17 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
UNISIGHT MAMMOGRAPHY VIEWER, MODEL 4.0
FDA 510(k)
FDA Class 2
·Radiology
REPROCESSED DISPOSABLE TROCARS
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
TRILLIUM TRI-OPTIC MEASUREMENT CELL, MODEL TMC 25T, TMC38 T, TMC 50T
FDA 510(k)
FDA Class 2
·Cardiovascular
BD ULTRASAFE X100L PR CLEAR SSL NVS STEIN
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code MEG·July 26, 2019
ULTRASAFE X100L PR PLUM SSL NVS STEIN
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code MEG·September 26, 2019
ULTRASAFE X100L PR PLUM SSL NVS STEIN
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code MEG·August 21, 2019
ULTRASAFE X100L PR PLUM SSL NVS STEIN
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code MEG·April 24, 2019
ULTRASAFE X100L PR PLUM SSL NVS STEIN
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code MEG·October 3, 2019
INTRA-AORTIC BALLOON
FDA Adverse Event
Injury
·DATASCOPE CORP·Product code DSP·April 11, 2013
PACER GAIT TRAINER
FDA Adverse Event
Injury
·RIFTON EQUIPMENT·Product code INN·June 17, 2008
TRIDENT ACETABULAR SYSTEM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code LPH·April 13, 2011
ULTRASAFE X100L PR PLUM SSL NVS STEIN
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code MEG·August 23, 2019
ULTRASAFE X100L PR PLUM SSL NVS STEIN
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·March 28, 2019
ULTRASAFE X100L PR GREY SSL SDZ
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code MEG·September 11, 2019
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