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

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175,820 results
32473–32496 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 28, 2016
Infrared Thermometer (FT-F11-BT, FT-F21-BT, FT-31-BT, FT-F41-BT)
K152640 · FLL
Fudakang Industries Co., Ltd.
General Hospital · 195d
Cleared Mar 28, 2016
TRYPTIK2C-plate Anterior Cervical Plate System
K153042 · KWQ
Spineart
Orthopedic · 161d
Cleared Mar 28, 2016
Sonicision Cordless Ultrasonic Dissection Device
K153371 · LFL
Covidien, LLC
General & Plastic Surgery · 126d
Cleared CT Mar 28, 2016
ACUVUE (senofilcon C) Soft Contact Lens
K160212 · LPL
Johnson & Johnson Vision Care, Inc.
Ophthalmic · 59d
Cleared Mar 28, 2016
ANATOMIC PEEK PTC Cervical Fusion System
K160528 · ODP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 32d
Cleared Mar 28, 2016
SMV Scientific Schanz Screws
K160603 · HWC
Smv Scientific
Orthopedic · 26d
Cleared Mar 26, 2016
MRII Cranial Drill and Accessories
K160129 · HBG
Mri Interventions, Inc.
Neurology · 66d
Cleared Mar 25, 2016
SOMATOM Perspective
K151765 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 269d
Cleared Mar 25, 2016
EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive...
K151799 · JZO
Phadia AB
Immunology · 267d
Cleared Mar 25, 2016
VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL)
K151923 · NGZ
bioMerieux, Inc.
Microbiology · 256d
Cleared Mar 25, 2016
Vas-Q-Clip
K151943 · FZP
Nanova Biomaterials, Inc.
General & Plastic Surgery · 255d
Cleared Mar 25, 2016
SurgTech Interbody System
K152200 · MAX
Surgtech, Inc.
Orthopedic · 232d
Cleared Mar 25, 2016
MSCB-001
K152274 · EIH
GC America, Inc.
Dental · 226d
Cleared Mar 25, 2016
Great Basin Staph ID/R Blood Culture Panel
K152470 · PAM
Great Basin Scientific, Inc.
Microbiology · 207d
Cleared Mar 25, 2016
U&U Insulin Syringe with/without Safety Retractable Device
K152808 · MEG
U&U Medical Technology Co, Ltd.
General Hospital · 179d
Cleared Mar 25, 2016
DeRoyal Angiography Kits
K152978 · DXT
Deroyal Industries, Inc.
Cardiovascular · 168d
Cleared Mar 25, 2016
Corvocet Biopsy System
K153337 · KNW
Merit Medical Systems, Inc.
Gastroenterology & Urology · 127d
Cleared Mar 25, 2016
VibraPEP
K153441 · BWF
Medica Holdings, LLC
Anesthesiology · 119d
Cleared Mar 25, 2016
Optetrak Logic Metaphyseal Cones
K153595 · JWH
Exactech, Inc.
Orthopedic · 100d
Cleared Mar 25, 2016
iTotal Cruciate Retaining (CR) Knee Replacement System
K153721 · JWH
Conformis, Inc.
Orthopedic · 88d
Cleared Mar 25, 2016
Corin TaperFit Hip Stem
K153725 · JDI
Corin U.S.A. Limited
Orthopedic · 88d
Cleared Mar 25, 2016
Align Anterior Ankle Fusion Plate
K160191 · HRS
Extremity Medical, LLC
Orthopedic · 58d
Cleared Mar 25, 2016
truFreeze System
K160273 · GEH
Csa Medial, Inc.
General & Plastic Surgery · 52d
Cleared Mar 25, 2016
LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6
K160277 · IYN
GE Medical Systems Ultrasound and...
Radiology · 52d