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
3793–3816 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Dec 13, 2013
DURABLUE STERILIZATION WRAP
K132060 · FRG
Cardinal Health-Medical Products and...
General Hospital · 163d
Cleared Dec 12, 2013
MEDCOMP GEN III POWER INJECTABLE PORT
K132177 · LJT
Medcomp ( Medical Components)
General Hospital · 150d
Cleared Dec 12, 2013
WTF SECURA SYRINGE AND NEEDLE
K132120 · FMF
Beijing Wantefu Medical Apparatus...
General Hospital · 156d
Cleared Dec 11, 2013
POLYSITE IMPLANTABLE INFUSION PORTS
K122834 · LJT
Perouse Medical
General Hospital · 450d
Cleared Dec 09, 2013
CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0
K130394 · MEA
Smiths Medical Asd, Inc.
General Hospital · 297d
Cleared Dec 06, 2013
DC SERIES FLUID WARMING CABINET, DC SERIES FLUID WARMING CABINET
K132202 · LGZ
Enthermics Medical Systems, Inc.
General Hospital · 143d
Cleared Dec 05, 2013
SAFETOUCH PSV WINGED INFUSION SET WITH/WITHOUT FILTER
K132153 · FOZ
Nipro Medical Corporation
General Hospital · 146d
Cleared Dec 02, 2013
CJ-TYPE: METAL HANDLE WITH GUIDE TUBE, PJ-TYPE: PLASTIC HANDLE WITH GUIDE...
K132896 · MQX
Asia-Med GmbH and CO KG
General Hospital · 77d
Cleared Dec 02, 2013
KINSA SMART THERMOMETER
K132514 · FLL
Kinsa, Inc.
General Hospital · 112d
Cleared Nov 27, 2013
SYNMAX SYNTHETIC EXAMINATION VINYL GLOVES, POWDER FREE, BLUE COLOR
K132201 · LYZ
Zibo Intco Medical Products Co., Ltd.
General Hospital · 134d
Cleared Nov 26, 2013
STERITEC GREEN CARD PACK BOWIE-DICK TEST
K132372 · JOJ
Steritec Products Mfg Co, Inc.
General Hospital · 119d
Cleared Nov 26, 2013
POWDER FREE VINYL PATIENT EXAMINATION GLVOES, LIGHT YELLOW COLOR
K131828 · LYZ
Jiangsu Handsafe Glove Co., Ltd.
General Hospital · 159d
Cleared Nov 26, 2013
DISPOSABLE INFUSION SET
K131646 · LHI
Shanghai Jinta Medical Co., Ltd.
General Hospital · 174d
Cleared Nov 26, 2013
SPSMEDICAL SPORVIEW 10 STEAM SELF CONTAINED BIOLOGICAL INDICATOR
K122024 · FRC
Spsmedical Supply Corp.
General Hospital · 503d
Cleared Nov 25, 2013
DANA REUSABLE BI TEST PACK
K130135 · JOJ
Dana Products, Inc.
General Hospital · 311d
Cleared Nov 22, 2013
TOPTOUCH /OTHER CLIENTS PRIVATE LABELING
K131826 · LYZ
Jiangsu Toptouch Glove Co., Ltd.
General Hospital · 155d
Cleared Nov 20, 2013
NMI PICC III
K133264 · LJS
Navilyst Medical, Inc.
General Hospital · 28d
Cleared Nov 20, 2013
STERILE PISTON HYPODERMIC SYRINGES (WITH/WITHOUT NEEDLE), HYPODERMIC NEEDLES
K130230 · FMF
Wuxi Yushou Medical Applicances Co.,...
General Hospital · 295d
Cleared Nov 20, 2013
SAFETY HYPODERMIC NEEDLES WITH/WITHOUT SYRINGE
K130212 · FMI
Wuxi Yushou Medical Applicances Co.,...
General Hospital · 295d
Cleared Nov 15, 2013
SHARPSOLOGY 2
K133031 · MMK
Industrial Water Solutions, Inc.
General Hospital · 50d
Cleared Nov 13, 2013
U&U STERILE HYPODERMIC NEEDLE
K132552 · FMI
U&U Medical Technology Co, Ltd.
General Hospital · 91d
Cleared Nov 12, 2013
STERILE EMPTY GLASS CONTAINER, 250ML, STERILE EMPTY GLASS CONTAINER, 500 ML,...
K132276 · KPE
Hospira, Inc.
General Hospital · 113d
Cleared Nov 12, 2013
NON-CONTACT INFRARED THERMOMETER
K131243 · FLL
Shenzhen Jumper Medical Equipment...
General Hospital · 195d
Cleared Nov 08, 2013
BYTECH
K130101 · LYZ
Bytech Dongtai Co., Ltd.
General Hospital · 297d