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Found 96980 results
510(k) Data Aggregation
K Number
K243244Device Name
Heated Breathing Tube
Manufacturer
GuangDong EDA Technology Co., Ltd
Date Cleared
2025-07-25
(287 days)
Product Code
BZE
Regulation Number
868.5270AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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K Number
K243403Device Name
BD Nexiva Closed IV Catheter System
Manufacturer
Becton Dickinson Infusion Therapy Systems Inc.
Date Cleared
2025-07-25
(267 days)
Product Code
FOZ
Regulation Number
880.5200AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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K Number
K250232Device Name
Vathin® Video Bronchoscope System
Manufacturer
Hunan Vathin Medical Instrument Co., Ltd.
Date Cleared
2025-07-25
(179 days)
Product Code
EOQ
Regulation Number
874.4680AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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K Number
K250244Device Name
Compression Therapy Device (LGT-2210DS)
Manufacturer
Guangzhou Longest Medical Technology Co., Ltd.
Date Cleared
2025-07-25
(179 days)
Product Code
IRP
Regulation Number
890.5650AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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K Number
K250334Device Name
Fusion Craniofacial Implant; Fusion Skull Implant
Manufacturer
Kelyniam Global Inc.
Date Cleared
2025-07-25
(170 days)
Product Code
GWO
Regulation Number
882.5320AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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K Number
K250552Device Name
Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire
Manufacturer
Abbott Medical
Date Cleared
2025-07-25
(150 days)
Product Code
DQX
Regulation Number
870.1330AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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K Number
K250859Device Name
TransForm McCarthy Mitral Annuloplasty Ring (TF)
Manufacturer
Genesee Biomedical Inc
Date Cleared
2025-07-25
(126 days)
Product Code
KRH
Regulation Number
870.3800AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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K Number
K250970Device Name
Marie
Manufacturer
Leo Cancer Care
Date Cleared
2025-07-25
(116 days)
Product Code
JAK
Regulation Number
892.1750AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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K Number
K250989Device Name
Stryker and Serf hip devices
Manufacturer
Howmedica Osteonics Corp (dba Stryker Orthopaedics)
Date Cleared
2025-07-25
(116 days)
Product Code
LPH, HWC, KWZ, LZO, MAY, MBL, MEH
Regulation Number
888.3358AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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K Number
K251322Device Name
Venue; Venue Go; Venue Fit; Venue Sprint
Manufacturer
GE Medical Systems Ultrasound and Primary care Diagnostics,
Date Cleared
2025-07-25
(87 days)
Product Code
IYN, ITX, IYO
Regulation Number
892.1550AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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