11 results
·
27ms
·
Sources: EU EUDAMED, US FDA
COMBINATION REAMER
FDA 510(k)
FDA Class 1
·Orthopedic
INTEGRITY SPINAL CARE SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
SIEMENS MEDICAL INFORMATION BUS (MIB) PROTOCOL CONVERTER
FDA 510(k)
FDA Class 2
·Cardiovascular
GMK SPHERE TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·May 26, 2026
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·June 30, 2014
CEMENTLESS CUP
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JDI·November 12, 2010
ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·January 2, 2013
LIGACLIP** ENDOSCOPIC CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·June 14, 2013
LIGACLIP** ENDOSCOPIC CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·June 8, 2013
TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 125°
FDA Adverse Event
Injury
·STRYKER TRAUMA KIEL·Product code HSB·May 5, 2016
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