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
3169–3192 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jul 06, 2016
Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets,...
K153074 · LZH
Covidien
General Hospital · 258d
Cleared Jun 30, 2016
ViaValve Safety I.V. Catheter
K160235 · FOZ
Smiths Medical Asd, Inc.
General Hospital · 150d
Cleared Jun 30, 2016
STERIZONE Sterilizer
K153689 · PJJ
Tso3, Inc.
General Hospital · 190d
Cleared Jun 28, 2016
Canadian Technical Tape, LTd. LF Process Indicator Steam Sterilization Tape
K161024 · JOJ
Canadian Technical Tape, Ltd.
General Hospital · 77d
Cleared Jun 28, 2016
PowerMidline Catheter
K153393 · PND
C.R. Bard, Inc.
General Hospital · 217d
Cleared Jun 28, 2016
Jeesung Safety Syringe and Single Use Needles
K152606 · MEG
Jeesung Medical Co., Ltd.
General Hospital · 291d
Cleared Jun 24, 2016
Unifine Pentips/ Unifine Pentips Plus
K152339 · FMI
Owen Mumford, Ltd.
General Hospital · 310d
Cleared Jun 23, 2016
NIO-P
K160805 · FMI
Waismed, Ltd.
General Hospital · 92d
Cleared Jun 23, 2016
Synthetic Vinyl Examination Gloves, Powder-Free, Yellow
K160468 · LYZ
Inpro Technology Device Factory
General Hospital · 125d
Cleared Jun 23, 2016
EMG Powder Free Nitrile Examination Glove (Blue) with Peppermint Scented
K152937 · LZA
Eco Medi Glove Sdn. Bhd.
General Hospital · 262d
Cleared Jun 23, 2016
QiF Blood and Fluid Warmer
K150404 · LGZ
Quality IN Flow , Ltd.
General Hospital · 491d
Cleared Jun 22, 2016
CliniCloud Non-contact Thermometer, Model SPL1024
K161325 · FLL
Stethocloud Pty.Ltd (Clinicloud)
General Hospital · 41d
Cleared Jun 20, 2016
DermaTherapy Bed Linens
K152884 · FMW
Precision Fabrics Group, Inc.
General Hospital · 264d
Cleared Jun 17, 2016
Withings Thermo (Model SCT01)
K160544 · FLL
Withings
General Hospital · 112d
Cleared Jun 17, 2016
Sol-M Insulin Syringe, Sol-M TB Syringe
K153537 · FMF
Sol-Millennium Medical, Inc.
General Hospital · 190d
Cleared Jun 15, 2016
Disposable Surgical Face Mask
K153496 · FXX
Xiantao Rayxin Medical Products Co.,...
General Hospital · 191d
Cleared Jun 14, 2016
Airborne Phototherapy Light
K160238 · LBI
International Biomedical
General Hospital · 134d
Cleared Jun 14, 2016
PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH Catheter
K151985 · LJS
C.R. Bard, Inc.
General Hospital · 333d
Cleared Jun 09, 2016
Oak Ridge Products Sharps Containers
K161180 · MMK
Oak Ridge Products, LLC
General Hospital · 43d
Cleared Jun 09, 2016
3M Attest Rapid Readout Biological Indicator
K160546 · FRC
3M Company
General Hospital · 104d
Cleared Jun 08, 2016
ProteXsure Safety Capsule System
K152597 · FMI
Starcap Medical, LLC ( Dba Prism...
General Hospital · 271d
Cleared Jun 07, 2016
Getinge Series Warming Cabinet
K153713 · LHC
Getinge Sourcing, LLC
General Hospital · 166d
Cleared Jun 07, 2016
IMPROSAFE Blood Collection Set with Pre-attached Holder, IMPROVACUTER Blood...
K153388 · FMI
Guangzhou Improve Medical Instruments...
General Hospital · 197d
Cleared Jun 07, 2016
SureFine Pen Needle
K152877 · FMI
Shina Med Corporation
General Hospital · 251d