12 results
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26ms
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Sources: EU EUDAMED, US FDA
SAMPLING KIT
FDA 510(k)
FDA Class 1
·Anesthesiology
ACUMED
FDA UDI
Acumed LLC·10806378047015·Offset Adjustable Handle Clamp
NAR Kit
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209116935·KIT, REFLEX IFAK SYSTEM - ADVANCED - MTC
PROFILE 8 FR. 40 CC. IAB WITH ACCESSORIES-DOMESTIC
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·September 23, 1998
GENYX FLEXIBLE INJECTION NEEEDLE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ECHELON ENDOSCOPIC LINEAR CUTTERS (ARTICULATING AND STRAIGHT)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SENSOR ENLITE
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OZO·May 8, 2014
M2A-MAGNUM MODULAR HEAD SZ 58MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·October 23, 2012
BIOLOX DELTA CER HEAD 40 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·May 26, 2015
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