9 results
·
28ms
·
Sources: EU EUDAMED, US FDA
MEDLINE STRIDER MIDI 4
FDA 510(k)
FDA Class 2
·Physical Medicine
7F LAUNCHER GUIDE CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
HYDROCISION ARTHROJET SYSTEM WITH CAUTERY AND BURR
FDA 510(k)
FDA Class 2
·Orthopedic
COULTER LH 750 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·March 31, 2016
XMAX MOTOR
FDA Adverse Event
Malfunction
·THE ANSPACH EFFORT, INC.·Product code ERL·April 2, 2013
ENDOTAK RELIANCE G
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
FULL FACE MASK
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code MNT·April 7, 2011
Smith & Nephew FOOTPRINT Ultra PK Suture Anchor, 5.5mm Part Number: 72202902
FDA Enforcement
Class II
·Ongoing·Smith & Nephew, Inc.·April 29, 2020
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