13 results
·
19ms
·
Sources: EU EUDAMED, US FDA
OLYMPIC BILI-LITE-PAD(TM)
FDA 510(k)
FDA Class 2
·General Hospital
LGN PS HIGH FLEX XLPE SZ 1-2 13MM
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·August 9, 2017
GII PS HI FLEX ISRT SZ 7-8 9
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·July 19, 2017
EXPLORER GRADIENT
FDA 510(k)
FDA Class 2
·Radiology
ANASTOCLIP MODELS 4001-01, 4000-02, 4000-03, 4000-04, 4004-01, 4004-02, ANASTOCLIP
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NEEDLE CASSETTE FOR SPEEDSTICH
FDA Adverse Event
Malfunction
·ARTHROCARE CORP·Product code GAT·February 22, 2012
LGN PS HIGH FLEX XLPE SZ 1-2 13MM
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·August 9, 2017
GII ARTICULAR INSERTER/EXTRACT
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code MBH·February 9, 2018
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·January 8, 2013
BARDEX ALL SILICONE FOLEY CATHETER
FDA Adverse Event
Malfunction
·PRODUCTOS PARA EL CUIDADO DE LA SALUD·Product code EZL·February 24, 2014
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·November 12, 2010
SIMPLE PREP CARBIDE
FDA Adverse Event
Injury
·COLTENE WHALEDENT INC.·Product code EJL·February 3, 2022
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