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
3049–3072 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Dec 21, 2016
DAIYANG Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
K162259 · LYZ
Zibo Daiyang Plastic Company
General Hospital · 132d
Cleared Dec 21, 2016
Scope Buddy Plus Endoscope Flushing Aid
K162128 · FEB
Medivators, Inc.
General Hospital · 142d
Cleared Dec 21, 2016
ulrich Transfer Set
K161723 · PQH
Ulrich GmbH & Co. KG
General Hospital · 182d
Cleared Dec 21, 2016
Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey]...
K161215 · LZA
Brightway Holdings Sdn. Bhd.
General Hospital · 236d
Cleared Dec 20, 2016
Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim...
K160928 · KGO
Hartalega Sdb. Bhd.
General Hospital · 260d
Cleared Dec 20, 2016
K3PRO SURGICAL TRAY
K160574 · KCT
Argon Med. Productions Vertriebs...
General Hospital · 294d
Not Cleared Dec 20, 2016
Ultravision Visual Clearing System
DEN150022 · PQM
Alesi Surgical, Ltd.
General Hospital · 574d
Cleared Dec 19, 2016
BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with...
K162081 · FMF
Becton, Dickinson and Company
General Hospital · 145d
Cleared Dec 19, 2016
Vinyl Exam Gloves, Powder Free, Clear
K161390 · LYZ
Zibo Hongchin Plastic and Rubber Co.,...
General Hospital · 214d
Cleared Dec 19, 2016
Paclitaxel Sets
K160007 · FPA
Baxter Healthcare Corporation
General Hospital · 350d
Cleared Dec 15, 2016
MRidium 3860+ MRI infusion Pump/ Monitoring System
K143369 · FRN
Iradimed Corporation
General Hospital · 751d
Cleared Dec 14, 2016
PowerMidline Catheter
K162900 · PND
C.R. Bard, Inc.
General Hospital · 58d
Cleared Dec 13, 2016
Cloud Smart Thermometer
K160306 · FLL
Guangzhou Bosma Technology Co, Ltd.
General Hospital · 313d
Cleared Dec 12, 2016
ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500
K162442 · FYA
Gri Medical & Electrical Technology...
General Hospital · 103d
Cleared Dec 12, 2016
neoBLUE compact LED Phototherapy System
K160745 · LBI
Natus Medical Incorporated
General Hospital · 269d
Cleared Dec 09, 2016
Jewel Precision Reusable Rigid Sterilization Container System
K162600 · KCT
Jewel Precision Sheet Metal &...
General Hospital · 81d
Cleared Dec 09, 2016
BD Pen Needle
K162516 · FMI
Becton, Dickinson and Company
General Hospital · 91d
Cleared Dec 06, 2016
Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport...
K162304 · FPA
Quest Medical, Inc.
General Hospital · 111d
Cleared Dec 06, 2016
OnSite-IV
K161800 · LHI
Pharmc, LLC
General Hospital · 159d
Cleared Dec 06, 2016
Hospira Sapphire Sets
K160492 · MRZ
Hospira, Inc.
General Hospital · 288d
Cleared Dec 05, 2016
Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1
K161728 · FLL
Microfile Intellectual Property GmbH
General Hospital · 166d
Cleared Dec 01, 2016
SCIg60 Infuser
K161906 · PKP
Emed Technologies Corporation
General Hospital · 142d
Cleared Nov 30, 2016
Solution Set for Epidural Use
K161323 · FPA
Baxter Healthcare Corporation
General Hospital · 203d
Cleared Nov 28, 2016
Powder Free Polychloroprene Examination Glove Blue, Powder Free...
K161932 · LZA
Terang Nusa Sdn Bhd
General Hospital · 137d