9 results
·
22ms
·
Sources: EU EUDAMED, US FDA
OPTIPOINT CORNEAL MARKER, MODEL VPT-OPT-450
FDA 510(k)
FDA Class 1
·Ophthalmic
TRIDENT POROUS TITANIUM ACETABULAR COMPONENT WITH PERI-APATITE COATING
FDA 510(k)
FDA Class 2
·Orthopedic
CNS-9700 SERIES CENTRAL NURSE STATION AND ACCESSORIES
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 6, 2025
RAD-57 PULSE CO-OXIMETER
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code DQA·July 26, 2023
VISIONAIRE LEGION FE
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code KDC·April 11, 2013
TRIDENT PSL HA SOLID BACK 46MM
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS MAHWAH·Product code MEH·May 28, 2008
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·April 13, 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