10 results
·
25ms
·
Sources: EU EUDAMED, US FDA
PAD, EXAMINING TABLE
FDA 510(k)
FDA Class 1
·General Hospital
ACUMED
FDA UDI
Acumed LLC·10806378052569·Polarus® 3 Tray 6
ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SOLEX CATHETER, MODEL SL2593
FDA 510(k)
FDA Class 2
·Cardiovascular
9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 4, 2014
PULSE GEN MODEL 103
FDA Adverse Event
Injury
·CYBERONICS INC·Product code LYJ·October 23, 2012
BRAVO
FDA Adverse Event
Malfunction
·GIVEN IMAGING LTD.·Product code FFT·May 26, 2015
SMR GLENOID BASEPLATE STANDARD
FDA Adverse Event
Injury
·LIMACORPORATE SPA·Product code KWS·April 18, 2019
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021
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