Search FDA 510(k) Devices

5,396 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
793–816 of 174,061
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
Cleared Dec 22, 2025
Oxygen Concentrator-P2-O5E
K251764 · CAW
Qingdao Kingon Medical Science and...
Anesthesiology · 196d
Cleared Dec 22, 2025
DIMPLO Implant System
K251605 · DZE
DIMPLO, Ltd.
Dental · 209d
Cleared Dec 22, 2025
Power wheelchair
K251159 · ITI
Zhenjiang Assure Medical Equipment...
Physical Medicine · 251d
Cleared Dec 22, 2025
Tetra (TM-20)
K251105 · PKP
Emed Technologies Corporation
General Hospital · 255d
Cleared Dec 22, 2025
BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G
K251019 · FGE
Bioteque Corporation
Gastroenterology & Urology · 264d
Cleared Dec 22, 2025
BioticsAI
K250959 · IYN
Bioticsai, Inc.
Radiology · 266d
Cleared Dec 22, 2025
Pression Wave PRO External Counter-Pulsation System
K250756 · DRN
Pression, Inc.
Cardiovascular · 285d
Cleared Dec 22, 2025
KP Protective Face Mask
K243342 · FXX
Kp Trading Co., Ltd.
General Hospital · 423d
Cleared Dec 19, 2025
iCEM Universal Plus
K254063 · EMA
Kulzer, LLC
Dental · 2d
Cleared Dec 19, 2025
STAR Apollo™ Mapping System
K253733 · DQK
Rhythm AI, Ltd.
Cardiovascular · 25d
Cleared Dec 19, 2025
ProtekDilate Vascular Access Kit
K253616 · DRE
Sorin Group Italia S.R.L.
Cardiovascular · 31d
Cleared Dec 19, 2025
Monkey Rings External Ring Fixation System
K253613 · KTT
Paragon 28, Inc.
Orthopedic · 31d