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
3097–3120 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Oct 13, 2016
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for...
K160562 · LZA
Hartalega Snd. Bhd.
General Hospital · 227d
Cleared Oct 07, 2016
Turbo-Flo PICC Sets
K161496 · LJS
Cook Incorporated
General Hospital · 128d
Cleared Oct 07, 2016
Sterilization Tray
K160912 · KCT
STERIS Corporation
General Hospital · 189d
Cleared Oct 07, 2016
Prestige Ameritech Pediatric/Child’s Face mask
K160100 · OXZ
Prestige Ameritech
General Hospital · 262d
Cleared Oct 03, 2016
Volumetric Infusion Controller
K153760 · LDR
DEKA Research & Development
General Hospital · 278d
Cleared Sep 27, 2016
STERRAD® NX Sterilizer with ALLClear™ Technology
K160818 · MLR
Advanced Sterilization Products
General Hospital · 187d
Cleared Sep 26, 2016
STERRAD 100NX Sterilizer with ALLClearTM Technology
K160903 · MLR
Advanced Sterilization Products
General Hospital · 178d
Cleared Sep 22, 2016
PowerGlide Pro Midline Catheter
K162377 · FOZ
C.R. Bard, Inc.
General Hospital · 29d
Cleared Sep 22, 2016
MiniMed Quick-serter
K160860 · KZH
Medtronic Minimed
General Hospital · 177d
Cleared Sep 21, 2016
Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T,...
K160816 · FLL
Nexmed Technology Co., Ltd.
General Hospital · 181d
Cleared Sep 21, 2016
CPL Insulin Pen Needle
K151090 · FMI
Cpl Co., Ltd.
General Hospital · 517d
Cleared Sep 16, 2016
Bone Solutions Mixing and Delivery System
K161568 · FMF
Bone Solutions, Inc.
General Hospital · 101d
Cleared Sep 09, 2016
EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with...
K161187 · LZA
Eco Medi Glove Sdn. Bhd.
General Hospital · 135d
Cleared Sep 09, 2016
Sure-Fine Insulin Syringes
K152879 · FMF
Shina Med Corporation
General Hospital · 345d
Cleared Sep 08, 2016
BioFlo Midline Catheter
K161866 · FOZ
Navilyst Medical, Inc.
General Hospital · 63d
Cleared Sep 07, 2016
Signia sterilization tray
K161347 · KCT
Covidien
General Hospital · 114d
Cleared Sep 07, 2016
CareSens Pen Needle, Softip Pen Needle
K160575 · FMI
Yidobio, Inc.
General Hospital · 190d
Cleared Sep 06, 2016
CG+ Arrow JACC
K161765 · LJS
Arrow International, Inc. (Subsidiary...
General Hospital · 71d
Cleared Sep 06, 2016
HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves
K160709 · LZC
Halyard Health
General Hospital · 176d
Cleared Sep 06, 2016
Surgical Face Masks (Ear loops and Tie-on)
K160269 · FXX
San-M Package Co., Ltd.
General Hospital · 217d
Cleared Sep 01, 2016
EMG Pink Nitrile Examination Glove Powder Free
K161320 · LZA
Eco Medi Glove Sdn. Bhd.
General Hospital · 113d
Cleared Sep 01, 2016
Concert Medical Hands-Free Syringe (HFS)
K153599 · FRN
Concert Medical, LLC
General Hospital · 260d
Cleared Sep 01, 2016
Cathtong I PICC Catheter
K153469 · LJS
L&Z Us, Inc.
General Hospital · 275d
Cleared Aug 30, 2016
Halo II Ambulatory Infusion System (also with trade names Nimbus II...
K153193 · FRN
Zyno Medical, LLC
General Hospital · 301d