17 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ACCUFIX RADIOLUCENT PELVIS AND BELLY BOARDS, ACCUFIX CANTILEVER HEAD BOARD WITH SHOULDER DEPRESSION, ACCUFIX RADIOLUCENT
FDA 510(k)
FDA Class 2
·Radiology
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032156·Baltic Denture System BDLoad Sw7 PLSEbm6DFs A3l...
APPRAISE URINE MICROALBUMIN COLLECTION KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
IMAGINE H.E.
FDA 510(k)
FDA Class 2
·Dental
LOCKING SCREW, FULLY THREADED 4X28 MM
FDA Adverse Event
Injury
·STRYKER TRAUMA KIEL·Product code HWC·January 4, 2007
OLYMPUS TRACHEAL INTUBATION FIBERSCOPE
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code EQN·March 7, 2013
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·March 28, 2011
CRYSTALENS
FDA Adverse Event
Injury
·EYEONICS, INC.·Product code HQL·April 21, 2008
SYNCHRO GUIDEWIRE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SALT LAKE CITY·Product code DQX·April 8, 2010
SYNCHRO GUIDEWIRE
FDA Adverse Event
Death
·BOSTON SCIENTIFIC - SALT LAKE CITY·Product code DQX·August 2, 2010
SYNCHRO GUIDEWIRE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - SALT LAKE CITY·Product code DQX·May 27, 2010
SYNCHRO GUIDEWIRE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - SALT LAKE CITY·Product code DQX·April 15, 2010
ATTUNE MEDIAL DOME PAT 41MM
FDA Adverse Event
Injury
·DEPUY IRELAND - 9616671·Product code JWH·June 5, 2023
SYNCHRO-14 STRAIGHT 200-35CM
FDA Adverse Event
Malfunction
·STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY·Product code DQX·December 12, 2023
SYNCHRO-10 STRAIGHT 200CM
FDA Adverse Event
Malfunction
·STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY·Product code DQX·October 13, 2023
SYNCHRO-14 STRAIGHT 200-35CM
FDA Adverse Event
Malfunction
·STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY·Product code DQX·November 13, 2023
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