21 results
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23ms
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Sources: EU EUDAMED, US FDA
CRPEX CRP CONTROLS LEVEL L, M, H; CAT. NO.: 3011, 3012, 3013
FDA 510(k)
FDA Class 1
·Clinical Chemistry
HairCheck-DT (Opiates)
FDA UDI
Quest Diagnostics·00868586000223·HairCheck-DT (Opiates) is an ELISA test kit use...
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496022725·WONDER MODEL 70, SIZE M, MOKA, GRADUATED COMPRE...
MedGyn IUI
FDA UDI
MEDGYN PRODUCTS, INC.·M803022725·iui mini curved
COATED VICRYL PLUS ANTIBACTERIAL SUTURE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code GAM·April 20, 2006
COATED VICRYL PLUS ANTIBACTERIAL SUTURE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code GAM·April 20, 2006
COATED VICRYL PLUS ANTIBACTERIAL SUTURE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code GAM·April 20, 2006
COATED VICRYL PLUS ANTIBACTERIAL SUTURE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code GAM·April 20, 2006
MICROPAQ, MODELS 402 AND 404
FDA 510(k)
FDA Class 2
·Cardiovascular
TISSUE GRASPING FORCEPS, SCISSORS, CLAMPS AND DISSECTORS FOR LAPAROSCOPIC SURGERIES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
COATED VICRYL PLUS ANTIBACTERIAL SUTURE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code GAM·April 25, 2006
COATED VICRYL PLUS ANTIBACTERIAL SUTURE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code GAM·April 21, 2006
PULSE-GENERATOR, PACEMAKER, IMPLANTABLE
FDA Adverse Event
Death
·RICE CREEK MFG·Product code DXY·March 27, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·March 17, 2011
PROGRAMMING SOFTWARE
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·March 27, 2008
OT SURESTEP METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·March 31, 2011
OT SURESTEP ENHANCED METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·August 23, 2011
OT SS ENHANCED METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·April 11, 2011
OT SS ENHANCED METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·October 14, 2010
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