19 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
DURALOC ACETABULAR CUP SYSTEM, 36MM MARATHON +4 POLYETHYLENE LINER
FDA 510(k)
FDA Class 2
·Orthopedic
Endo Carry-on Procedure Kit
FDA UDI
MEDIVATORS INC.·40677964055100·Endo Carry-on Procedure Kit Includes Basin, Enz...
Armstrong
FDA UDI
MEDTRONIC XOMED, INC.·00763000038540·VENT TUBE 1010171 50PK ARMSTRNG BEV GROM
Armstrong
FDA UDI
MEDTRONIC XOMED, INC.·00681490028219·VENT TUBE 1010171 50PK ARMSTRNG BEV GROM
Medallion®
FDA UDI
Merit Medical Systems, Inc.·00884450543924·
UNBRANDED
FDA UDI
FGX INTERNATIONAL INC.·00193033102077·
CBYON SURGICAL OPERATING SYSTEM (SOS)
FDA 510(k)
FDA Class 2
·Neurology
DELTA 16 TACT
FDA 510(k)
FDA Class 2
·Radiology
Truliant
FDA UDI
Exactech, Inc.·10885862534286·TRULIANT CC 1/3 AUGMENT INSTRUMENT TRAY, UPPER
ECAREMANAGER V3.6
FDA Adverse Event
Malfunction
·VISICU·Product code MSX·September 21, 2009
ECAREMANAGER V3.6
FDA Adverse Event
Malfunction
·VISICU·Product code MSX·December 14, 2009
ENDEAVOR SPRINT RX
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code NIQ·March 19, 2013
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·February 11, 2011
VITROS 5, 1 FS CHEMISTRY SYSTEM
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code JJE·March 7, 2008
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·May 20, 2014
CD HORIZON
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·May 16, 2016
SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code MQP·October 30, 2017
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
paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024