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
2545–2568 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Dec 17, 2018
NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)
K182387 · FMF
Novo Nordisk, Inc.
General Hospital · 104d
Cleared Dec 14, 2018
Acu-sInQ Complete Endoscope Cleaning Aid System
K181865 · FEB
STERIS Corporation
General Hospital · 155d
Cleared Dec 14, 2018
NRFit Syringe
K181374 · QEH
Jiangsu Caina Medical Co.,Ltd
General Hospital · 204d
Cleared Dec 14, 2018
SCIg60 Infusion System
K173783 · PKP
Emed Technologies Corporation
General Hospital · 366d
Cleared Dec 13, 2018
neoBLUE blanket LED Phototherapy System
K182178 · LBI
Natus Medical Incorporated
General Hospital · 122d
Cleared Dec 11, 2018
Cardinal Health Sterilization Wrap
K181174 · FRG
Cardinal Health200, LLC
General Hospital · 223d
Cleared Dec 10, 2018
CelerityTM 10 STEAM Chemical Indicator
K182724 · JOJ
STERIS Corporation
General Hospital · 73d
Cleared Dec 10, 2018
Disposable Temperature Probe
K181967 · FLL
Shenzhen Launch Electrical Co., Ltd.
General Hospital · 140d
Cleared Dec 06, 2018
No-contact Forehead Thermometer
K173048 · FLL
Dongguan Simzo Electronic Technology...
General Hospital · 434d
Cleared Dec 06, 2018
RII Smart IR Thermometer
K163601 · FLL
Radiant Innovation, Inc.
General Hospital · 715d
Cleared Dec 03, 2018
Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles,...
K182146 · FMI
Sol-Millennium Medical, Inc.
General Hospital · 117d
Cleared Nov 30, 2018
Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs...
K182600 · LZA
Better Care Plastic Technology Co., Ltd.
General Hospital · 70d
Cleared Nov 30, 2018
BD PhaSeal Optima Closed System Transfer Device
K181221 · ONB
Becton, Dickinson and Company
General Hospital · 207d
Cleared Nov 30, 2018
welloStationX
K180298 · FLL
Wello, Inc.
General Hospital · 301d
Cleared Nov 28, 2018
Non-contact Infrared Thermometer
K180207 · FLL
Alicn Medical (Shenzhen), Inc.
General Hospital · 308d
Cleared Nov 21, 2018
Isolette 8000 Plus
K182977 · FMZ
Draeger Medical Systems, Inc.
General Hospital · 26d
Cleared Nov 21, 2018
Jet Power Injectable PICC
K180546 · LJS
Jet Medical, Inc.
General Hospital · 265d
Cleared Nov 20, 2018
VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable...
K182931 · FRC
Steris Corporations
General Hospital · 29d
Cleared Nov 20, 2018
COCET Digital Thermometer (Models...
K182652 · FLL
Kangfu Medical Equipment Factory
General Hospital · 57d
Cleared Nov 20, 2018
Infrared Thermometer
K182133 · FLL
Shenzhen AOJ Medical Technology Co.,...
General Hospital · 106d
Cleared Nov 20, 2018
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Low...
K181857 · LZA
Kossan International Sdn Bhd
General Hospital · 132d
Cleared Nov 16, 2018
Powder Free Examination Gloves with Colloidal Oatmeal USP and Tested for Use...
K180645 · LZA
Hartalega Sdn Bhd
General Hospital · 249d
Cleared Nov 16, 2018
InstruSafe(R) Sterilization Container
K180528 · KCT
Summit Medical, Inc.
General Hospital · 261d
Cleared Nov 15, 2018
Nitrile Glove Powder Free Black
K182528 · LZA
Haining Medical Products Co., Ltd.
General Hospital · 62d