21 results
·
29ms
·
Sources: EU EUDAMED, US FDA
ETHMOID SINUS SPACER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·10304040119782·NITINOL REVERSE CURVE ARCHWIRE .018 UPPER
MODEL 6492 UNIPOLAR TEMPORARY ATRIAL PACING LEAD
FDA 510(k)
FDA Class 2
·Cardiovascular
AUTO*THERM 395, MODEL ME 395
FDA 510(k)
FDA Class 2
·Physical Medicine
BHR MODULAR HEAD 46MM
FDA Adverse Event
Injury
·SMITH & NEPHEW ORTHOPAEDICS LTD·Product code KWY·January 4, 2018
CONTOUR®
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·June 19, 2025
CONTOUR TEST STRIPS
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·May 31, 2012
BREEZE2
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·February 18, 2015
CONTOUR NEXT
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·June 13, 2014
56MM AND R3 ACETABULAR SHELL
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code MBL·September 14, 2018
CONTOUR
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·April 5, 2019
CONTOUR® TS
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·August 21, 2025
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 16, 2013
MERIT CUSTOM KIT
FDA Adverse Event
Malfunction
·MERIT MEDICAL SYSTEMS, INC.·Product code DQO·March 18, 2011
ULTIMATE CHIP 130MM SIZE 3
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JDI·June 17, 2008
CONTOUR® TS
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·August 21, 2025
CONTOUR® TS
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·May 15, 2025
CONTOUR®
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·March 13, 2025
TAMPONADE URETERINE BALLOON CATHETER SET
FDA Adverse Event
Injury
·COOK UROLOGICAL·Product code KNA·October 16, 2007
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