10 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ULTRASOUND GENERAL PURPOSE GUIDANCE SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450566367·
ARM AUTOMATIC REPROCESSING MACHINE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SONOPREP IMPEDANCE DIAGNOSTICS (IDX) SYSTEM, MODEL D1000
FDA 510(k)
FDA Class 2
·Cardiovascular
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·May 6, 2013
0 VICRYL SUTURE UR - 6
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code GAM·September 15, 2014
UNKNOWN
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code NA·April 21, 2011
T-PIECE NEONATAL PATIENT CIRCUIT KIT, DISPOSABLE, WITH SIZE
FDA Adverse Event
Injury
·MERCURY MEDICAL·Product code CAI·September 29, 2015
NEONATAL PATIENT CIRCUIT KIT
FDA Adverse Event
Injury
·MERCURY MEDICAL·Product code CAI·September 21, 2015
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