10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KAVS - CATHETER, MODELS 1107100 & 1107060
FDA 510(k)
FDA Class 2
·Cardiovascular
SYNTHES RESORBABLE CONTOURABLE MESH
FDA 510(k)
FDA Class 2
·Dental
MAROSIS PACS
FDA 510(k)
FDA Class 2
·Radiology
BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC
FDA Adverse Event
Malfunction
·BD SUZHOU (MDS)·Product code FOZ·July 25, 2024
BD INTIMA-II CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·July 10, 2023
12/14 ARTICUL 40MM M SPEC+5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·April 11, 2013
POWEHEART AED
FDA Adverse Event
Malfunction
·CARDIAC SCIENCE CORPORATION·Product code MKJ·May 27, 2008
VITALITY 2
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 13, 2011
INFUSE BONE GRAFT/LT-CAGE
FDA Adverse Event
Injury
·MEDTRONIC·Product code NEK·November 12, 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