20 results
·
24ms
·
Sources: EU EUDAMED, US FDA
CSBP-001A BODY ORGAN PERFUSION SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
AURENORM 75 KF
FDA 510(k)
FDA Class 2
·Dental
DERMASAFE CHEMO PLUS POWDER FREE NEOPRENE EXAMINATION GLOVE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
FDA 510(k)
FDA Class 1
·General Hospital
BD INTIMA-II 20GAX1.16IN PRN SLM
FDA Adverse Event
Malfunction
·BD SUZHOU (MDS)·Product code FOZ·November 26, 2024
ICL (IMPLANTABLE COLLAMER LENS)
FDA Adverse Event
Malfunction
·STAAR SURGICAL COMPANY·Product code MTA·April 29, 2013
RESTORE RECHARGEABLE NEUROMODULATION
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·April 20, 2011
CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code KRH·July 21, 2008
NDEHP PRIMARY PLUM PREPIERCED Y
FDA Adverse Event
Malfunction
·HOSPIRA HOLDINGS DE COSTA RICA LTD.·Product code FRN·April 25, 2013
BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM
FDA Adverse Event
Malfunction
·BD SUZHOU (MDS)·Product code FOZ·December 17, 2024
BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM
FDA Adverse Event
Malfunction
·BD SUZHOU (MDS)·Product code FOZ·January 15, 2025
BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM
FDA Adverse Event
Malfunction
·BD SUZHOU (MDS)·Product code FOZ·January 17, 2025
BDINTIMA-II Y 20GAX1.16IN PRN/EC SLM
FDA Adverse Event
Malfunction
·BD SUZHOU (MDS)·Product code FOZ·January 17, 2025
BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM
FDA Adverse Event
Malfunction
·BD SUZHOU (MDS)·Product code FOZ·July 23, 2025
BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM
FDA Adverse Event
Malfunction
·BD SUZHOU (MDS)·Product code FOZ·April 4, 2025
BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM
FDA Adverse Event
Malfunction
·BD SUZHOU (MDS)·Product code FOZ·March 21, 2025
BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM
FDA Adverse Event
Malfunction
·BD SUZHOU (MDS)·Product code FOZ·February 28, 2025
BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM
FDA Adverse Event
Malfunction
·BD SUZHOU (MDS)·Product code FOZ·January 7, 2025
BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM
FDA Adverse Event
Malfunction
·BD SUZHOU (MDS)·Product code FOZ·April 23, 2025
BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM
FDA Adverse Event
Malfunction
·BD SUZHOU (MDS)·Product code FOZ·March 10, 2025
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