14 results
·
22ms
·
Sources: EU EUDAMED, US FDA
ANOVA CONTAINMENT DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NLITE SYSTEM,MODEL A00-1025
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
DREAMSTATION AUTO CPAP
FDA Adverse Event
Malfunction
·RESPIRONICS,INC·Product code BZD·February 28, 2022
ERBE
FDA Adverse Event
Malfunction
·LEONHARD LANG GMBH·Product code GEI·October 21, 2020
KLS MARTIN
FDA Adverse Event
Malfunction
·LEONHARD LANG GMBH·Product code GEI·November 17, 2020
ACCU-CHEK ® COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·April 17, 2013
BLAKE DRAIN
FDA Adverse Event
Malfunction
·ETHICON, INC·Product code KOG·April 19, 2011
MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8IN (2
FDA Adverse Event
Injury
·ARROW INTL., INC.·Product code DQO·June 20, 2008
ERBE
FDA Adverse Event
Injury
·LEONHARD LANG GMBH·Product code GEI·October 23, 2024
ERBE
FDA Adverse Event
Malfunction
·LEONHARD LANG GMBH·Product code GEI·September 20, 2024
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
Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018