13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MERETE LOCKING BONE PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
exsalt PT7 Contact Layer, 6" x 6"
FDA UDI
Exciton Technologies Inc·07540127000376·The exsalt™ PT7 Contact Layer (PT7) is indicate...
RTE SNAPCONE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FHW·July 11, 2023
INSPEKTOR PRO
FDA 510(k)
FDA Class 2
·Dental
COUCH FOR TOTAL BODY RADIATION
FDA 510(k)
FDA Class 2
·Radiology
COPPERHEAD CERVICAL INTERBODY CAGE
FDA Adverse Event
Injury
·EMINENT SPINE·Product code ODP·January 8, 2016
REAR TIP EXTENDER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code N/A·December 30, 2025
RTE SNAPCONE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code FHW·February 17, 2021
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·April 19, 2013
GIANTURCO-ROEHM BIRD'S NEST JUGULAR VENA CAVA FILTER
FDA Adverse Event
Injury
·COOK, INC.·Product code DTK·May 5, 2011
UNKNOWN DEPUY FEMORAL
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code HSA·July 30, 2008
STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System. Model P6500, 510 (k) Numbers: K090036 Cleared 4/05/2010; K101409 cleared 8/2/2010; K102462, cleared 9/2/2010; add to file 2/24/2011. The SYSTEM 1E Liquid Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reuseable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.
FDA Recall
Terminated
·Steris Corporation Hopkins Facility·Product code MED·December 7, 2011
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