13 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System
FDA 510(k)
FDA Class 2
·Cardiovascular
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114155·KRATZ POLISHER 23GA END (PK/10)
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668113837·VISCO CANNULA 23GA ANGLE 8MM
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114162·ROBINS-KRATZ POLISHING CAN, 22GA PK/10
R & D 3K RETIC
FDA 510(k)
FDA Class 2
·Hematology
CEDIA CYCLOSPORINE PLUS ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
HEARTSTRING II PROXIMAL SEAL SYSTEM
FDA Adverse Event
Malfunction
·GUIDANT CARDIAC SURGERY·Product code DXC·October 17, 2008
ADULT BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·August 11, 2011
COULTER® AC*T DIFF 2 ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·July 2, 2013
CERAMAX CERAMIC INSERT 36 X 54
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code MRA·April 2, 2019
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·April 30, 2025
LUMENIS PULSE120H
FDA Adverse Event
Malfunction
·LUMENIS LTD.·Product code GEX·November 27, 2019
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012