCREW SYSTEM
K120355 · NKB
Phygen, LLC
Orthopedic · 30d
Cleared CT Mar 06, 2012
CONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEM
K111268 · LFR
Bayer Healthcare
Chemistry · 307d
Cleared Mar 06, 2012
NEO NEST
K112547 · IMD
Denovo Proucts, LLC
Physical Medicine · 187d
Cleared Mar 06, 2012
ACTIVATOR V-E
K112606 · LXM
Activator Methods International, Ltd.
Physical Medicine · 180d
Cleared Mar 06, 2012
FOOTPRINT ULTRA PK SUTURE ANCHOR
K113274 · MBI
Smith & Nephew, Inc.
Orthopedic · 120d
Cleared Mar 06, 2012
HOLOGIC VISCERAL FAT SOFTWARE
K113356 · KGI
Hologic, Inc.
Radiology · 113d
Cleared Mar 06, 2012
NC TREK OTW CORONARY DILATATION CATHETER
K113464 · LOX
Abbott Vascular
Cardiovascular · 105d
Cleared Mar 06, 2012
KIMONO MICROTHIN WITH AQUA LUBE, REALITY ULTRA LUBRICATED
K113686 · HIS
Mayer Laboratories, Inc.
Obstetrics & Gynecology · 82d
Cleared Mar 06, 2012
DISPOSABLE VINYL EXAM GLOVE, POWDERED
K113790 · LYZ
Full Synergy Medical Products, Inc.
General Hospital · 74d
Cleared Mar 06, 2012
SONICEYE ULTRASOUND TRANSDUCER
K113832 · ITX
Blacktoe Medical Iii, Inc.
Radiology · 70d
Cleared Mar 06, 2012
FORESIGHT U120 URINE ANALYZER
K120124 · JIL
ACON Laboratories, Inc.
Chemistry · 49d
Cleared Mar 06, 2012
THERASAGE HEATING PAD
K120254 · ILY
Therasage Corporation
Physical Medicine · 39d
Cleared Mar 06, 2012
VIVI ERGON-X HF
K120318 · MUH
Vivi S.R.L.
Radiology · 33d
Cleared Mar 06, 2012
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K120358 · LYZ
Hongxin Plastic Products Co., Ltd.
General Hospital · 29d
Cleared Mar 06, 2012
FRESENIUS 2008T HEMODIALYSIS MACHINE
K120505 · KDI
Fresenius Medical Care North America,...
Gastroenterology & Urology · 14d
Cleared Mar 05, 2012
SYMBIQ INFUSION AND ADMINSTRATION SET
K110901 · FRN
Hospira, Inc.
General Hospital · 340d
Cleared Mar 05, 2012
MOBIS, MOVAL, SEMIAL, TETRISMODEL PEEK AND TITANIUM, KIMBA MODEL STANDARD AND...
K111792 · MAX
Signus Medizintechnik GmbH
Orthopedic · 252d
Cleared Mar 05, 2012
VIRTUOSO SYSTEM FOR IHC PR (IE2)
K111869 · NQN
Ventana Medical Systems, Inc.
Pathology · 248d