FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: General Hospital ×
17,791 results
3145–3168 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jul 28, 2016
POLYISOPRENE POWDER FREE SURGICAL UNDERGLOVE, POLYISOPRENE POWDER FREE...
K161008 · KGO
Hartalega Sdn Bhd
General Hospital · 108d
Cleared Jul 28, 2016
Cardinal Health Isolation Gown
K160339 · FYC
Cardinal Health200, LLC
General Hospital · 171d
Cleared Jul 27, 2016
Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap
K160755 · FRG
Ahlstrom Nonwovens, LLC
General Hospital · 131d
Cleared Jul 26, 2016
Cook Intraosseous Infusion Needles
K160887 · FMI
Cook Incorporated
General Hospital · 117d
Cleared Jul 26, 2016
InPen
K160629 · FMF
Companion Medical, Inc.
General Hospital · 141d
Cleared Jul 26, 2016
Red2Green Reusable Sharps Container
K153363 · MMK
Triumvirate Environmental, Inc.
General Hospital · 249d
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
t:slim Insulin Delivery System
K160056 · LZG
Tandem Diabetes Care, Inc.
General Hospital · 195d
Cleared Jul 22, 2016
Vis-U-All Low Temperature Sterilization Pouch/Tubing
K160908 · FRG
STERIS Corporation
General Hospital · 112d
Cleared Jul 20, 2016
Operio
K153498 · ORC
Toul Meditech AB
General Hospital · 226d
Cleared Jul 20, 2016
ARC InstaTemp Non-Touch Thermometer, ARC InstaTemp MD Non-Touch Thermometer
K152905 · FLL
Arc Devices Limited
General Hospital · 293d
Cleared Jul 20, 2016
EVOTECH ECR
K152189 · FEB
Advanced Sterilization Products (Asp)
General Hospital · 350d
Cleared Jul 15, 2016
Fudakang Bluetooth Digital Thermometer (Model: BT-A41CN-BT)
K160308 · FLL
Fudakang Industrial Co., Ltd.
General Hospital · 162d
Cleared Jul 15, 2016
N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12
K160271 · MSH
San-M Package Co., Ltd.
General Hospital · 164d
Cleared Jul 14, 2016
Powder Free Grey Vinyl Examination Gloves
K161072 · LYZ
Zibo Flourish Trading Co., Ltd.
General Hospital · 87d
Cleared Jul 13, 2016
t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device...
K160482 · LZG
Tandem Diabetes Care, Inc.
General Hospital · 142d
Cleared Jul 12, 2016
SUNGSHIM STERILE SINGLE USE INSULIN SYRINGE
K152803 · FMF
Sung Shim Medicare Co., Ltd.
General Hospital · 288d
Cleared Jul 11, 2016
Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves...
K160875 · KGO
Cardinal Health, Inc.
General Hospital · 103d
Cleared Jul 11, 2016
JSM Insulin Pen Needle
K152166 · FMI
Jeesung Medical Co., Ltd.
General Hospital · 342d
Cleared Jul 08, 2016
LITe BIO Delivery System
K160978 · FMF
Stryker Corporation
General Hospital · 92d
Cleared Jul 08, 2016
BD U-500 INSULIN SYRINGE
K151870 · FMF
Becton, Dickinson and Company
General Hospital · 365d
Cleared Jul 07, 2016
Gemini Sterilization Wrap
K152564 · FRG
Medline Industries, Inc.
General Hospital · 302d
Cleared Jul 06, 2016
BD SafeAssist
K161553 · FMI
Becton, Dickinson and Company
General Hospital · 30d
Cleared Jul 06, 2016
V-PRO® 1 Plus and V-PRO® maX Low Temperature
K160433 · MLR
STERIS Corporation
General Hospital · 141d