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
2329–2352 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Dec 02, 2019
Decanting Device
K182819 · LHI
Gcmedica Enterprise Ltd.(Wuxi)
General Hospital · 424d
Cleared Nov 29, 2019
Innonix Antiviral Child's Face Mask
K192105 · OUK
Innonix Technologies Limited
General Hospital · 116d
Cleared Nov 25, 2019
Blue Latex Examination Powder Free Gloves
K192329 · LYY
Jr Engineering & Medical Technologies...
General Hospital · 90d
Cleared Nov 25, 2019
Infant Incubator
K190494 · FMZ
Ningbo David Medical Device Co., Ltd.
General Hospital · 270d
Cleared Nov 25, 2019
Pivot System Sterilization case
K181845 · KCT
Rp Medical, Inc.
General Hospital · 502d
Cleared Nov 22, 2019
3M™ Attest™ Steam Chemical Integrators
K191236 · JOJ
3M Company
General Hospital · 198d
Cleared Nov 21, 2019
SAM IO Intraosseous Access System
K191488 · FMI
Sam? Medical Products, Inc.
General Hospital · 170d
Cleared Nov 19, 2019
Vial Adapter Ø20 mm , Vial Adapter Ø13 mm
K190816 · LHI
Avenir Performance Europeenne Medical...
General Hospital · 235d
Cleared Nov 18, 2019
Digital Thermometer
K183393 · FLL
Joytech Healthcare Co. , Ltd.
General Hospital · 346d
Cleared Nov 16, 2019
3M Comply Hydrogen Peroxide Chemical Indicator
K192937 · JOJ
3M Company
General Hospital · 29d
Cleared Nov 13, 2019
Piper GO-IO Intraosseous Infusion System
K191976 · FMI
Piper Access, LLC
General Hospital · 112d
Cleared Nov 13, 2019
Infrared Thermometer Model MD-H30
K191570 · FLL
Guangzhou Berrcom Medical Device Co.,...
General Hospital · 153d
Cleared Nov 08, 2019
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim...
K192232 · LZA
Hartalega NGC Sdn. Bhd.
General Hospital · 84d
Cleared Nov 08, 2019
Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG*...
K191230 · LZC
O&M Halyard, Inc.
General Hospital · 184d
Cleared Nov 05, 2019
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
K191292 · LYZ
Anhui Powerguard Technology Co., Ltd.
General Hospital · 175d
Cleared Nov 05, 2019
MTS225 and MTS300 Multiple Tray Sterilization Systems
K190541 · KCT
Pmbs, LLC
General Hospital · 246d
Cleared Nov 04, 2019
WellDoc BlueStar
K190013 · MRZ
Welldoc, Inc.
General Hospital · 305d
Cleared Nov 01, 2019
BD Acute Central Line
K190855 · FOZ
Bard Access Systems, Inc. (Bard Has...
General Hospital · 213d
Cleared Nov 01, 2019
STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R)
K181993 · FLE
Sturdy Industrial Co., Ltd.
General Hospital · 463d
Cleared Oct 31, 2019
Belimed Steam Sterilizer MST-H TOP 5000
K191896 · FLE
Belimed AG
General Hospital · 108d
Cleared Oct 28, 2019
primeMidline Catheters
K192802 · PND
Pfm Medical, Inc.
General Hospital · 28d
Cleared Oct 28, 2019
3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228
K192673 · JOJ
3M Company
General Hospital · 32d
Cleared Oct 24, 2019
Latex Surgeon’s Gloves Powder Free with protein content labeling claim of...
K190632 · KGO
Lenora Glove Pvt , Ltd.
General Hospital · 226d
Cleared Oct 23, 2019
Intraosseous infusion device
K191258 · FMI
Einstein Works, LLC
General Hospital · 166d