13 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BAK'SNAP DUOPRO SAFETY SYRING (DUOPROSS) SAFETY'TRAY ALLERGY SAFETY SYRINGE TRAY
FDA 510(k)
FDA Class 2
·General Hospital
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0315040·Probe, 1.5 inch Ball, Lenke, Straight, Impaction
BODY ARRAY COIL
FDA 510(k)
FDA Class 2
·Radiology
3.5 MM LAPAROSCOPE (LG100, LG103)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AMBIENT SUPER MULTIVAC 50 IFS
FDA Adverse Event
Malfunction
·ARTHROCARE CORP.·Product code GEI·October 28, 2019
Cook
FDA UDI
COOK INCORPORATED·00827002082892·Pericardiocentesis Set
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·April 2, 2013
BHR
FDA Adverse Event
Injury
·SMITH & NEPHEW ORTHOPAEDICS, LTD.·Product code NXT·March 28, 2011
GUIDANT 4.5 MM HEARTSTRING PROXIMAL SEAL
FDA Adverse Event
Injury
·GUIDANT CARDIAC SURGERY·Product code DXC·March 24, 2008
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 TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·March 23, 2016
Spirit Plus Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
Spirit Select Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016