Search FDA 510(k) Devices

5,508 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: 2025–2025 ×
3,225 results
2257–2280 of 3,225
Cleared Apr 25, 2025
Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL)
K243570 · JLW
Siemens Healthcare Diagnostics
Chemistry · 158d
Cleared Apr 25, 2025
cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test
K243406 · QOF
Roche Molecular Systems, Inc.
Microbiology · 175d
Cleared Apr 25, 2025
cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test
K243400 · QOF
Roche Molecular Systems, Inc.
Microbiology · 176d
Cleared Apr 25, 2025
DHF 0.2 Hemoconcentrator (DHF 02)
K243264 · KDI
Sorin Group Italia S.R.L.
Gastroenterology & Urology · 192d
Cleared Apr 25, 2025
Infrared Thermometer
K243082 · FLL
Guangzhou Daxin Health Technology...
General Hospital · 207d
Cleared Apr 25, 2025
contact forte Alpha
K243041 · LXB
Bhm-Tech Produktionsgesellschaft Mbh
Ear, Nose, Throat · 210d
Cleared Apr 25, 2025
RFMagik Lite
K242469 · GEI
Agnes Medical Co., Ltd.
General & Plastic Surgery · 248d
Cleared Apr 25, 2025
Kosmos
K242321 · IYN
EchoNous, Inc.
Radiology · 262d
Cleared Apr 24, 2025
GO-PEN®
K250262 · FMF
Go-Pen Aps
General Hospital · 85d
Cleared Apr 24, 2025
Diode laser system (Night Universe
K250206 · GEX
Ivylaser (Beijing) Technology Co.,Ltd
General & Plastic Surgery · 90d
Cleared Apr 24, 2025
CO2 Laser System (CO2 Laser SST-L23)
K250183 · GEX
Zhuozhou Summer Star Technologies...
General & Plastic Surgery · 92d
Cleared Apr 24, 2025
Arm Blood Pressure Monitor (ARM-30H)
K250116 · DXN
Shenzhen AOJ Medical Technology Co.,...
Cardiovascular · 98d
Cleared Apr 24, 2025
Smart Check O2 (MA0236)
K250002 · CCL
Life Spark Medical, LLC
Anesthesiology · 112d
Cleared Apr 24, 2025
PeriCross™ Epicardial Access Kit
K243954 · DYB
Circa Scientific, Inc.
Cardiovascular · 122d
Cleared Apr 24, 2025
ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)
K243945 · KNW
SurGenTec, LLC
General & Plastic Surgery · 125d
Cleared Apr 24, 2025
da Vinci SP Surgical System (SP1098)
K243714 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 143d
Cleared Apr 24, 2025
Lung AI (LAI001)
K243239 · MYN
Exo, Inc.
Radiology · 196d
Cleared Apr 24, 2025
CanMINI Hand and Foot System
K242973 · HRS
Canwell Medical Co., Ltd.
Orthopedic · 210d
Cleared Apr 24, 2025
MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs
K242963 · LCJ
Mentor Worldwide, LLC
General & Plastic Surgery · 211d
Cleared Apr 24, 2025
Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)
K242514 · EKX
Shenzhen Rogin Medical Co., Ltd.
Dental · 244d
Cleared Apr 24, 2025
Sonu
K242214 · QZC
Sound Health Systems, Inc.
Ear, Nose, Throat · 269d
Cleared Apr 24, 2025
Freespira Breathing System
K233337 · SEN
Freespira, Inc.
Neurology · 573d
Cleared Apr 23, 2025
Nitrile Powder Free Examination Glove, Blue Tested for Use with 60...
K250944 · LZA
Gmp Medicare Sdn. Bhd.
General Hospital · 26d
Cleared Apr 23, 2025
Parietene™ Macroporous Mesh (PPM5050 )
K250869 · FTL
Sofradim Production
General & Plastic Surgery · 30d