12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SIASCOPE V
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MONOJECT SAFETY NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
HEART 2006
FDA 510(k)
FDA Class 2
·Cardiovascular
MAGELLAN
FDA Adverse Event
Malfunction
·CARDINAL HEALTH, INC.·Product code FMI·September 6, 2023
PASS LP - LIAPASS
FDA Adverse Event
Injury
·MEDICREA TECHNOLOGIES·Product code MNI·March 29, 2013
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·April 17, 2013
TRIATHLON PS FEM COMPONENT, CEMENTED
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code JWH·April 13, 2011
QUICKIE
FDA Adverse Event
Injury
·SUNRISE MEDICAL·Product code ITI·June 17, 2008
O-ARM O2 IMAGING SYSTEM
FDA Adverse Event
Malfunction
·SANMINA -SCI SYSTEMS·Product code OWB·November 4, 2021
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
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
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015