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
18913–18936 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 14, 2020
Spirotrac
K201562 · BZG
Vitalograph (Ireland) , Ltd.
Anesthesiology · 126d
Cleared Oct 14, 2020
Merit Hydrophilic Guide Wire
K201595 · DQX
Merit Medical Systems, Inc.
Cardiovascular · 124d
Cleared Oct 14, 2020
CONSTRUX Mini PTC Spacer System
K202666 · ODP
Orthofix, Inc.
Orthopedic · 30d
Cleared Oct 13, 2020
Astroglide Organix Liquid
K200114 · NUC
Biofilm, Inc.
Obstetrics & Gynecology · 266d
Cleared CT Oct 13, 2020
G21 Cement, VADER® Pedicle System
K200596 · PML
Icotec AG
Orthopedic · 221d
Cleared Oct 13, 2020
Skeletal Dynamics Ulnar Shortening Plating System
K201962 · HRS
Skeletal Dynamics, Inc.
Orthopedic · 90d
Cleared Oct 13, 2020
Zavation IBF System
K202305 · MAX
Zavation Medical Products, LLC
Orthopedic · 60d
Cleared Oct 11, 2020
Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free...
K200633 · LZC
0 & M Halyard, Inc.
General Hospital · 215d
Cleared Oct 11, 2020
Yushan X-Ray Flat Panel Detector with DROC
K201528 · MQB
Innocare Optoelectronics Corp.
Radiology · 125d
Cleared Oct 11, 2020
Voluson SWIFT, Voluson SWIFT+
K201828 · IYN
GE Medical Systems Ultrasound and...
Radiology · 101d
Cleared Oct 11, 2020
syngo.CT Neuro Perfusion
K202213 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 66d
Cleared Oct 11, 2020
Quantib Prostate
K202501 · LLZ
Quantib B.V.
Radiology · 41d
Cleared Oct 09, 2020
Zeos Aqua Vision Pump and tube
K192921 · HRX
Hemodia Sas
Orthopedic · 359d
Cleared Oct 09, 2020
Stethee Pro 1, Stethee Pro Software System
K193631 · DQD
M3Dicine Pty , Ltd.
Cardiovascular · 287d
Cleared Oct 09, 2020
BIOTEQ Drainage Catheter Set (One Step Type)
K200103 · FGE
Bioteque Corporation
Gastroenterology & Urology · 266d
Cleared Oct 09, 2020
V20, V20a, AVSM3 SNF
K200434 · DXN
Mediana Co., Ltd.
Cardiovascular · 228d
Cleared Oct 09, 2020
Multi-LinkTM X2 ECG Adapter and Leadwires
K200510 · DSA
Vyaire Medical, Inc.
Cardiovascular · 221d
Cleared Oct 09, 2020
Luce Ceramic Bracket
K201038 · NJM
Luce Castle Co., Ltd.
Dental · 172d
Cleared Oct 09, 2020
SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation Catheter
K201377 · LIT
Cordis Corporation
Cardiovascular · 136d
Cleared Oct 09, 2020
AEON Endoscopic Stapler
K201882 · GDW
Lexington Medical, Inc.
General & Plastic Surgery · 93d
Cleared Oct 09, 2020
BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4...
K201983 · PFO
Med-El Elektromedizinische Geraete GmbH
Ear, Nose, Throat · 84d
Cleared Oct 09, 2020
Medline ENfit OTC Feeding Syringe
K202285 · PNR
Medline Industries, Inc.
Gastroenterology & Urology · 58d
Cleared Oct 09, 2020
Instrument Clamps Electromagnetic
K202609 · PGW
Stryker Corporation
Ear, Nose, Throat · 30d
Cleared Oct 09, 2020
Klassic Knee System Tibial Inserts, PS-Max
K202740 · JWH
Total Joint Orthopedics, Inc.
Orthopedic · 21d