12 results
·
26ms
·
Sources: EU EUDAMED, US FDA
FETAL MONITORING TRANSDUCER STRAP
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814534·GENUMEDI SAND SIZE II
Brigade
FDA UDI
Nuvasive, Inc.·00887517459848·Brigade HL Trial, 8x38x28mm 30°
AXSOS
FDA UDI
Stryker GmbH·07613154485468·Lid for Base - Instruments
INTEGRA ELECTRODE TUNNELING NEEDLE
FDA 510(k)
FDA Class 2
·Neurology
RAPID EXCHANGE TAPERTOME
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SM HYBRID GLENOID BASE 4MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBF·March 8, 2024
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 9, 2013
RADIANCE
FDA Adverse Event
Malfunction
·RADIOMETER MEDICAL APS·Product code JQP·February 14, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·November 18, 2010
ANATOMICAL SHOULDER DOMELOCK, DOME, CENTRIC
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code PHX·September 15, 2023
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