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Found 96980 results

K Number
K243244
Device Name
Heated Breathing Tube
Manufacturer
GuangDong EDA Technology Co., Ltd
Date Cleared
2025-07-25

(287 days)

Product Code
BZE
Regulation Number
868.5270
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
K Number
K243403
Device 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
880.5200
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
K Number
K250232
Device Name
Vathin® Video Bronchoscope System
Manufacturer
Hunan Vathin Medical Instrument Co., Ltd.
Date Cleared
2025-07-25

(179 days)

Product Code
EOQ
Regulation Number
874.4680
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
K Number
K250244
Device 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
890.5650
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
K Number
K250334
Device Name
Fusion Craniofacial Implant; Fusion Skull Implant
Manufacturer
Kelyniam Global Inc.
Date Cleared
2025-07-25

(170 days)

Product Code
GWO
Regulation Number
882.5320
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
K Number
K250552
Device 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
870.1330
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
K Number
K250859
Device Name
TransForm McCarthy Mitral Annuloplasty Ring (TF)
Manufacturer
Genesee Biomedical Inc
Date Cleared
2025-07-25

(126 days)

Product Code
KRH
Regulation Number
870.3800
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
K Number
K250970
Device Name
Marie
Manufacturer
Leo Cancer Care
Date Cleared
2025-07-25

(116 days)

Product Code
JAK
Regulation Number
892.1750
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
K Number
K250989
Device 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
888.3358
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
K Number
K251322
Device 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
892.1550
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
K Number
K251339
Device 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
878.4810
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
K Number
K251620
Device Name
A.L.P.S. Proximal Humerus Plating System
Manufacturer
Zimmer Biomet
Date Cleared
2025-07-25

(59 days)

Product Code
HRS
Regulation Number
888.3030
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
K Number
K251665
Device Name
Triathlon® Hinge Knee System
Manufacturer
Howmedica Osteonics Corp. dba Stryker Orthopaedics
Date Cleared
2025-07-25

(56 days)

Product Code
KRO
Regulation Number
888.3510
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
K Number
K252033
Device 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
880.5860
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
K Number
K252215
Device Name
InbellaMAX System
Manufacturer
Inbella Medical Ltd.
Date Cleared
2025-07-25

(10 days)

Product Code
GEI
Regulation Number
878.4400
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
K Number
K243392
Device 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
880.5440
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
K Number
K243711
Device 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
876.1500
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
K Number
K250284
Device Name
TSK SELECT™ Needle
Manufacturer
TSK Laboratory, Japan
Date Cleared
2025-07-24

(174 days)

Product Code
FMI
Regulation Number
880.5570
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
K Number
K250322
Device Name
Respond OC Conserving Regulator (130-0800)
Manufacturer
Responsive Respiratory
Date Cleared
2025-07-24

(170 days)

Product Code
NFB
Regulation Number
868.5905
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
K Number
K251297
Device 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/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description

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