9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VARIAX ELBOW SYSTEM PLATE LINE EXTENSION
FDA 510(k)
FDA Class 2
·Orthopedic
NEURO-TRAIN III (3)
FDA 510(k)
FDA Class 2
·Physical Medicine
TROJAN PASSION BERRY GEL
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ROUND FILTER POLYPROVPYLENE
FDA Adverse Event
Malfunction
·SPS MEDICAL SUPPLY CORP·Product code FRG·June 25, 2013
STENOSCOP
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 26, 2013
PINN MAR NEUT 56ODX32ID
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code LPH·September 16, 2014
GENDER SOLUTION NK-FLEX PROLONG ART SURFACE
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code JWH·April 12, 2011
MDLR CNLTD TRIDRV DRVR
FDA Adverse Event
Malfunction
·EXACTECH, INC.·Product code LXH·August 29, 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