FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

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

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175,820 results
25537–25560 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 29, 2018
Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan...
K181232 · LPL
Largan Medical Co., Ltd.
Ophthalmic · 51d
Cleared Jun 29, 2018
MotoCLIP/HiMAX Implant System
K181410 · JDR
Crossroads Extremity Systems, LLC
Orthopedic · 30d
Cleared Jun 28, 2018
Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM
K172457 · DPW
Deltex Medical Limited
Cardiovascular · 318d
Cleared Jun 28, 2018
KJ ZIRCONIA Implant System
K173116 · DZE
Kj Meditech Co., Ltd.
Dental · 272d
Cleared Jun 28, 2018
GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable...
K173162 · PWJ
Ethicon, Inc.
Gastroenterology & Urology · 272d
Cleared Jun 28, 2018
TEMP BASIC, TEMP PREMIUM, TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE,...
K180562 · EBG
Zirkonzahn GmbH
Dental · 115d
Cleared Jun 28, 2018
LOGIC 4K CAMERA CONTROLLER, LOGIC 4K CAMERA HEAD
K180583 · FET
Richard Wolf Medical Instruments...
Gastroenterology & Urology · 115d
Cleared Jun 28, 2018
FaSet Fixation System
K180729 · MRW
Huvexel Co. , Ltd.
Orthopedic · 100d
Cleared Jun 28, 2018
PROLENE Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh, PROLENE...
K180829 · FTL
Ethicon, Inc.
General & Plastic Surgery · 90d
Cleared Jun 28, 2018
ZMI Self-Adhesive Electrodes
K180865 · GXY
Zmi Electronics , Ltd.
Neurology · 87d
Cleared Jun 28, 2018
Sapphire II PRO Balloon Dilatation Catheter
K180921 · LOX
Orbusneich Medical Trading, Inc.
Cardiovascular · 80d
Cleared Jun 28, 2018
Beacon Advanced CO2 Laser System
K180993 · GEX
Omniguide, Inc.
General & Plastic Surgery · 73d
Cleared Jun 28, 2018
Beurer IPL 5500 device/ IPL 5000/ IPL PureSkin Pro
K181121 · OHT
Home Well Trading, Ltd.
General & Plastic Surgery · 59d
Cleared Jun 28, 2018
Angled Tip Ureteral Catheter
K181144 · KOD
Cook Incorporated
Gastroenterology & Urology · 58d
Cleared Jun 28, 2018
Juliet Ti
K181203 · MAX
Spineart
Orthopedic · 52d
Cleared Jun 28, 2018
Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf Collimator
K181404 · IYE
Varian Medical Systems, Inc.
Radiology · 30d
Cleared Jun 28, 2018
ArtiClip LAA Exclusion System
K181474 · PZX
AtriCure, Inc.
Cardiovascular · 24d
Cleared Jun 27, 2018
HD LifeSciences Cervical IBFD System
K180364 · ODP
Hd Lifesciences, LLC
Orthopedic · 135d
Cleared Jun 27, 2018
Shockwave Medical Intravascular Lithotripsy (IVL) System
K180454 · PPN
Shockwave Medical, Inc.
Cardiovascular · 127d
Cleared Jun 27, 2018
Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with...
K180646 · LZC
Halyard Health
General Hospital · 107d
Cleared Jun 27, 2018
Medifine Pen Needle 3 Bevel
K180720 · FMI
Medibio USA, LLC
General Hospital · 100d
Cleared Jun 27, 2018
CALLISTO eye
K180858 · NFJ
Carl Zeiss Meditec, AG
Ophthalmic · 86d
Cleared Jun 27, 2018
Alleye
K180895 · HOQ
Oculocare Medical AG
Ophthalmic · 83d
Cleared Jun 27, 2018
OverStitch Endoscopic Suturing System and Accessories
K181141 · OCW
Apollo Endosurgery
Gastroenterology & Urology · 57d