12 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ORTHOMAP 3D 1.1 MODULE
FDA 510(k)
FDA Class 2
·Neurology
LEONE SPA
FDA UDI
LEONE SPA·08033707065814·EXTRAORAL ELASTICS 3/16" 8 oz
LEONE SPA
FDA UDI
LEONE SPA·08033707065746·INTRAORAL ELASTICS 6,5 oz 1/4" red
GLIASITE RADIATION THERAPY SYSTEM (RTS), MODEL 1020,1030,1040,8150,9005
FDA 510(k)
FDA Class 2
·Radiology
TINA-QUANT APOLIPOPROTEIN B VER.2
FDA 510(k)
FDA Class 2
·Immunology
MEDACTA KNEE IMPLANTS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·January 28, 2016
5.0MM FLEXIBLE SHAFT
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HTO·May 4, 2013
PRESSURE INFUSION BAG
FDA Adverse Event
Malfunction
·MERIT MEDICAL SYSTEMS, INC.·Product code KZD·August 21, 2014
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMS INNOVATION CENTER - SILICON VALLEY·Product code GEX·May 3, 2011
C8701, S ALEXIS LAP SYS W/ KII FIOS 5/BX
FDA Adverse Event
Malfunction
·APPLIED MEDICAL RESOURCES·Product code GCJ·November 14, 2016
CATH.GUIDE 5F JR 4.0 110CM CATHETER LA5JR40A LA 5F 110CM JR4.0 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Model #LA5JR40A
FDA Recall
Terminated
·Medtronic, Inc.·Product code DQY·April 5, 2006
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