Search FDA 510(k) Devices

5,373 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: 2025–2025 ×
3,225 results
49–72 of 3,225
Cleared Dec 23, 2025
Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)
K251268 · IYN
Edan Instruments, Inc.
Radiology · 243d
Cleared Dec 23, 2025
NizPlant Dental Implant System
K250476 · DZE
Paragon Implant Mfg., LLC
Dental · 307d
Not Cleared Dec 23, 2025
LIAISON® XL MUREX Anti-HDV (318260)
DEN250032 · SGW
DiaSorin, Inc.
Microbiology · 146d
Not Cleared Dec 23, 2025
QIKCAP System
DEN250004 · SGX
Hai Solutions
General Hospital · 327d
Cleared Dec 22, 2025
InnoClip Disposable Clip Applier
K253903 · FZP
Taiwan Surgical Corporation
General & Plastic Surgery · 17d
Cleared Dec 22, 2025
HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)
K253876 · OVE
Globus Medical, Inc.
Orthopedic · 18d
Cleared Dec 22, 2025
InnoClip Clip Applier
K253781 · FZP
Taiwan Surgical Corporation
General & Plastic Surgery · 26d
Cleared Dec 22, 2025
Instylla Delivery Kit
K253769 · FMF
Instylla, Inc.
General Hospital · 27d
Cleared Dec 22, 2025
Syndesmosis TightRope PRO
K253727 · HTN
Arthrex, Inc.
Orthopedic · 28d
Cleared Dec 22, 2025
SKOUT system
K253664 · QNP
Iterative Health
Gastroenterology & Urology · 32d
Cleared Dec 22, 2025
TMINI Miniature Robotic System
K253661 · OLO
THINK Surgical, Inc.
Orthopedic · 32d
Cleared Dec 22, 2025
Theracor
K253339 · KGN
Stimlabs, LLC
General & Plastic Surgery · 83d
Cleared Dec 22, 2025
Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G)
K253222 · MMK
Zhejiang Gongdong Medical Technology...
General Hospital · 84d
Cleared Dec 22, 2025
EmbraceMini
K252981 · LEL
Empatica S.R.L.
Neurology · 96d
Cleared Dec 22, 2025
PeekMed web
K252856 · QIH
Peek Health, S.A.
Radiology · 104d
Cleared Dec 22, 2025
STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device
K252743 · GAM
Ethicon, Inc.
General & Plastic Surgery · 116d
Cleared Dec 22, 2025
LacertaMatrix
K252673 · KGN
Lacerta Life Science
General & Plastic Surgery · 119d
Cleared Dec 22, 2025
Portable oxygen concentrator (JLO-190P)
K252616 · CAW
Shenzhen Homed Medical Device Co., Ltd.
Anesthesiology · 125d
Cleared Dec 22, 2025
aprevo® cervical plating system
K252611 · KWQ
Carlsmed, Inc.
Orthopedic · 126d
Cleared Dec 22, 2025
Lumify Diagnostic Ultrasound System
K252557 · IYN
Philips Ultrasound, LLC
Radiology · 131d
Cleared Dec 22, 2025
AccurECG Analysis System (v2.0)
K252361 · DPS
Accurkardia, Inc.
Cardiovascular · 146d
Cleared Dec 22, 2025
RayStation (2024A SP3)
K252109 · MUJ
RaySearch Laboratories AB (PUBL)
Radiology · 168d
Cleared Dec 22, 2025
MC2 Portable X-ray System
K252068 · OWB
Oxos Medical
Radiology · 174d
Cleared Dec 22, 2025
Inspire HCR and HCR DUAL cardiotomy reservoirs
K251783 · DTN
Sorin Group Italia S.R.L.
Cardiovascular · 194d