9 results
·
20ms
·
Sources: EU EUDAMED, US FDA
MEERCI RETRIEVER, CONCENTRIC MICROCATHETER, MODELS 90050, 90060, 90065, 90066, 90070,90092, 90043, 90044
FDA 510(k)
FDA Class 2
·Cardiovascular
MODIFICATION TO PROVIDENT HIP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
AMLUCK AUTOMATIC DIGITAL WRIST, BLOOD PRESSURE MONITOR AK-3000/AK-4000
FDA 510(k)
FDA Class 2
·Cardiovascular
SPIROFLEX® ANGIOJET® THROMBECTOMY SET
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DXE·August 17, 2016
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·April 23, 2013
SWAN-GANZ CCO/VIPTHERMODILUTION CATHETER WITH AMC THROMBOSHIELD
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES, PR·Product code KRA·April 29, 2011
CAPSURE SP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·July 10, 2008
ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
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