16 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OSSIX -PLUS
FDA 510(k)
FDA Class 2
·Dental
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690185406·Revision Knee Spiral Reamer- Hudson Short Flute...
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809842449·FOR MEN 30-40 MM HG KNEE HIGH OPEN TOE SMALL BL...
Mariner Outrigger
FDA UDI
Seaspine Orthopedics Corporation·10889981174163·L Con, Side-Loading, L, 16mm, 260mm
1.2MM OSTEOMED AUTO-DRIVE SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
VECTORSURGE 4 INTERFERENTIAL THERAPY UNIT MODEL VS 460
FDA 510(k)
FDA Class 2
·Physical Medicine
SYNCHRO GUIDEWIRE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORP.·Product code DQX·October 16, 2009
EASYTRAK 2
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code OJX·April 11, 2013
ALTRUA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·April 13, 2011
ZERO TIP NITINOL STONE RETRIEVAL BASKET
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FFL·May 28, 2008
RAD-8
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code DQA·February 4, 2016
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
SYNCHRO2-14 SUPPORT STRAIGHT 215CM
FDA Adverse Event
Malfunction
·STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY·Product code DQX·December 14, 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