10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BLUE POWDERED LATEX EXAMINATION GLOVES, NON-STERILE
FDA 510(k)
FDA Class 1
·General Hospital
BIOTEQUE SCALP VEIN SET
FDA 510(k)
FDA Class 2
·General Hospital
BINDER CO2 INCUBATOR SERIE CB
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 14, 2025
20 G X 1.16 IN. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·July 10, 2017
UNKNOWN DEPUY ASR CUP
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·April 17, 2013
AMPLATZER SEPTAL OCCLUDER
FDA Adverse Event
Injury
·AGA MEDICAL CORPORATION·Product code MLV·June 20, 2008
ROTATING MULTIPLE CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·April 19, 2011
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