13 results · 19ms · Sources: EU EUDAMED, US FDA

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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