13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EQUINOXE REVERSE SHOULDER SYSTEM FRACTURE HUMERAL ADAPTER TRAY AND LOCKING SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
MODIFICATION TO XIA SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
VIEW READING STATION
FDA 510(k)
FDA Class 2
·Radiology
LTV 1200 VENTILATOR
FDA Adverse Event
Malfunction
·VYAIRE MEDICAL, INC·Product code CBK·November 13, 2023
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 23, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 13, 2011
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD·Product code FRN·July 3, 2008
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code DZI·October 6, 2020
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code DZI·July 15, 2025
NSK
FDA Adverse Event
Malfunction
·NAKANISHI INC.·Product code ELC·September 9, 2016
LTV 1200 VENTILATOR
FDA Adverse Event
Malfunction
·VYAIRE MEDICAL, INC·Product code CBK·December 13, 2023
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