16 results
·
28ms
·
Sources: EU EUDAMED, US FDA
SAF-T-SYRINGE- 0.5 AND 1ML/CC
FDA 510(k)
FDA Class 2
·General Hospital
Sklar®
FDA UDI
SKLAR CORPORATION·10649111217319·TROEMNER HAMMER 9 1/2"
OBC-149 BREAST ARRAY COIL
FDA 510(k)
FDA Class 2
·Radiology
RT-PLUS KNEE ADDITIONAL COMPONENTS
FDA 510(k)
FDA Class 2
·Orthopedic
ARIS TRANS-OBTURATOR SLING
FDA Adverse Event
Injury
·COLOPLAST A/S·Product code OTN·November 6, 2019
HELICAL BLADE COUPLING SCREW
FDA Adverse Event
Malfunction
·SYNTHES BRANDYWINE·Product code LXH·April 17, 2013
ACCU-CHEK ULTRAFLEX INFUSION SET
FDA Adverse Event
Injury
·DISETRONIC MEDICAL SYSTEMS·Product code FPA·June 19, 2008
IN TOUCH ZU
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
CORMATRIX ECM FOR PERICARDIAL CLOSURE
FDA Adverse Event
Injury
·CORMATRIX CARDIOVASCULAR, INC.·Product code DXZ·July 19, 2013
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