11 results
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27ms
·
Sources: EU EUDAMED, US FDA
PROXILOCK HIP PROSTHESIS; SIZE 12/36
FDA 510(k)
FDA Class 2
·Orthopedic
Healqu
FDA UDI
Healqu LLC·00819143021069·Healqu Bordered Gauze Dressing 6x6 Box of 30
PB560 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN·Product code CBK·August 22, 2011
OCU-FLEX-49 SPHERICAL, TORIC, ASPHERICAL AND TORIC ASPHERICAL (HIOXIFILCON B) SOFT CONTACT LENSES FOR DAILY WEAR
FDA 510(k)
FDA Class 2
·Ophthalmic
ROCHE COBAS TAQMAN ANALYZER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PB560 VENTILATOR X1
FDA Adverse Event
Malfunction
·NELLCOR PURITAN BENNETT·Product code CBK·April 20, 2011
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·March 27, 2013
ENDEAVOR RESOLUTE RX CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC CARDIOVASCULAR GALWAY·Product code NIQ·February 24, 2011
EMBRACE PUMP
FDA Adverse Event
Malfunction
·ROSS PRODUCTS DIVISION·Product code LZH·March 28, 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
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024