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Found 96925 results

K Number
K250913
Device Name
TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System
Manufacturer
Jiangsu Tingsn Technology Co., Ltd.
Date Cleared
2025-07-19

(114 days)

Product Code
IYN, IYO, OBJ
Regulation Number
892.1550
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
K Number
K231562
Device Name
ELEC ENGINE (Model: ISE-170L)
Manufacturer
Micro-NX Co., Ltd.
Date Cleared
2025-07-18

(779 days)

Product Code
EBW
Regulation Number
872.4200
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
K Number
K243404
Device Name
HyHub™ and HyHub™ Duo Vial Access Devices
Manufacturer
Takeda Pharmaceuticals
Date Cleared
2025-07-18

(259 days)

Product Code
LHI
Regulation Number
880.5440
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
K Number
K243775
Device Name
True Non-Surgical Spinal Decompression System (DRX9000-SL)
Manufacturer
Excite Medical of Tampa Bay, LLC
Date Cleared
2025-07-18

(221 days)

Product Code
ITH
Regulation Number
890.5900
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
K Number
K250084
Device Name
MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL)
Manufacturer
Beckman Coulter, Inc.
Date Cleared
2025-07-18

(186 days)

Product Code
LTT, JWY, LRG, LTW
Regulation Number
866.1640
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
K Number
K250553
Device Name
Tomey Cornea/Anterior Segment OCT (CASIA2)
Manufacturer
TOMEY Corporation
Date Cleared
2025-07-18

(143 days)

Product Code
OBO
Regulation Number
886.1570
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
K Number
K250750
Device Name
INNOVISION-P5
Manufacturer
DK Medical Systems Co., Ltd
Date Cleared
2025-07-18

(128 days)

Product Code
IZL
Regulation Number
892.1720
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
K Number
K250902
Device Name
HeartFlow Analysis
Manufacturer
HeartFlow, Inc.
Date Cleared
2025-07-18

(114 days)

Product Code
PJA, LLZ, QIH
Regulation Number
870.1415
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
K Number
K250952
Device Name
Baby Gorilla®/Gorilla® Plating System
Manufacturer
Paragon 28 Inc
Date Cleared
2025-07-18

(112 days)

Product Code
N/A
Regulation Number
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
K Number
K250999
Device Name
V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System; V5 Diagnostic Ultrasound System; cV5 Diagnostic Ultrasound System; V4 Diagnostic Ultrasound System; cV4 Diagnostic Ultrasound System
Manufacturer
Samsung Medison Co., Ltd.
Date Cleared
2025-07-18

(108 days)

Product Code
IYN, ITX, IYO, LLZ, QIH
Regulation Number
892.1550
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
K Number
K251542
Device Name
InstaFAN
Manufacturer
OnePass Medical Ltd.
Date Cleared
2025-07-18

(59 days)

Product Code
ODG
Regulation Number
876.1500
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
K Number
K251585
Device Name
Profoject™ Enteral Feeding Syringe
Manufacturer
CMT Health PTE. Ltd.
Date Cleared
2025-07-18

(56 days)

Product Code
PNR
Regulation Number
876.5980
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
K Number
K251655
Device Name
VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1)
Manufacturer
Alafair Biosciences
Date Cleared
2025-07-18

(49 days)

Product Code
N/A
Regulation Number
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
K Number
K251809
Device Name
Arthrex FiberTak Suture Anchor
Manufacturer
Arthrex, Inc.
Date Cleared
2025-07-18

(36 days)

Product Code
MBI
Regulation Number
888.3040
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
K Number
K251906
Device Name
Z1 Hip System
Manufacturer
Zimmer, Inc.
Date Cleared
2025-07-18

(28 days)

Product Code
LZO, KWY, KWZ, LWJ, MEH
Regulation Number
888.3353
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
K Number
K252012
Device Name
SPY Cystoscope/Hysteroscope
Manufacturer
Stryker Endoscopy
Date Cleared
2025-07-18

(21 days)

Product Code
HIH, FAJ, NWB
Regulation Number
884.1690
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
K Number
K252218
Device Name
MF SC GEN2 Facial Toning System
Manufacturer
Micro Current Technology, Inc.
Date Cleared
2025-07-18

(3 days)

Product Code
NFO
Regulation Number
882.5890
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
K Number
K242505
Device Name
Elecsys Cortisol III
Manufacturer
Roche Diagnostics
Date Cleared
2025-07-17

(329 days)

Product Code
JFT
Regulation Number
862.1205
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
K Number
K243324
Device Name
Masimo O3 Regional Oximeter
Manufacturer
Masimo Corporation
Date Cleared
2025-07-17

(267 days)

Product Code
MUD
Regulation Number
870.2700
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
K Number
K243420
Device Name
HESTIA
Manufacturer
GENORAY Co., Ltd.
Date Cleared
2025-07-17

(255 days)

Product Code
MUE
Regulation Number
892.1715
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description

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