18 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DENSICHEK PLUS
FDA 510(k)
FDA Class 2
·Microbiology
K083526
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code CBK·May 7, 2018
HARDYDISK NAFCILLIN, 1 MCG
FDA 510(k)
FDA Class 2
·Microbiology
EMTRAC; DELPHIN; SEMTRAC 2000 SET
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ACCU-CHEK ® INSIGHT CARTRIDGE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LZG·March 26, 2015
METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 48, 42,CODE H
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·June 19, 2018
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
JUMAO MEDICAL EQUIPMENT·Product code IOR·April 29, 2013
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS DE MEXICO.·Product code NIQ·July 23, 2008
ECHELON*FLEX60
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC (CINCINNATI)·Product code GDW·May 10, 2011
METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 54, 48, CODE N
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·March 28, 2019
UNKNOWN
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·July 26, 2024
METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 50, 44, CODE J
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·February 20, 2018
METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 50, 44, CODE J
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·February 20, 2018
METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 46/ 40, CODE F
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·June 13, 2018
METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 62/56, CODE V
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·January 31, 2018
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014
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
Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018