11 results
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29ms
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Sources: EU EUDAMED, US FDA
PERSONNA PLUS SAFETY SCALPEL SYSTEM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032242·Baltic Denture System BDLoad Lw6 PLSEbil2DFl A3...
XORAN
FDA Adverse Event
Malfunction
·XORAN TECHNOLOGIES, INC.·Product code JAK·May 9, 2011
POLESTAR N-10
FDA 510(k)
FDA Class 2
·Radiology
FRESENIUS ARTERIAL BLOODLINE SETS FOR HEMODIALYSIS, FRESENIUS COMBI SETS HEMODIALYSIS BLOOD TUBING SETS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
5.0MM, DRL BIT, CANNULATED, REUSABLE
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code HTW·March 17, 2025
EON
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 29, 2013
MAXFIRE MARXMEN - STRAIGHT MENISCAL REPAIR DEVICE
FDA Adverse Event
Injury
·BIOMET SPORTS MEDICINE, INC.·Product code JDR·March 29, 2011
PROXIMATE LINEAR CUTTER RELOAD - STANDARD
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code GDW·April 18, 2008
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
The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·March 23, 2016