17 results
·
22ms
·
Sources: EU EUDAMED, US FDA
WIRELESS BODY TEMPERATURE MONITOR, MODELS BTM-DIC, D, E, F, G AND H
FDA 510(k)
FDA Class 2
·General Hospital
TORIC LITE LENS
FDA 510(k)
FDA Class 2
·Ophthalmic
CONTROL PLASMA N
FDA 510(k)
FDA Class 2
·Hematology
SMARTMONITOR 2 PS
FDA Adverse Event
Malfunction
·PHILLIPS RESPIRONICS - CHMV·Product code FLS·February 21, 2014
WAVEWRITER ALPHA? 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·December 5, 2025
SMART MONITOR 2 PS
FDA Adverse Event
Malfunction
·PHILIPS RESPIRONICS -CHMV·Product code NPF·August 26, 2014
WAVEWRITER ALPHA? PRIME 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·April 30, 2026
CADD MEDICATION CASSETTE
FDA Adverse Event
Malfunction
·NULL·Product code FPA·February 4, 2022
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·April 26, 2013
MODEL NOT SPECIFIED
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code LZG·April 26, 2011
MICROSTAAR INJECTOR
FDA Adverse Event
Injury
·STAAR SURGICAL CO.·Product code MSS·July 24, 2008
SMARTMONITOR 2 PROFESSIONAL SERIES
FDA Adverse Event
Malfunction
·PHILIPS RESPIRONICS - CHMV·Product code FLS·August 23, 2013
SMART MONITOR 2 PS
FDA Adverse Event
Malfunction
·PHILIPS RESPIRONICS - CHMV·Product code NPF·May 30, 2013
SMART MONITOR 2 PS
FDA Adverse Event
Malfunction
·PHILIPS RESPIRONICS - CHMV·Product code NPF·September 4, 2013
SMART MONITOR 2 PS
FDA Adverse Event
Malfunction
·PHILIPS RESPIRONICS - CHMV·Product code NPF·October 11, 2013
Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
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