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
31537–31560 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 27, 2016
Precision Screw
K160385 · OLO
Cryptych Pty, Ltd.
Orthopedic · 167d
Cleared Jul 27, 2016
BEAUTIFIL II LS
K160596 · EBF
Shofu Dental Corporation
Dental · 147d
Cleared Jul 27, 2016
Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap
K160755 · FRG
Ahlstrom Nonwovens, LLC
General Hospital · 131d
Cleared Jul 27, 2016
HANAROCare ReJu
K160893 · NUH
M.I. Tech Co., Ltd.
Neurology · 118d
Cleared Jul 27, 2016
Tina-quant Cystatin C Gen.2
K161817 · NDY
Roche Diagnostics Operations (Rdo)
Chemistry · 26d
Cleared Jul 26, 2016
Hudson RCI AquaPak Sterile Prefilled Nebulizers
K153010 · CAF
Teleflexmedical, Inc.
Anesthesiology · 286d
Cleared Jul 26, 2016
Watch-PAT200U
K153070 · MNR
Itamar Medical , Ltd.
Anesthesiology · 278d
Cleared Jul 26, 2016
DuraLazeTM HoLEP Laser Fiber
K153124 · GEX
Medkey, LLC
General & Plastic Surgery · 271d
Cleared Jul 26, 2016
Red2Green Reusable Sharps Container
K153363 · MMK
Triumvirate Environmental, Inc.
General Hospital · 249d
Cleared Jul 26, 2016
InPen
K160629 · FMF
Companion Medical, Inc.
General Hospital · 141d
Cleared Jul 26, 2016
Atteris No-Sting Skin Protectant
K160684 · KMF
Rochal Industries, LLC
General & Plastic Surgery · 137d
Cleared Jul 26, 2016
ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur...
K160757 · CDD
Axis-Shield Diagnostics Limited
Chemistry · 130d
Cleared Jul 26, 2016
EasyStep
K160813 · JDR
Stryker GmbH
Orthopedic · 124d
Cleared Jul 26, 2016
Cook Intraosseous Infusion Needles
K160887 · FMI
Cook Incorporated
General Hospital · 117d
Cleared Jul 26, 2016
Conventus Orthopaedics Ulna Fixation System
K161048 · HRS
Conventus Orthopaedics, Inc.
Orthopedic · 103d
Cleared Jul 26, 2016
Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3
K161198 · ILY
Usa Laser Biotech, Inc.
Physical Medicine · 89d
Cleared Jul 26, 2016
truFreeze System
K161557 · GEH
CSA Medical, Inc.
General & Plastic Surgery · 50d
Cleared Jul 26, 2016
VITRUVIAN ULTIMATE ASPIRATOR
K161722 · QPB
Black & Black Surgical, Inc.
General & Plastic Surgery · 34d
Cleared Jul 25, 2016
cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat System
K153544 · OCC
Iquum, Inc.
Microbiology · 227d
Cleared Jul 25, 2016
t:slim Insulin Delivery System
K160056 · LZG
Tandem Diabetes Care, Inc.
General Hospital · 195d
Cleared Jul 25, 2016
NobelProcera HT ML FCZ Implant Bridge and Framework
K160158 · NHA
Nobel Biocare AB
Dental · 180d
Cleared Jul 25, 2016
Skyn Original Polyisoprene Lubricated Male Condom
K160399 · MOL
Ansell Healthcare Products, LLC
Obstetrics & Gynecology · 164d
Cleared Jul 25, 2016
Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera Coating
K160411 · LYZ
Cardinal Health, Inc.
General Hospital · 160d
Cleared Jul 25, 2016
PacEndo Chlorhexidine
K160577 · KJJ
Pac-Dent International, Inc.
Dental · 146d