Search Results
Found 96980 results
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
Intended Use
Device Description
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
Intended Use
Device Description
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
Intended Use
Device Description
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
Intended Use
Device Description
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
Intended Use
Device Description
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
Intended Use
Device Description
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
Intended Use
Device Description
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
Intended Use
Device Description
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
Intended Use
Device Description
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
Intended Use
Device Description
K Number
K251339Device Name
Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04)
Manufacturer
Zhengzhou PZ Laser Slim Technology Co., Ltd.
Date Cleared
2025-07-25
(86 days)
Product Code
GEX
Regulation Number
878.4810AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
K Number
K251620Device Name
A.L.P.S. Proximal Humerus Plating System
Manufacturer
Zimmer Biomet
Date Cleared
2025-07-25
(59 days)
Product Code
HRS
Regulation Number
888.3030AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
K Number
K251665Device Name
Triathlon® Hinge Knee System
Manufacturer
Howmedica Osteonics Corp. dba Stryker Orthopaedics
Date Cleared
2025-07-25
(56 days)
Product Code
KRO
Regulation Number
888.3510AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
K Number
K252033Device Name
Profoject Disposable Syringe, Profoject Disposable Syringe with Needle
Manufacturer
CMT HEALTH PTE. LTD.
Date Cleared
2025-07-25
(25 days)
Product Code
FMF
Regulation Number
880.5860AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
K Number
K252215Device Name
InbellaMAX System
Manufacturer
Inbella Medical Ltd.
Date Cleared
2025-07-25
(10 days)
Product Code
GEI
Regulation Number
878.4400AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
K Number
K243392Device Name
Infusomat® Space Volumetric Infusion Pump Administration Sets
Manufacturer
B. Braun Medical Inc
Date Cleared
2025-07-24
(266 days)
Product Code
FPA
Regulation Number
880.5440AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
K Number
K243711Device Name
Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System (BrightP960); Confocal Microprobe Imaging System (BrightP880); Confocal Microprobe Imaging System (BrightP860); Confocal Microprobe Imaging System (BrightP780); Confocal Microprobe Imaging System (BrightP750); Confocal Microprobe Imaging System (BrightP680); Confocal Microprobe Imaging System (BrightP660); Confocal Microprobe Imaging System (BrightP600); Confocal Microprobe Imaging System (BrightP580);
Manufacturer
Wuxi Hisky Medical Technologies Co., Ltd.
Date Cleared
2025-07-24
(234 days)
Product Code
OWN
Regulation Number
876.1500AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
K Number
K250284Device Name
TSK SELECT Needle
Manufacturer
TSK Laboratory, Japan
Date Cleared
2025-07-24
(174 days)
Product Code
FMI
Regulation Number
880.5570AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
K Number
K250322Device Name
Respond OC Conserving Regulator (130-0800)
Manufacturer
Responsive Respiratory
Date Cleared
2025-07-24
(170 days)
Product Code
NFB
Regulation Number
868.5905AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
K Number
K251297Device Name
MIS LYNX Conical Connection Implant System
Manufacturer
Dentsply Sirona Inc.
Date Cleared
2025-07-24
(87 days)
Product Code
N/A
Regulation Number
N/AAI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Page 1 of 4849