8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INFINITY ACUTE CARE SYSTEM (IACS) MONITORING SOLUTION
FDA 510(k)
FDA Class 2
·Cardiovascular
SYNTHES RESORABLE MESHES AND SHEETS
FDA 510(k)
FDA Class 2
·Orthopedic
TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 5
FDA 510(k)
FDA Class 2
·Physical Medicine
THERAPY COOL FLEX, 1304-CF-7-0.5(5)2-M-TE4BE1EB
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC. (AF-IRVINE)·Product code OAD·April 30, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 16, 2014
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·May 18, 2011
Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, LEFT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-22, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-23, c) 44, 47, 50, 53 head, Large, Item Number 314-02-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
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