13 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Trevo XP ProVue Retriever and Trevo NXT ProVue Retriever
FDA 510(k)
FDA Class 2
·Neurology
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114179·KRATZ POLISHER 23GA SIDE (PK/10)
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114186·KRATZ POLISHER 21GA SIDE (PK/10)
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114193·OLIVE POLISHER 23G ANG 10MM
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·February 4, 2020
HARALD NORDIN CARBONITE CARBON FIBER COMPOSITE DENTAL POST
FDA 510(k)
FDA Class 1
·Dental
BECTON DICKINSON DIABETES SOFTWARE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SYNCHROMED II
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LKK·October 17, 2008
ENRHYTHM DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DXY·August 11, 2011
TOTAL ASR ACET IMP SIZE 50
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code KWA·July 2, 2013
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
paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024
smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024