Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: General Hospital ×
17,825 results
2353–2376 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Dec 13, 2019
neria guard Infusion Set
K192647 · FPA
Unomedical A/S
General Hospital · 80d
Cleared Dec 13, 2019
MEDRAD Stellant FLEX CT Injection System with Certegra Workstation
K192370 · DXT
Bayer Medical Care, Inc.
General Hospital · 105d
Cleared Dec 13, 2019
Aero Blue Performance Surgical Gowns
K192362 · FYA
O&M Halyard, Inc.
General Hospital · 105d
Cleared Dec 13, 2019
Infrared Thermometer, model: PC808
K190717 · FLL
Shenzhen Pacom Medical Instruments...
General Hospital · 268d
Cleared Dec 10, 2019
SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid...
K192929 · MED
STERIS Corporation
General Hospital · 54d
Cleared Dec 10, 2019
Health Line CT CVC
K192533 · FOZ
Health Line International Corporation
General Hospital · 85d
Cleared Dec 05, 2019
MEDRAD Mark 7 Arterion Injection System
K193028 · DXT
Bayer Medical Care, Inc.
General Hospital · 36d
Cleared Dec 03, 2019
Straumann Modular Cassette
K191522 · KCT
Institut Straumann AG
General Hospital · 176d
Cleared Dec 02, 2019
Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip
K192374 · FXX
Cardinal Health200, LLC
General Hospital · 94d
Cleared Dec 02, 2019
mCare®Powder-free Nitrile Blue Examination Gloves with Chemotherapy Drugs...
K190876 · LZA
Mercator Medical (Thailand), Ltd.
General Hospital · 242d
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