11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MONOLISA ANTI-HAV IGM EIA
FDA 510(k)
FDA Class 2
·Microbiology
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·February 14, 2025
NONIN MODEL 2120 PULSE OXIMETER AND NONINVASIVE BLOOD PRESSURE (NIBP) MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
NUVASIVE MASH
FDA 510(k)
FDA Class 2
·Orthopedic
LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code LDD·December 4, 2012
ALINITY I HAVAB IGM REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LOL·March 26, 2026
CONSTELLATION VISION SYSTEM
FDA Adverse Event
Malfunction
·ALCON MANUFACTURING, LTD.·Product code HQC·March 1, 2013
ECLIPSE FILTER SYSTEM - FEMORAL
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·April 11, 2011
PUMP MMT-512LNAL PRDGM INS CL EN US LN
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code LZG·June 18, 2008
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
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015