Search FDA 510(k) Devices

5,735 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
3889–3912 of 174,061
Cleared Jan 08, 2025
Sperm Freezing Medium
K242043 · MQL
Gimbo Medical Technology Shenzhen...
Obstetrics & Gynecology · 180d
Cleared Jan 08, 2025
Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel
K241806 · QOF
Life Technologies Corporation
Microbiology · 201d
Cleared Jan 08, 2025
ReminGel
K241489 · LBH
Inter-Med, Inc.
Dental · 229d
Cleared Jan 08, 2025
HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)
K241003 · NHA
Hiossen, Inc.
Dental · 271d
Cleared Jan 08, 2025
Electrical Scooter, WT-T4SU
K240590 · INI
W'U'S Tech Co., Ltd.
Physical Medicine · 313d
Cleared Jan 07, 2025
Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit...
K243335 · LNH
Canon Medical Systems Corporation
Radiology · 75d
Cleared Jan 07, 2025
MASADA Modular Spinal Fixation System
K243259 · NKB
Astura Medical
Orthopedic · 84d
Cleared Jan 07, 2025
COREPASS Modular Microcatheter (FLEX)
K242588 · DQY
OrbusNeich Medical (Shenzhen) Co., Ltd.
Cardiovascular · 130d
Cleared Jan 07, 2025
GXR-Series Diagnostic X-Ray System
K242019 · KPR
DRGEM Corporation
Radiology · 181d
Cleared Jan 07, 2025
ApolloHipX (THR.SS.0001)
K241808 · LLZ
Corin U.S.A. Limited
Radiology · 200d
Cleared Jan 07, 2025
GlutenID Celiac Genetic Health Risk Test
K241456 · PTA
Targeted Genomics, LLC
Immunology · 230d
Cleared Jan 07, 2025
uCT 780
K241079 · JAK
Shanghai United Imaging Healthcare...
Radiology · 263d
Cleared Jan 06, 2025
TMINI Miniature Robotic System
K243481 · OLO
THINK Surgical, Inc.
Orthopedic · 59d
Cleared Jan 06, 2025
Conformity Stem Extension Line, #0
K243466 · LZO
United Orthopedic Corporation
Orthopedic · 59d
Cleared Jan 06, 2025
WHILL Model R
K242760 · INI
Whill, Inc.
Physical Medicine · 116d
Cleared Jan 06, 2025
SD TL Implant System
K242753 · DZE
Arum Dentistry Co., Ltd.
Dental · 116d
Cleared Jan 06, 2025
Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E))
K242499 · KPR
Shenzhen?Sontu?Medical?Imaging?Equipm...
Radiology · 137d
Cleared Jan 06, 2025
Soteria E-View
K242488 · JAA
Omega Medical Imaging, LLC
Radiology · 138d
Cleared Jan 06, 2025
Mobility Scooter (YL-09B, YL-07)
K242139 · INI
Yongkang Yile Vehicle Co., Ltd.
Neurology · 168d
Cleared Jan 06, 2025
Brainomix 360 e-CTA
K242123 · LLZ
Brainomix Limited
Radiology · 171d
Cleared Jan 06, 2025
DermiSphere Dermal Template
K241904 · KGN
Fesariustherapeutics, Inc.
General & Plastic Surgery · 189d
Cleared Jan 03, 2025
Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™...
K250015 · DYH
Ormco Corporation
Dental · 1d
Cleared Jan 03, 2025
Inbella RF System
K243737 · GEI
Inbella Medical, Inc.
General & Plastic Surgery · 30d
Cleared Jan 03, 2025
JLK-ICH
K243363 · QAS
JLK, Inc.
Radiology · 66d