21 results · 29ms · Sources: EU EUDAMED, US FDA

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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