12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PORTEX HYPODERMIC NEEDLE-PRO FIXED NEEDLE SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
SYRINGE 0.3ML 31GA 8MM 10BAG 500 PL/WG
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·October 9, 2019
CONCERT RADIOPAQUE BONE CEMENT
FDA 510(k)
FDA Class 2
·Orthopedic
MEDLINE BLOCKADE OR RESISTAT SURGICAL GOWNS AND SURGGICAL DRAPES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SYRINGE 0.3ML 31GA 8MM 10BAG 500 PL/WG
FDA Adverse Event
Injury
·BD MEDICAL - DIABETES CARE·Product code FMF·October 31, 2019
CP87170 DE MUENCHEN
FDA Adverse Event
Death
·SORIN GROUP ITALIA·Product code DTZ·July 15, 2011
R SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·April 3, 2013
ACRYSOF IQ TORIC
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·April 14, 2011
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
FDA Adverse Event
Malfunction
·STAAR SURGICAL·Product code MTA·June 19, 2008
DIMENSION VISTA®
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code MMI·August 28, 2018
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