16 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TOP FINE INSULIN SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
MODIFICATION TO: ERBE APC CONNECTOR HOSE AND PROBES, MODELS 20132-158, 20132-155, 20132-156, 20132-157, 20132-166
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
E.N.S.I. RETRACTABLE SAFETY SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
PROCISE XP
FDA Adverse Event
Malfunction
·ARTHROCARE CORPORATION·Product code GEI·April 11, 2013
CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code KRH·June 19, 2008
GO BED PLUS
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·April 11, 2011
CORMATRIX ECM FOR PERICARDIAL CLOSURE
FDA Adverse Event
Injury
·CORMATRIX CARDIOVASCULAR, INC.·Product code DXZ·October 26, 2011
CORMATRIX ECM FOR PERICARDIAL CLOSURE
FDA Adverse Event
Injury
·CORMATRIX CARDIOVASCULAR, INC.·Product code DXZ·October 30, 2013
OSSEOTITE CERTAIN IMPLANT 4 X 11.5MM
FDA Adverse Event
Injury
·BIOMET 3I·Product code DZE·December 18, 2023
CORMATRIX ECM FOR PERICARDIAL CLOSURE
FDA Adverse Event
Injury
·CORMATRIX CARDIOVASCULAR, INC.·Product code DXZ·April 14, 2015
CORMATRIX ECM FOR PERICARDIAL CLOSURE
FDA Adverse Event
Injury
·CORMATRIX CARDIOVASCULAR, INC.·Product code DXZ·May 7, 2010
KYPHON KURVE BONE FILLER DEVICE 13GA
FDA Adverse Event
Malfunction
·MEDTRONIC MEXICO·Product code KIH·July 14, 2020
CORMATRIX ECM FOR PERICARDIAL CLOSURE
FDA Adverse Event
Injury
·CORMATRIX CARDIOVASCULAR, INC.·Product code DXZ·July 19, 2013
Optical Access System; 5mm x 100mm and 12mm x 100mm; Model #: CTR03 and CTR73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·July 1, 2015
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