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
2977–3000 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Mar 31, 2017
THERMOPLASTIC POLYETHYLENE EXAMINATION (TPE) GLOVE
K162626 · LZA
Top Quality Glove Sdn. Bhd
General Hospital · 192d
Cleared Mar 31, 2017
AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low...
K162413 · MLR
STERIS Corporation
General Hospital · 214d
Cleared Mar 31, 2017
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [STERLING/GREY]...
K162186 · LZC
Brightway Holdings Sdn. Bhd.
General Hospital · 239d
Cleared Mar 29, 2017
Palm-Pro Chemo-Guard Nitrile Powder Free Examination Glove
K161929 · LZA
Dipped Products (Thailand) Limited
General Hospital · 258d
Cleared Mar 28, 2017
Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs...
K162405 · LZA
Comfort Rubber Gloves Industries Sdn....
General Hospital · 211d
Cleared Mar 28, 2017
Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module
K161469 · FRN
Hospira, Inc.
General Hospital · 305d
Cleared Mar 27, 2017
Freedom Syringe
K161812 · FMF
Procedure Products, Inc.
General Hospital · 269d
Cleared Mar 27, 2017
Sapphire Infusion Pump
K161667 · FRN
Q Core Medical , Ltd.
General Hospital · 284d
Cleared Mar 24, 2017
VERIFY Incubator for Assert Self Contained Biological Indicators
K163587 · OWP
STERIS Corporation
General Hospital · 94d
Cleared Mar 24, 2017
NITRILE EXAMINATION GLOVE
K163267 · LZA
Brightway Holdings Sdn. Bhd.
General Hospital · 123d
Cleared Mar 24, 2017
VERIFY Assert Self-Contained Biological Indicator
K162701 · OWP
STERIS Corporation
General Hospital · 177d
Cleared Mar 22, 2017
ThermoShield HME Filter
K163300 · CAH
Flexicare Medical Limited.
General Hospital · 120d
Cleared Mar 22, 2017
My Dose Coach
K163099 · NDC
Sanofi, Inc.
General Hospital · 135d
Cleared Mar 22, 2017
Nitrile Blue Powder Free Examination Gloves with Low Dermatitis Potential...
K163017 · LZC
Gmp Medicare Sdn. Bhd.
General Hospital · 145d
Cleared Mar 21, 2017
Nix Ultra Lice Treatment Kit
K163401 · LJL
Medtech Products, Inc.
General Hospital · 106d
Cleared Mar 21, 2017
VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators, VERIFY...
K162758 · JOJ
STERIS Corporation
General Hospital · 172d
Cleared Mar 20, 2017
Sterile Hypodermic Safety Syringes for Single Use
K163162 · MEG
Jiangxi Hongda Medical Equipment...
General Hospital · 130d
Cleared Mar 20, 2017
Sterile Single-use Syringe with Needle
K163161 · FMF
Jiangxi Hongda Medical Equipment...
General Hospital · 130d
Cleared Mar 14, 2017
Safety Blood Collection Set
K163093 · FMI
Jiangsu Shenli Medical Production...
General Hospital · 130d
Cleared Mar 10, 2017
BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless...
K170336 · FOZ
Becton, Dickinson and Company
General Hospital · 36d
Cleared Mar 10, 2017
Infrared Non-contact Thermometer, Model ACT8100
K162509 · FLL
Easywell Biomedicals, Inc.
General Hospital · 183d
Cleared Mar 08, 2017
Vial2Bag Direct Connect
K170095 · LHI
Medimop Medical Project , Ltd.
General Hospital · 56d
Cleared Mar 08, 2017
Q2 Low Pressure Power Injection Extension Set
K162804 · FPA
Quest Medical, Inc.
General Hospital · 154d
Cleared Mar 08, 2017
Burette-type Infusion Sets for Single Use, Disposable Infusion Sets with...
K161898 · FPA
Beijing Fert Technology Co., Ltd.
General Hospital · 240d