Search Results
Found 96866 results
K Number
K243598Device Name
Welch Allyn Connex® 360 (Multiple)
Manufacturer
Welch Allyn, Inc.
Date Cleared
2025-07-13
Product Code
N/A
Regulation Number
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
K Number
K243199Device Name
NightWatch+ US
Manufacturer
LivAssured BV
Date Cleared
2025-07-12
Product Code
POS
Regulation Number
882.1580
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
K Number
K241179Device Name
Rhythm Express Remote Cardiac Monitoring System (RX-1 mini)
Manufacturer
VivaQuant, Inc.
Date Cleared
2025-07-11
Product Code
MLO
Regulation Number
870.2800
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
K Number
K243227Device Name
B-Scan
Manufacturer
ACCUTOME, INC. Doing Business As Keeler USA
Date Cleared
2025-07-11
Product Code
IYO
Regulation Number
892.1560
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
K Number
K243274Device Name
CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A SubTyping Kit (VER 4); Influenza B Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4)
Manufacturer
Centers for Disease Control and Prevention
Date Cleared
2025-07-11
Product Code
OZE
Regulation Number
866.3980
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
K Number
K243296Device Name
Disposable Biopsy Needle
Manufacturer
Carbon (Shenzhen) Medical Device Co., Ltd.
Date Cleared
2025-07-11
Product Code
KNW
Regulation Number
876.1075
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
K Number
K243655Device Name
TurbAlign
Manufacturer
Spirair, Inc
Date Cleared
2025-07-11
Product Code
LYA
Regulation Number
874.4780
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
K Number
K250034Device Name
Natural rubber latex male condom
Manufacturer
Shaoguan Regenex Pharmaceuticals Co., Ltd.
Date Cleared
2025-07-11
Product Code
HIS
Regulation Number
884.5300
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
K Number
K250156Device Name
Choice 2 DC
Manufacturer
Bisco, Inc
Date Cleared
2025-07-11
Product Code
EMA
Regulation Number
872.3275
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
K Number
K250266Device Name
Ceragem Automatic Thermal Massager (CGM MB-2401)
Manufacturer
CERAGEM Co, Ltd.
Date Cleared
2025-07-11
Product Code
JFB, IRO, IRP, ISA
Regulation Number
890.5880
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
K Number
K250671Device Name
FreeStyle Comfort (AS200 / FreeStyle Comfort)
Manufacturer
CAIRE Inc.
Date Cleared
2025-07-11
Product Code
CAW
Regulation Number
868.5440
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
K Number
K250761Device Name
KALA Therapy Wand (Model: KALA-03)
Manufacturer
SHENZHEN KAIYAN MEDICAL EQUIPMENT CO., LTD
Date Cleared
2025-07-11
Product Code
OHS, ISA, OLP
Regulation Number
878.4810
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
K Number
K250762Device Name
ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R)
Manufacturer
Olympus Medical Systems Corporation
Date Cleared
2025-07-11
Product Code
ITX
Regulation Number
892.1570
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
K Number
K250772Device Name
Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheter
Manufacturer
Surgical Instrument Service and Savings Inc.
Date Cleared
2025-07-11
Product Code
NLH
Regulation Number
870.1220
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
K Number
K250820Device Name
Disposable Trocars
Manufacturer
Sinolinks Medical Innovation, Inc.
Date Cleared
2025-07-11
Product Code
GCJ
Regulation Number
876.1500
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
K Number
K250942Device Name
Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK, UI20 DB, UI20 RE, UI20 PW, UI20 GP, UI20 GR, UI20 BK)
Manufacturer
Shenzhen Ulike Smart Electronics Co., Ltd.
Date Cleared
2025-07-11
Product Code
OHT
Regulation Number
878.4810
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
K Number
K251134Device Name
RipCord
Manufacturer
TriMed, Inc.
Date Cleared
2025-07-11
Product Code
HTN
Regulation Number
888.3030
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
K Number
K251149Device Name
AviClear Laser System
Manufacturer
Cutera, Inc.
Date Cleared
2025-07-11
Product Code
GEX
Regulation Number
878.4810
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
K Number
K251155Device Name
BD Cathena Safety IV Catheter
Manufacturer
Becton Dickinson Infusion Therapy Systems Inc.
Date Cleared
2025-07-11
Product Code
FOZ
Regulation Number
880.5200
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
K Number
K251352Device Name
Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series enabled to retrofit RFID features); Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-1, SLS XXX, Multiple Models Pending Configuration)
Manufacturer
Codonics.Incorporated
Date Cleared
2025-07-11
Product Code
BSZ
Regulation Number
868.5160
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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