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
27193–27216 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 15, 2017
EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT...
K172888 · MAX
Eit Emerging Implant Technologies GmbH
Orthopedic · 85d
Cleared Dec 15, 2017
Kindguard Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
K173017 · LYZ
Anhui Kindguard Medical Supplies...
General Hospital · 79d
Cleared Dec 15, 2017
BD Nexiva Diffusics Closed IV Catheter Systems
K173354 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 51d
Cleared Dec 15, 2017
Raider Guidewire
K173532 · DQX
Vascular Solutions, Inc.
Cardiovascular · 30d
Cleared Dec 15, 2017
Strange Bile Duct Stone Exploration Set
K173687 · LQR
Cook Incorporated
Gastroenterology & Urology · 14d
Cleared Dec 14, 2017
TAURUS PEEK Cage System
K170389 · MAX
Medyssey USA, Inc.
Orthopedic · 309d
Cleared Dec 14, 2017
Arthrex Univers Revers Apex Humeral Stems
K170414 · PHX
Arthrex, Inc.
Orthopedic · 307d
Cleared Dec 14, 2017
ISP Safety Huber Needle Infusion Set
K170881 · PTI
Infusion Safety Products, Inc.
General Hospital · 265d
Cleared Dec 14, 2017
Vitrification Kit and Thawing Kit
K171748 · MQL
Kitazato Corporation
Obstetrics & Gynecology · 184d
Cleared Dec 14, 2017
Cascadia Interbody System
K172009 · MAX
K2m, Inc.
Orthopedic · 164d
Cleared Dec 14, 2017
CAREline Airless Hemodialysis Blood Tubing Sets
K172238 · KOC
Fresenius Medical Care Renal...
Gastroenterology & Urology · 141d
Cleared Dec 14, 2017
InFill® Interbody Fusion Device
K172349 · MAX
Pinnacle Spine Group, LLC
Orthopedic · 133d
Cleared Dec 14, 2017
NuVasive® Modulus-C Interbody System
K172676 · ODP
Nu Vasive, Incorporated
Orthopedic · 100d
Cleared Dec 14, 2017
E-CUBE 8
K172732 · IYN
Alpinion Medical Systems Co., Ltd.
Radiology · 94d
Cleared Dec 14, 2017
NobelPerfect Abutments
K172854 · NHA
Nobel Biocare AB
Dental · 85d
Cleared Dec 14, 2017
Infinix-i, INFX-8000V, V7.0
K172863 · OWB
Toshibamedical Systems Corporation
Radiology · 85d
Cleared Dec 14, 2017
WishBone K-Wire System
K173013 · HTY
Wishbone Medical, Inc.
Orthopedic · 78d
Cleared Dec 14, 2017
Holycon Synthetic Absorbable Sutures
K173043 · GAM
Nantong Holycon Medical Devices Co.,...
General & Plastic Surgery · 77d
Cleared Dec 14, 2017
Cannulated Screw Internal Fixation System
K173286 · HWC
Life Spine, Inc.
Orthopedic · 59d
Cleared Dec 14, 2017
2MP Color LCD Monitor CL-S200, 3MP Color LCD Monitor CL-S300
K173434 · PGY
Jvckenwood Corporation
Radiology · 42d
Cleared Dec 14, 2017
Akros FibuLink™ Syndesmosis Repair Kit
K173550 · HTN
Akros Medical
Orthopedic · 28d
Cleared Dec 13, 2017
SAM CRRT Unit, SAM Cassette CRRT
K170790 · KDI
Spectral Medical, Inc.
Gastroenterology & Urology · 272d
Cleared Dec 13, 2017
Disposable Insulin Pen Needle
K170846 · FMI
Jiangsu Caina Technology Co., Ltd.
General Hospital · 267d
Cleared Dec 13, 2017
Medacta Shoulder System: Threaded Glenoid Baseplate
K171058 · PHX
Medacta International S.A.
Orthopedic · 247d