10 results
·
28ms
·
Sources: EU EUDAMED, US FDA
FIBER OPTIC ADAPTER #60-0897
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450198094·
G-BOND PLUS
FDA 510(k)
FDA Class 2
·Dental
ACAPELLA
FDA 510(k)
FDA Class 2
·Anesthesiology
6.0MM TI CURVED SOFT ROD 55MM
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code MNI·April 18, 2012
DXTEND STAND PE CUP D42 +9MM
FDA Adverse Event
Injury
·3003895575 DEPUY FRANCE S.A.S.-SAINT PRIEST·Product code KWS·May 9, 2014
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·October 1, 2007
IMPULSE GUIDE CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQO·October 24, 2012
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 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