18 results
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28ms
·
Sources: EU EUDAMED, US FDA
CENTERPULSE, SPINE-TECH DIVISION CEMENT RESTRICTOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Spine Innovation Interbody System
FDA UDI
SPINE INNOVATION, LLC·00817722020236·Expandable Implant 0° x 12mm W x 15mm H x 26mm L
Genemed®
FDA UDI
SAKURA FINETEK U.S.A., INC.·00615233010629·anti-HER2 Rabbit Monoclonal Antibody [EP3], Rea...
COATED VICRYL PLUS ANTIBACTERIAL SUTURE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code GAM·April 20, 2006
COATED VICRYL PLUS ANTIBACTERIAL SUTURE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code GAM·April 20, 2006
COATED VICRYL PLUS ANTIBACTERIAL SUTURE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code GAM·April 20, 2006
COATED VICRYL PLUS ANTIBACTERIAL SUTURE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code GAM·April 20, 2006
SURGICAL SYSTEM WITH CRYOGUIDE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SUPER SECUR-FIT HA HIP STEMS AND SUPER SECUR-FIT PLUS HA HIP STEMS
FDA 510(k)
FDA Class 2
·Orthopedic
COATED VICRYL PLUS ANTIBACTERIAL SUTURE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code GAM·April 25, 2006
COATED VICRYL PLUS ANTIBACTERIAL SUTURE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code GAM·April 21, 2006
CAPIOX HEMOCONCENTRATOR
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code KDI·March 3, 2016
POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS
FDA Adverse Event
Other
·GLAXOSMITHKLINE·Product code EFT·March 22, 2013
MINICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·March 17, 2011
UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code MMI·March 31, 2008
CAPIOX RX OXYGENATOR
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·July 31, 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
The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018